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
- Summary
- The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide 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).
- Short 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
- Official 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-12-16
- First posted
- 2023-01-03
- Registry last updated
- 2026-01-20
- Primary completion date
- 2024-10-08
- Start date
- 2023-01-18
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Amgen
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05669599
- ClinicalTrials.gov ID
- NCT05669599
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Percent Change From Baseline to Week 52 in Body Weight
Timeframe: Baseline and Week 52
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52
Timeframe: Baseline and Week 52
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52
Timeframe: Baseline and Week 52
Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52
Timeframe: Baseline and Week 52
Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Fasting Serum Insulin
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Fasting Plasma Glucose
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)
Timeframe: Baseline and Week 52
Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide
Timeframe: Up to Week 64
Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide
Timeframe: Up to Week 64
Change from Baseline to Week 52 in Waist Circumference
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Body Weight
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA)
Timeframe: Baseline and Week 52
Analyzed in a subset of participants.
Change from Baseline to Week 52 in Lean Body Mass Using DEXA
Timeframe: Baseline and Week 52
Analyzed in a subset of participants.
Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)
Timeframe: Baseline and Week 52
Change from Baseline to Week 52 in Body Mass Index (BMI)
Timeframe: Baseline and Week 52
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Timeframe: Baseline and Week 52
Percent Change From Baseline in Total Cholesterol
Timeframe: Baseline and Week 52
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Timeframe: Baseline and Week 52
Percent Change From Baseline in non-HDL-C
Timeframe: Baseline and Week 52
Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)
Timeframe: Baseline and Week 52
Percent Change From Baseline in Triglycerides
Timeframe: Baseline and Week 52
And 1 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Healthy volunteers
- No
- 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.
- 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.
- Alliance for Multispecialty Research MobileMobile, United States
- Foothills Research CenterPhoenix, United States
- HonorHealthScottsdale, United States
- Ark Clinical Research- Long BeachLong Beach, United States
- Ark Clinical Research- TustinTustin, United States
- Orange County Research CenterTustin, United States
- Diablo Clinical ResearchWalnut Creek, United States
- Alliance for Multispecialty Research MiamiCoral Gables, United States
- Progressive Medical ResearchPort Orange, United States
- East-West Medical ResearchHonolulu, United States
- University of ChicagoChicago, United States
- Great Lakes Clinical TrialsChicago, United States
- Alliance for Multispecialty Research NewtonNewton, United States
- Louisville Metabolic and Atherosclerosis Research CenterLouisville, United States
- Tandem Clinical Research - MarreroMarrero, United States
- StudyMetrix ResearchCity of Saint Peters, United States
- Alliance for Multispecialty Research Kansas CityKansas City, United States
- State University of New York Upstate Medical UniversitySyracuse, United States
- Lucas ResearchMorehead City, United States
- Research Innovations LLC dba Internal Medicine Care IncBeavercreek, United States
- The Christ HospitalCincinnati, United States
- Alliance for Multispecialty Research NormanNorman, United States
- Medical Care LLCElizabethton, United States
- PanAmerican Clinical Research LLCBrownsville, United States
- Headlands Research BrownsvilleBrownsville, United States
And 53 more, listed on the interactive page.
- PubMed 40549887Background
- Related resource (www.amgentrials.com)
- 2023
- 2023-510470-13-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Obesity disorder Primary condition
- Type 2 diabetes mellitus