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

Description

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

Conditions

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

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Study Overview

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Study Details

Study overview

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

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)

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

Condition
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Intervention / Treatment

-

Contacts and Locations

Mobile

Alliance for Multispecialty Research Mobile, Mobile, Alabama, United States, 36608

Gilbert

Gilbert Center for Family Medicine, Gilbert, Arizona, United States, 85296

Cerritos

Core Healthcare Group, Cerritos, California, United States, 90703

Chula Vista

Velocity Clinical Research Chula Vista, Chula Vista, California, United States, 91911

Escondido

Headlands Research California, Escondido, California, United States, 92025

Pomona

Empire Clinical Research, Pomona, California, United States, 91767

Riverside

Greenwich Clinical Trials, Riverside, Connecticut, United States, 06878

Hialeah

Indago Research and Health Center, Hialeah, Florida, United States, 33012

Miami Lakes

San Marcus Research Clinic Inc, Miami Lakes, Florida, United States, 33014

Miami

Optimus U Corporation, Miami, Florida, United States, 33135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years.
  • * Body mass index ≥ 27 kg/m\^2.
  • * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  • * Diagnosis of T2DM.
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-04-16