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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05669599
Registration number
NCT05669599
Ethics application status
Date submitted
20/12/2022
Date registered
3/01/2023
Date last updated
17/01/2024
Titles & IDs
Public title
Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
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Scientific title
A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
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Secondary ID [1]
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20190218
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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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Overweight
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Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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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
Other interventions - AMG 133
Treatment: Drugs - Placebo
Experimental: Cohort A: AMG 133 - Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Placebo Comparator: Cohort A: Placebo - Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Experimental: Cohort B: AMG 133 - Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Placebo Comparator: Cohort B: Placebo - Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Other interventions: AMG 133
Participants will receive AMG 133 by subcutaneous (SC) injection.
Treatment: Drugs: Placebo
Participants will receive placebo by SC injection.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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Percent Change From Baseline to Week 52 in Body Weight
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Assessment method [1]
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Timepoint [1]
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Baseline and Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving = 5% Reduction in Body Weight From Baseline at Week 52
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Assessment method [1]
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Timepoint [1]
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Baseline and Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving = 10% Reduction in Body Weight From Baseline at Week 52
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Assessment method [2]
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Timepoint [2]
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Baseline and Week 52
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Secondary outcome [3]
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Achievement of = 15% Reduction in Body Weight From Baseline at Week 52
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Assessment method [3]
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Timepoint [3]
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Baseline and Week 52
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Secondary outcome [4]
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Achievement of = 20% Reduction in Body Weight From Baseline at Week 52
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Assessment method [4]
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Timepoint [4]
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Baseline and Week 52
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Secondary outcome [5]
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Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)
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Assessment method [5]
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Timepoint [5]
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Baseline and Week 52
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Secondary outcome [6]
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Change from Baseline to Week 52 in Fasting Serum Insulin
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Assessment method [6]
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Timepoint [6]
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Baseline and Week 52
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Secondary outcome [7]
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Change from Baseline to Week 52 in Fasting Plasma Glucose
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Assessment method [7]
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Timepoint [7]
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Baseline and Week 52
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Secondary outcome [8]
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Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)
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Assessment method [8]
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Timepoint [8]
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Baseline and Week 52
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Secondary outcome [9]
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Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)
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Assessment method [9]
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Timepoint [9]
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Baseline and Week 52
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Secondary outcome [10]
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Maximum Observed Plasma Concentration (Cmax) of AMG 133
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Assessment method [10]
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Timepoint [10]
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Up to Week 64
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Secondary outcome [11]
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Area Under the Concentration-time Curve (AUC) of AMG 133
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Assessment method [11]
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Timepoint [11]
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Up to Week 64
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Secondary outcome [12]
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Change from Baseline to Week 52 in Waist Circumference
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Assessment method [12]
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Timepoint [12]
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Baseline and Week 52
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Secondary outcome [13]
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Change from Baseline to Week 52 in Body Weight
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Assessment method [13]
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Timepoint [13]
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Baseline and Week 52
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Secondary outcome [14]
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Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)
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Assessment method [14]
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Timepoint [14]
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Baseline and Week 52
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Secondary outcome [15]
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Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)
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Assessment method [15]
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Timepoint [15]
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Baseline and Week 52
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Secondary outcome [16]
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Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA)
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Assessment method [16]
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Analyzed in a subset of participants.
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Timepoint [16]
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Baseline and Week 52
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Secondary outcome [17]
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Change from Baseline to Week 52 in Lean Body Mass Using DEXA
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Assessment method [17]
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Analyzed in a subset of participants.
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Timepoint [17]
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Baseline and Week 52
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Secondary outcome [18]
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Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)
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Assessment method [18]
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Timepoint [18]
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Baseline and Week 52
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Secondary outcome [19]
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Change from Baseline to Week 52 in Body Mass Index (BMI)
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Assessment method [19]
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Timepoint [19]
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Baseline and Week 52
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Secondary outcome [20]
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Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
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Assessment method [20]
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Timepoint [20]
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Baseline and Week 52
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Secondary outcome [21]
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Percent Change From Baseline in Total Cholesterol
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Assessment method [21]
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Timepoint [21]
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Baseline and Week 52
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Secondary outcome [22]
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Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
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Assessment method [22]
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Timepoint [22]
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Baseline and Week 52
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Secondary outcome [23]
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Percent Change From Baseline in non-HDL-C
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Assessment method [23]
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Timepoint [23]
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Baseline and Week 52
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Secondary outcome [24]
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Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)
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Assessment method [24]
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Timepoint [24]
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Baseline and Week 52
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Secondary outcome [25]
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Percent Change From Baseline in Triglycerides
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Assessment method [25]
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Timepoint [25]
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Baseline and Week 52
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Secondary outcome [26]
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Percent Change From Baseline in Free Fatty Acids (FFA)
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Assessment method [26]
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Timepoint [26]
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Baseline and Week 52
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Eligibility
Key inclusion criteria
- Age =18 years at the time of signing informed consent.
- BMI =30 kg/m^2, or =27 kg/m^2 and previous diagnosis with at least one of the
following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea,
cardiovascular disease.
- For participants in cohort B only, HbA1c = 7% and = 10% (53 to 86 mmol/mol) at
screening with an established diagnosis of type 2 diabetes mellitus for = 180 days
prior to screening and either treated with diet and exercise alone or on stable (at
least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a
sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination
therapy, per approved local label.
- History of at least one unsuccessful dietary effort to lose body weight.
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Minimum age
18
Years
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Maximum age
99
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
- Change in body weight greater than 5 kg within 3 months prior to screening.
- Obesity induced by other endocrinologic disorders.
- History of pancreatitis.
- Family or personal history of medullary thyroid carcinoma or multiple endocrine
neoplasia syndrome type 2 (MEN-2).
- History of major depressive disorder within the last 2 years.
- Any lifetime history of other major psychiatric disorder or suicide attempt.
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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
18/01/2023
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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
2/01/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
592
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital (RPAH) Clinic - Camperdown
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Recruitment hospital [2]
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Clinical Medical and Analytical eXellence CMAX - Adelaide
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Recruitment hospital [3]
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Monash Medical Centre - Clayton
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Recruitment hospital [4]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [5]
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Austin Health, Heidelberg Repatriation Hospital - Heidelberg Heights
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Recruitment hospital [6]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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2006 - Camperdown
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3146 - Clayton
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3081 - Heidelberg Heights
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Recruitment postcode(s) [6]
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3004 - Melbourne
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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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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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Country [5]
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United States of America
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State/province [5]
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Hawaii
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Country [6]
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United States of America
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State/province [6]
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Illinois
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Country [7]
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United States of America
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State/province [7]
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Kansas
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Country [8]
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United States of America
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State/province [8]
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Kentucky
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United States of America
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Louisiana
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United States of America
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State/province [10]
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Missouri
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United States of America
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State/province [11]
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New York
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Country [12]
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United States of America
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North Carolina
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Ohio
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United States of America
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Oklahoma
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United States of America
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Tennessee
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United States of America
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Texas
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Praha 1
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Czechia
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Praha 2
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Czechia
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Praha 4
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Leipzig
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Hong Kong
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Shatin, New Territories
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Hungary
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Budapest
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Hungary
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Encs
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Hungary
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Pecs
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Ibaraki
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Goyang-si, Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Wroclaw
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Spain
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Andalucía
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Spain
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Cataluña
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Spain
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Galicia
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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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
The study aims to compare and assess the dose response of 3 selected doses of AMG 133
compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in
participants with overweight or obesity without diabetes mellitus (Cohort A) and in
participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05669599
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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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MD
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Address
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Amgen
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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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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05669599
Download to PDF