Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07575399

Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)

Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity or Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Puerto Rico Medical Research Inc., Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) ≥ 25 at screening.
  • Weight loss of ≥ 10% on weekly GLP-1 RA.
  • Stable body weight.
  • Stable dose of GLP-1RA.
  • Stable gastrointestinal (GI) tolerability.
  • Contraception for females.
  • Willingness to follow trial procedures for the duration of the trial.

Exclusion criteria

  • Obesity induced by other endocrine disorders (ex: Cushing's syndrome).
  • Previous or planned surgical, endoscopic or device-based treatment for obesity.
  • History of malignancy.
  • Type 1/Type 2 diabetes mellitus (DM).
  • Family or personal history of medullary thyroid cancer.
  • Previous participation in a Maridebart Cafraglutide trial.

Treatment and study plan

Maridebart cafraglutide

Drug

Maridebart cafraglutide will be administered via subcutaneous (SC) injection.

Other names: AMG 133

Primary outcomes

  1. Percent Change from Baseline in Body Weight at Week 68

    Time frame: Week 68

Secondary outcomes

  1. Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68

    Time frame: Week 68

  2. Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68

    Time frame: Week 68

  3. Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68

    Time frame: Week 68

  4. Plasma Concentration of Maridebart Cafraglutide at Week 68

    Time frame: Week 68

  5. Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

    Time frame: Up to 84 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 3, Open-label Trial to Evaluate the Efficacy, Safety and Tolerability of Switching From the Glucagon-like Peptide-1 Receptor Agonists to Maridebart Cafraglutide in Adult Participants With Obesity or Overweight

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 8, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.