This study is in progress, not accepting new patients

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

a study on Diabetes Diabetes Type 2 Obesity

Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

Description

Summary

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Official Title

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

Keywords

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, Type 2 Diabetes Mellitus, T2DM, Obesity, Overweight, Maridebart Cafraglutide, AMG 133, MariTide, Chronic Weight Management

Eligibility

You can join if…

Open to people ages 18-99

  • Age ≥ 18 years.
  • Body mass index ≥ 27 kg/m2.
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  • Diagnosis of T2DM.

You CAN'T join if...

  • Type 1 diabetes mellitus.
  • Self-reported change in body weight > 5 kg within 90 days before screening.
  • Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
  • Obesity induced by other endocrinologic disorders.
  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
  • History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
  • History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  • Lifetime history of suicide attempt.

Locations

  • University of California Irvine
    Orange 5379513 California 5332921 92868 United States
  • Infinity Clinical Trials
    San Diego 5391811 California 5332921 92108 United States
  • Flourish Research
    Northridge 5377985 California 5332921 91325 United States
  • San Fernando Valley Health Institute
    Canoga Park 5333913 California 5332921 91304 United States
  • Headlands Research California
    Escondido 5346827 California 5332921 92025 United States
  • Core Healthcare Group
    Cerritos 5335663 California 5332921 90703 United States
  • Velocity Clinical Research Chula Vista
    Chula Vista 5336899 California 5332921 91911 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT06858878
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1105 people participating
Last Updated