Evaluation of Maridebart Cafraglutide in Adult Participants Without 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

Obesity

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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 Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Anniston

Pinnacle Research Group LLC, Anniston, Alabama, United States, 36207

Mobile

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

Fountain Valley

Ark Clinical Research- Tustin, Fountain Valley, California, United States, 92708

Long Beach

Long Beach Clinical Trials Services Inc, Long Beach, California, United States, 90806

Long Beach

Ark Clinical Research- Long Beach, Long Beach, California, United States, 90815

Montclair

Catalina Research Institute, Montclair, California, United States, 91763

Riverside

Artemis Institute for Clinical Research, Riverside, California, United States, 92503

San Diego

Artemis Institute for Clinical Research, San Diego, California, United States, 92103

San Diego

Apex Clinical Research, San Diego, California, United States, 92120

Walnut Creek

Diablo Clinical Research, Walnut Creek, California, United States, 94598

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 ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
  • * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  • * Type 1 or Typ2 diabetes mellitus.
  • * Obesity induced by other endocrinologic disorders.
  • * Self-reported change in body weight \> 5 kg within 90 days before screening.
  • * 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