NCT05669599

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

• Obesity
• Overweight
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Maridebart Cafraglutide	Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
DRUG	Placebo	Participants will receive placebo by SC injection.

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-10-08
• Completion: 2025-12-16
• First posted: 2023-01-03
• Last updated: 2026-01-20

Locations

78 sites across 12 countries: United States, Australia, Canada, Czechia, Germany, Hong Kong, Hungary, Japan, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study