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Evaluating Maridebart Cafraglutide for Weight Management in Adults with Obesity

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

PHASE3 · Amgen · NCT06858839

This study is testing if a new weight loss medication can help adults with obesity who haven't had success losing weight before.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment3501 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen (industry)
Locations115 sites (Anniston, Alabama and 114 other locations)
Trial IDNCT06858839 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of maridebart cafraglutide compared to a placebo in adults who are overweight or obese but do not have type 2 diabetes. Participants will be evaluated for changes in body weight as the primary outcome measure. The study includes individuals with a body mass index (BMI) of 27 or higher and a history of unsuccessful weight loss attempts. The trial is designed to provide insights into the potential benefits of this medication for chronic weight management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a BMI of 27 or higher and a history of unsuccessful weight loss attempts.

Not a fit: Patients with type 1 or type 2 diabetes mellitus or those with obesity due to other endocrinologic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for effective weight management in adults struggling with obesity.

How similar studies have performed: Other studies have shown promise with similar weight management approaches, but the specific use of maridebart cafraglutide is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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.

Exclusion Criteria:

* 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.

Where this trial is running

Anniston, Alabama and 114 other locations

+65 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Obesity, Overweight, BMI, Body weight, Maridebart cafraglutide, Chronic weight management, MariTide

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.