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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06326060
Registration number
NCT06326060
Ethics application status
Date submitted
16/03/2024
Date registered
22/03/2024
Titles & IDs
Public title
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
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Scientific title
Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
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Secondary ID [1]
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U1111-1291-9210
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Secondary ID [2]
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NN9541-5015
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Universal Trial Number (UTN)
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Trial acronym
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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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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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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 - NNC0519-0130
Treatment: Drugs - Placebo
Treatment: Drugs - Tirzepatide
Experimental: Dosing scheme a: NNC0519-0130 - Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
Placebo comparator: Dosing scheme a: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Experimental: Dosing scheme b: NNC0519-0130 - Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
Placebo comparator: Dosing scheme b: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Experimental: Dosing scheme c: NNC0519-0130 - Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
Placebo comparator: Dosing scheme c: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Experimental: Dosing scheme d: NNC0519-0130 - Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
Placebo comparator: Dosing scheme d: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Experimental: Dosing scheme e: NNC0519-0130 - Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Placebo comparator: Dosing scheme e: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Experimental: Dosing scheme f: NNC0519-0130 - Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Placebo comparator: Dosing scheme f: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Active comparator: Dosing scheme g: Tirzepatide - Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Treatment: Drugs: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Treatment: Drugs: Placebo
Placebo will be administered subcutaneously.
Treatment: Drugs: Tirzepatide
Tirzepatide will be administered subcutaneously.
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Intervention code [1]
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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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Relative change in body weight
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Assessment method [1]
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Measured in percentage of body weight.
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Timepoint [1]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [1]
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Change in body weight
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Assessment method [1]
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Measured in kilograms (kg)
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Timepoint [1]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [2]
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Achievement of greater than equal to (=) 5% weight reduction
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Assessment method [2]
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Count of participants
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Timepoint [2]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [3]
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Achievement of = 10% weight reduction
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Assessment method [3]
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Count of participants
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Timepoint [3]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [4]
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Achievement of = 15% weight reduction
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Assessment method [4]
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Count of participants
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Timepoint [4]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [5]
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Achievement of = 20% weight reduction
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Assessment method [5]
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Count of participants
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Timepoint [5]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [6]
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Change in body mass index (BMI)
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Assessment method [6]
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Measured in Kilogram per meter square (Kg/m\^2)
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Timepoint [6]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [7]
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Change in waist circumference
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Assessment method [7]
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Measured in centimeter (cm)
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Timepoint [7]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [8]
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Change in glycated hemoglobin (HbA1c)
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Assessment method [8]
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Measured in percentage point (%-point)
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Timepoint [8]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [9]
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Change in fasting plasma glucose (FPG)
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Assessment method [9]
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Measured in millimoles per liter (mmol/L)
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Timepoint [9]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [10]
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Change in systolic blood pressure (SBP)
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Assessment method [10]
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Measured in milliters of mercury (mmHg)
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Timepoint [10]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [11]
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Change in high sensitivity C-Reactive protein (hsCRP)
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Assessment method [11]
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Ratio to baseline
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Timepoint [11]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [12]
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Change in total cholesterol
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Assessment method [12]
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Ratio to baseline
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Timepoint [12]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [13]
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Change in high-density lipoprotein (HDL) cholesterol
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Assessment method [13]
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Ratio to baseline
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Timepoint [13]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [14]
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Change in low-density lipoprotein (LDL) cholesterol
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Assessment method [14]
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Ratio to baseline
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Timepoint [14]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [15]
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Change in triglycerides
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Assessment method [15]
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Ratio to baseline
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Timepoint [15]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [16]
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Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score
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Assessment method [16]
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IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
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Timepoint [16]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [17]
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Change in IWQOL-Lite-CT Psychosocial composite score
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Assessment method [17]
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IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
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Timepoint [17]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [18]
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Change in IWQOL-Lite-CT Physical Function score
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Assessment method [18]
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IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
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Timepoint [18]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [19]
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Change in IWQOL-Lite-CT Total score
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Assessment method [19]
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IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).
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Timepoint [19]
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From baseline (week 0) to end of treatment (week 36)
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Secondary outcome [20]
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Number of adverse events
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Assessment method [20]
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Count of events
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Timepoint [20]
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From baseline (week 0) to end of treatment (week 40)
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Eligibility
Key inclusion criteria
* Female of non-childbearing potential, or male.
a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
* Age 18-75 years (both inclusive) at the time of signing the informed consent.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.
* a) BMI = 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
* b) BMI = 30.0 kg/m2.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
* History of type 1 or type 2 diabetes mellitus.
* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/05/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
355
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Paratus Clinical - Blacktown
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Recruitment hospital [2]
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Northern Beaches Clinical Research - Brookvale
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Recruitment hospital [3]
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Holdsworth House Clinical Research - Darlinghurst
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Recruitment hospital [4]
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Novatrials - Kotara
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Recruitment hospital [5]
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Paratus Clinical - Herston
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Recruitment hospital [6]
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University of Sunshine Coast - Sippy Downs
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Recruitment hospital [7]
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CMAX Clinical Research - Norwood
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Recruitment hospital [8]
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Emeritus Research Melbourne - Camberwell
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Recruitment hospital [9]
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Austin Health, Metabolic Disorders Centre - Heidelberg Heights
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2100 - Brookvale
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
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2289 - Kotara
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Recruitment postcode(s) [5]
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4006 - Herston
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Recruitment postcode(s) [6]
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4556 - Sippy Downs
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Recruitment postcode(s) [7]
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5067 - Norwood
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Recruitment postcode(s) [8]
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3124 - Camberwell
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Recruitment postcode(s) [9]
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3081 - Heidelberg Heights
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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0
United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
0
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United States of America
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State/province [5]
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Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kentucky
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Country [7]
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0
United States of America
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State/province [7]
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Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Missouri
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Country [9]
0
0
United States of America
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State/province [9]
0
0
North Carolina
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Ohio
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Oklahoma
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Country [12]
0
0
United States of America
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State/province [12]
0
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Pennsylvania
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Country [13]
0
0
United States of America
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State/province [13]
0
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Rhode Island
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Country [14]
0
0
United States of America
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State/province [14]
0
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South Carolina
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Country [15]
0
0
United States of America
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State/province [15]
0
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Tennessee
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Country [16]
0
0
United States of America
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State/province [16]
0
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Texas
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Country [17]
0
0
United States of America
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State/province [17]
0
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Virginia
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Country [18]
0
0
Japan
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State/province [18]
0
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Osaka
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Country [19]
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Japan
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State/province [19]
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Tokyo
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT06326060
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Transparency (dept. 2834)
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Address
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Novo Nordisk A/S
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novo Nordisk
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Address
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Country
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Phone
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(+1) 866-867-7178
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Fax
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Email
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[email protected]
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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/NCT06326060