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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05567796
Registration number
NCT05567796
Ethics application status
Date submitted
3/10/2022
Date registered
5/10/2022
Titles & IDs
Public title
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
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Scientific title
Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity
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Secondary ID [1]
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Universal Trial Number (UTN)
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Secondary ID [2]
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NN9838-4608
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Universal Trial Number (UTN)
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Trial acronym
REDEFINE 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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0
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Condition category
Condition code
Diet and Nutrition
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0
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0
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Obesity
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Metabolic and Endocrine
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0
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cagrilintide
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo cagrilintide
Treatment: Drugs - Placebo semaglutide
Experimental: Cagrisema s.c. 2.4 mg/2.4 mg - Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.
Active comparator: Cagrilintide s.c. 2.4 mg - Participants will receive cagrilintide s.c. 2.4 mg and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.
Active comparator: Semaglutide s.c. 2.4 mg - Participants will receive semaglutide s.c. 2.4 mg and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.
Placebo comparator: Placebo s.c. - Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.
Treatment: Drugs: Cagrilintide
Cagrilintide will be administered subcutaneously.
Treatment: Drugs: Semaglutide
Participants will recieve semaglutide subcutaneously.
Treatment: Drugs: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide.
Treatment: Drugs: Placebo semaglutide
Participants will receive placebo matched to semaglutide.
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
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Assessment method [1]
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0
Measured in percentage (%)
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Timepoint [1]
0
0
From baseline (week 0) to end of treatment (week 68)
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Primary outcome [2]
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0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
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Assessment method [2]
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0
Measured as count of participants
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Timepoint [2]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [1]
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0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 20% weight reduction
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Assessment method [1]
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0
Measured as count of participant
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Timepoint [1]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [2]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 25% weight reduction
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Assessment method [2]
0
0
Measured as count of participant
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Timepoint [2]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [3]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 30% weight reduction
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Assessment method [3]
0
0
Measured as count of participant
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Timepoint [3]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [4]
0
0
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg; and CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
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Assessment method [4]
0
0
Measured as percentage (%)
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Timepoint [4]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [5]
0
0
CagriSema 0.5 mg/0.5 mg versus placebo: Relative change in body weight
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Assessment method [5]
0
0
Measured as percentage (%)
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Timepoint [5]
0
0
From baseline (week 0) to week 8
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Secondary outcome [6]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
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Assessment method [6]
0
0
Measured as percentage (%)
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Timepoint [6]
0
0
From baseline (week 0) to week 20
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Secondary outcome [7]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
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Assessment method [7]
0
0
Measured in centimeters (cm)
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Timepoint [7]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [8]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in systolic blood pressure (SBP)
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Assessment method [8]
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0
Measured in millimeters of mercury (mmHg)
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Timepoint [8]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [9]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score
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Assessment method [9]
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0
Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
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Timepoint [9]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [10]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score
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Assessment method [10]
0
0
Measured as score points. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.
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Timepoint [10]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [11]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in body weight
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Assessment method [11]
0
0
Measured in kilograms (kg)
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Timepoint [11]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [12]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo, semalutide 2.4 mg and cagrilintide 2.4 mg: Change in body mass index (BMI)
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Assessment method [12]
0
0
Measured in kilogram per square meter (kg/m\^2)
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Timepoint [12]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [13]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg: Improvement in weight category
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Assessment method [13]
0
0
Measured as count of participants. The categories are: BMI, underweight less than (\<) 18.5, normal weight 18.5 to \<25, overweight 25.0 to \<30, obesity class I 30 to \< 35, obesity class II 35 to \< 40, obesity class III \>40.
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Timepoint [13]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [14]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Glycated Haemoglobin (HbA1c)
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Assessment method [14]
0
0
Measured as percentage (%)
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Timepoint [14]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [15]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in HbA1c
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Assessment method [15]
0
0
Measured as millimoles per mole (mmol/mol).
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Timepoint [15]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [16]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Fasting Plasma Glucose (FPG)
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Assessment method [16]
0
0
Measured as millimoles per liter (mmol/L).
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Timepoint [16]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [17]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in FPG
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Assessment method [17]
0
0
Measured as milligrams per deciliter (mg/dL).
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Timepoint [17]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [18]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in fasting serum insulin
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Assessment method [18]
0
0
Measured as ratio
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Timepoint [18]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [19]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Diastolic Blood Pressure (DBP)
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Assessment method [19]
0
0
Measured in mmHg
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Timepoint [19]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [20]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in total cholesterol
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Assessment method [20]
0
0
Measured as ratio
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Timepoint [20]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [21]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol
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Assessment method [21]
0
0
Measured as ratio
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Timepoint [21]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [22]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol
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Assessment method [22]
0
0
Measured as ratio
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Timepoint [22]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [23]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol
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Assessment method [23]
0
0
Measured as ratio
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Timepoint [23]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [24]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Triglycerides
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Assessment method [24]
0
0
Measured as ratio
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Timepoint [24]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [25]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Free fatty acids
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Assessment method [25]
0
0
Measured as ratio
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Timepoint [25]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [26]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in waist circumference
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Assessment method [26]
0
0
Measured in centimeters (cm)
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Timepoint [26]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [27]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in SBP
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Assessment method [27]
0
0
Measured in mmHg
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Timepoint [27]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [28]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in total cholesterol
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Assessment method [28]
0
0
Measured as ratio
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Timepoint [28]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [29]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in HDL
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Assessment method [29]
0
0
Measured as ratio
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Timepoint [29]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [30]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in LDL
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Assessment method [30]
0
0
Measured as ratio
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Timepoint [30]
0
0
From baseline (week 0) to end of treatment (week 68)
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Secondary outcome [31]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in VLDL
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Assessment method [31]
0
0
Measured as ratio
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Timepoint [31]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [32]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in Triglycerides
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Assessment method [32]
0
0
Measured as ratio
Query!
Timepoint [32]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [33]
0
0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in Free fatty acids
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Assessment method [33]
0
0
Measured as ratio
Query!
Timepoint [33]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [34]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight (Measured in kilograms (kg))
Query!
Assessment method [34]
0
0
Measured in kilograms (kg).
Query!
Timepoint [34]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [35]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight (Measured in percentage (%))
Query!
Assessment method [35]
0
0
Measured in percentage (%).
Query!
Timepoint [35]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [36]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Absolute change in body weight (Measured in kilograms (kg))
Query!
Assessment method [36]
0
0
Measured in kilograms (kg).
Query!
Timepoint [36]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [37]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Absolute change in body weight (Measured in percentage (%))
Query!
Assessment method [37]
0
0
Measured in percentage (%).
Query!
Timepoint [37]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [38]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as kilograms (kg))
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Assessment method [38]
0
0
Measured as kilograms (kg)
Query!
Timepoint [38]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [39]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%))
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Assessment method [39]
0
0
Measured as percentage (%)
Query!
Timepoint [39]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [40]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as kilograms (kg))
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Assessment method [40]
0
0
Measured as kilograms (kg)
Query!
Timepoint [40]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [41]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%))
Query!
Assessment method [41]
0
0
Measured as percentage (%)
Query!
Timepoint [41]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [42]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%))
Query!
Assessment method [42]
0
0
Measured as percentage (%)
Query!
Timepoint [42]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [43]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points)
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Assessment method [43]
0
0
Measured as %-points
Query!
Timepoint [43]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [44]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as percentage (%))
Query!
Assessment method [44]
0
0
Measured as percentage (%).
Query!
Timepoint [44]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [45]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as %-points)
Query!
Assessment method [45]
0
0
Measured as %-points
Query!
Timepoint [45]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [46]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg))
Query!
Assessment method [46]
0
0
Measured in kilograms (kg)
Query!
Timepoint [46]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [47]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%))
Query!
Assessment method [47]
0
0
Measured in percentage (%)
Query!
Timepoint [47]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [48]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg))
Query!
Assessment method [48]
0
0
Measured in kilograms (kg)
Query!
Timepoint [48]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [49]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%))
Query!
Assessment method [49]
0
0
Measured in percentage (%)
Query!
Timepoint [49]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [50]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score
Query!
Assessment method [50]
0
0
Measured as count of participants. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
Query!
Timepoint [50]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [51]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score
Query!
Assessment method [51]
0
0
Measured as count of participants. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.
Query!
Timepoint [51]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [52]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT - Physical Function Score
Query!
Assessment method [52]
0
0
Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
Query!
Timepoint [52]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [53]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score
Query!
Assessment method [53]
0
0
Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
Query!
Timepoint [53]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [54]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT - Total Score
Query!
Assessment method [54]
0
0
Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
Query!
Timepoint [54]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [55]
0
0
Change in Control of Eating (COEQ): Craving Control Score
Query!
Assessment method [55]
0
0
Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).
Query!
Timepoint [55]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [56]
0
0
Change in COEQ: Craving for Savoury food score
Query!
Assessment method [56]
0
0
Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).
Query!
Timepoint [56]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [57]
0
0
Change in COEQ: Hunger score
Query!
Assessment method [57]
0
0
Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).
Query!
Timepoint [57]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [58]
0
0
Change in COEQ: Craving for Sweets Score
Query!
Assessment method [58]
0
0
Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).
Query!
Timepoint [58]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [59]
0
0
Change in COEQ: Positive Mood score
Query!
Assessment method [59]
0
0
Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).
Query!
Timepoint [59]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [60]
0
0
Change in COEQ: Satiety score
Query!
Assessment method [60]
0
0
Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).
Query!
Timepoint [60]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [61]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score
Query!
Assessment method [61]
0
0
Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
Query!
Timepoint [61]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [62]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score
Query!
Assessment method [62]
0
0
Measured as count of participants.
Query!
Timepoint [62]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [63]
0
0
CagriSema 2.4 mg/2.4 mg versus placebo, semalutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline C-reactive protein (CRP)
Query!
Assessment method [63]
0
0
Measured as ratio
Query!
Timepoint [63]
0
0
From baseline (week 0) to end of treatment (week 68)
Query!
Secondary outcome [64]
0
0
Number of Treatment Emergent Adverse Events (TEAEs)
Query!
Assessment method [64]
0
0
Measured as count of events
Query!
Timepoint [64]
0
0
From baseline (week 0) to end of study-main part (week 75)
Query!
Secondary outcome [65]
0
0
Number of Treatment Emergent Serious adverse events (TESAEs)
Query!
Assessment method [65]
0
0
Measured as count of events.
Query!
Timepoint [65]
0
0
From baseline (week 0) to end of study-main part (week 75)
Query!
Eligibility
Key inclusion criteria
* Male or female
* Age above or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
19/10/2026
Query!
Actual
Query!
Sample size
Target
3400
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
Northern Beaches Clinical Research - Brookvale
Query!
Recruitment hospital [2]
0
0
Holdsworth House Clinical Research - Darlinghurst
Query!
Recruitment hospital [3]
0
0
Novatrials - Kotara
Query!
Recruitment hospital [4]
0
0
Austrials - Taringa
Query!
Recruitment postcode(s) [1]
0
0
2100 - Brookvale
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
2289 - Kotara
Query!
Recruitment postcode(s) [4]
0
0
4068 - Taringa
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oklahoma
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Rhode Island
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
South Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Tennessee
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Texas
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Virginia
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Washington
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
La Pampa
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Caba
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Ciudad de Buenos Aires
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Santiago del Estero
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Bonheiden
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Boussu
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Bruxelles
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Edegem
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Gent
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Leuven
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Kyustendil
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Blagoevgrad
Query!
Country [34]
0
0
Bulgaria
Query!
State/province [34]
0
0
Montana
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Pleven
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Plovdiv
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Ruse
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Smolyan
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Sofia
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Varna
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Yambol
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Alberta
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
British Columbia
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
New Brunswick
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Nova Scotia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Ontario
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Aarhus N
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Esbjerg
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Hellerup
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Hvidovre
Query!
Country [51]
0
0
Denmark
Query!
State/province [51]
0
0
Køge
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
Helsinki
Query!
Country [53]
0
0
Finland
Query!
State/province [53]
0
0
Kuopio
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Oulu
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Turku
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Paris
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Pierre-Benite
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Saint Herblain
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Strasbourg cedex 2
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Venissieux
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Bad Mergentheim
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Elsterwerda
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Essen
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Hamburg
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Leipzig
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Münster
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Stuttgart
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Wangen
Query!
Country [69]
0
0
India
Query!
State/province [69]
0
0
Gujarat
Query!
Country [70]
0
0
India
Query!
State/province [70]
0
0
Kerala
Query!
Country [71]
0
0
India
Query!
State/province [71]
0
0
Maharashtra
Query!
Country [72]
0
0
India
Query!
State/province [72]
0
0
New Delhi
Query!
Country [73]
0
0
India
Query!
State/province [73]
0
0
Rajasthan
Query!
Country [74]
0
0
India
Query!
State/province [74]
0
0
Tamil Nadu
Query!
Country [75]
0
0
India
Query!
State/province [75]
0
0
Delhi
Query!
Country [76]
0
0
India
Query!
State/province [76]
0
0
Hyderabad
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Cz
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
MI
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
RM
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
SI
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Bologna
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Catania
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Padova
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Roma
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Hokkaido
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Osaka
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Aichi
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Chiba-shi, Chiba
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Gunma
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Kanagawa
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Saitama
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Sendai-shi, Miyagi
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Tokyo
Query!
Country [94]
0
0
Korea, Republic of
Query!
State/province [94]
0
0
Gyeonggi-do
Query!
Country [95]
0
0
Korea, Republic of
Query!
State/province [95]
0
0
Daegu
Query!
Country [96]
0
0
Korea, Republic of
Query!
State/province [96]
0
0
Daejeon
Query!
Country [97]
0
0
Korea, Republic of
Query!
State/province [97]
0
0
Incheon
Query!
Country [98]
0
0
Korea, Republic of
Query!
State/province [98]
0
0
Seongnam-si, Gyeonggi-do
Query!
Country [99]
0
0
Korea, Republic of
Query!
State/province [99]
0
0
Seoul
Query!
Country [100]
0
0
Korea, Republic of
Query!
State/province [100]
0
0
Yangsan
Query!
Country [101]
0
0
Mexico
Query!
State/province [101]
0
0
Jalisco
Query!
Country [102]
0
0
Mexico
Query!
State/province [102]
0
0
Nuevo Leon
Query!
Country [103]
0
0
Mexico
Query!
State/province [103]
0
0
Aguascalientes
Query!
Country [104]
0
0
Netherlands
Query!
State/province [104]
0
0
Amsterdam
Query!
Country [105]
0
0
Netherlands
Query!
State/province [105]
0
0
Arnhem
Query!
Country [106]
0
0
Netherlands
Query!
State/province [106]
0
0
Hoofddorp
Query!
Country [107]
0
0
Netherlands
Query!
State/province [107]
0
0
Roosendaal
Query!
Country [108]
0
0
Netherlands
Query!
State/province [108]
0
0
Zwijndrecht
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Dolnoslaskie
Query!
Country [110]
0
0
Poland
Query!
State/province [110]
0
0
Kujawsko-Pomorskie Voivodeship
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Poland
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Kuyavian-Pomeranian Voivodeship
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Lubelskie Voivodeship
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Mazovian Voivodeship
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Mazowieckie
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State/province [115]
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Malopolskie
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State/province [116]
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Podlaskie Voivodeship
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Pomorskie
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Slaskie Voivodeship
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Warminsko-Mazurskie
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Wielkopolskie Voivodeship
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Poland
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Legnica
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Poland
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State/province [122]
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Warszawa
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Serbia
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Vojvodina
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Serbia
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Belgrade
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Serbia
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Novi Sad
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South Africa
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Gauteng
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South Africa
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KwaZulu-Natal
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South Africa
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North West
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Castilleja Dela Cuesta Sevilla
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Spain
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León
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Turkey
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Cankaya
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Turkey
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Istanbul
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Turkey
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Adana
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Turkey
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State/province [140]
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Ankara
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Turkey
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State/province [141]
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Antalya
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Turkey
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State/province [142]
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Hatay
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Turkey
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Sivas
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United Kingdom
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Blackpool
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Chester
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United Kingdom
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State/province [148]
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Chippenham
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United Kingdom
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State/province [149]
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Coventry
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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State/province [152]
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Orpington
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Country [153]
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United Kingdom
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novo Nordisk A/S
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Address
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Ethics approval
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Summary
Brief summary
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.
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Trial website
https://clinicaltrials.gov/study/NCT05567796
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Transparency (dept. 2834)
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Novo Nordisk A/S
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05567796