Testing maridebart cafraglutide for weight loss in adults with type 2 diabetes and obesity

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)

Phase 3 Interventional Amgen · NCT06858878

This study tests whether a new weight loss medication called maridebart cafraglutide can help adults with type 2 diabetes and obesity lose weight better than a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment999 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Locations83 sites (Mobile, Alabama and 82 other locations)
Trial IDNCT06858878 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of maridebart cafraglutide in adults with type 2 diabetes mellitus who are overweight or obese. Participants will receive either the medication or a placebo to assess the change in body weight over the course of the study. The trial aims to demonstrate that maridebart cafraglutide is more effective than placebo in promoting weight loss among this population. The study is designed for individuals who have previously struggled with weight loss through diet and exercise.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a body mass index of 27 kg/m² or higher and a diagnosis of type 2 diabetes.

Not a fit: Patients with type 1 diabetes, significant recent weight changes, or certain serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for weight management in patients with type 2 diabetes, potentially improving their overall health and diabetes control.

How similar studies have performed: Other studies have shown promising results with similar weight loss medications in patients with type 2 diabetes, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion 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.

Exclusion Criteria:

* 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.

Where this trial is running

Mobile, Alabama and 82 other locations

+33 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.
Conditions Type 2 Diabetes Mellitus, Obesity, OverweightType 2 Diabetes MellitusT2DMObesityOverweightMaridebart CafraglutideAMG 133MariTide
Last reviewed 2026-06-13 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.