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
NCT05669599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 592
Last updated 2026-01-20
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).
Conditions
Interventions
- BIOLOGICAL
-
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
- DRUG
-
Participants will receive placebo by SC injection.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-18
- Primary Completion
- 2024-10-08
- Completion
- 2025-12-16
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Czechia
- Germany
- Hong Kong
- Hungary
- Japan
- Poland
- South Korea
- Spain
- Taiwan
Study Locations
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