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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight, Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT05669599

Run by

Amgen

People needed

592

Starts

2023-01-18

Expected to finish

2025-12-16

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Foothills Research Center — Phoenix, Arizona, United States
• HonorHealth — Scottsdale, Arizona, United States
• Ark Clinical Research- Long Beach — Long Beach, California, United States
• Ark Clinical Research- Tustin — Tustin, California, United States
• Orange County Research Center — Tustin, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Alliance for Multispecialty Research Miami — Coral Gables, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• East-West Medical Research — Honolulu, Hawaii, United States
• University of Chicago — Chicago, Illinois, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Alliance for Multispecialty Research Newton — Newton, Kansas, United States
• Louisville Metabolic and Atherosclerosis Research Center — Louisville, Kentucky, United States
• Tandem Clinical Research - Marrero — Marrero, Louisiana, United States
• StudyMetrix Research — City of Saint Peters, Missouri, United States
• Alliance for Multispecialty Research Kansas City — Kansas City, Missouri, United States
• State University of New York Upstate Medical University — Syracuse, New York, United States
• Lucas Research — Morehead City, North Carolina, United States
• Research Innovations LLC dba Internal Medicine Care Inc — Beavercreek, Ohio, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Alliance for Multispecialty Research Norman — Norman, Oklahoma, United States
• Medical Care LLC — Elizabethton, Tennessee, United States
• PanAmerican Clinical Research LLC — Brownsville, Texas, United States
• Headlands Research Brownsville — Brownsville, Texas, United States
• Alliance for Multispecialty Research Mobile — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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