Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 trial examines the pharmacokinetics of maridebart cafraglutide in adults with overweight or obesity who transition from a weekly GLP-1 receptor agonist. Participants will switch to maridebart cafraglutide and undergo PK sampling to understand drug exposure. The study includes a 4-week run-in period with stable GLP-1RA treatment and requires specific BMI criteria and health status before enrollment. Primary outcomes focus on how the drug is absorbed, distributed, metabolized, and eliminated. Safety and tolerability will be monitored during the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 to 70 years of age.
* Body Mass Index (BMI) ≥ 25 at screening.
* BMI ≥ 23 for Asian participants at screening.
* Stable body weight (approximately 5% or less gain or loss) during the 4-week run-in period, unless the study doctor determines otherwise.
* Stable dose of weekly GLP-1RA.
* Stable gastrointestinal (GI) tolerability.
* Contraception for females.
* Stable for 3 months if obstructive sleep apnea (OSA), hypertension, hyperlipidemia, and/or hypothyroidism.
* Willingness to follow trial procedures for the duration of the trial.

Exclusion Criteria:

* Type 1/Type 2 diabetes mellitus (DM).
* Obesity induced by other endocrine disorder (ex: Cushing's syndrome).
* History of malignancy in the last 5 tears except for nonmelanoma skin cancers, cervical, or breast ductal carcinoma in situ.
* Acute \& chronic pancreatitis within 1 year.
* Uncontrolled thyroid disease.
* Gastroparesis or gastric outlet obstruction.
* Surgery for obesity in the last 6 months.
* Heart attack within 3 months.
* History of ischemic optic neuropathy.
* Positive HIV or certain positive Hepatitis B or hepatitis C.
* Current use of compounded weekly GLP-1RA.
* Previous participation in Maridebart cafraglutide trial.
* Alcohol or drug abuse.
* Pregnancy, breastfeeding, or planning to breastfeed.

Where it's running

• Arizona Research Center
  Phoenix, Arizona, United States Recruiting
• Catalina Research Institute LLC (CRI) - Montclair
  Montclair, California, United States Recruiting
• Fortrea Clinical Research Unit - Daytona Beach
  Daytona Beach, Florida, United States Recruiting
• AGA Clinical Trials
  Hialeah, Florida, United States Recruiting
• K2 Medical Research Orlando
  Maitland, Florida, United States Recruiting
• The Alliance for Multispecialty Research - Lexington
  Lexington, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.