NCT07908316RecruitingPhase 1
Comparing the Extent to Which Maridebart Cafraglutide is Made Available in the Body of Participants Living With Overweight or Obesity After Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA)
A Phase 1, Randomized, Double-blind, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Maridebart Cafraglutide After Switching From Glucagon-like Peptide-1 Receptor Agonists in Participants Living With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The primary purpose of the study is to assess the pharmacokinetics of maridebart cafraglutode after switching from weekly GLP-1RA in participants living with overweight or obesity.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- 13 Nov 2026
- Primary completion date
- 20 Dec 2027
- Lead sponsor
- Amgen
- Diseases
- Obesity
- NCT number
- NCT07908316
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 180
- From 13 Nov 2026 to the primary completion date, 20 Dec 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery for obesity in the last 6 months.
- Previous participation in Maridebart cafraglutide trial.
- Alcohol or drug abuse.
Other illness
- 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.
- Uncontrolled thyroid disease.
- Heart attack within 3 months.
- History of ischemic optic neuropathy.
- Positive HIV or certain positive Hepatitis B or hepatitis C.
Other
- Acute \& chronic pancreatitis within 1 year.
- Gastroparesis or gastric outlet obstruction.
- Current use of compounded weekly GLP-1RA.
- Pregnancy, breastfeeding, or planning to breastfeed.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fortrea Clinical Research Unit - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Fortrea Clinical Research Unit - Daytona Beach Coordinator of this site? Confirm its status | Daytona Beach | United States | Recruiting |
| AGA Clinical Trials Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| Alliance for Multispecialty Research Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| The Alliance for Multispecialty Research - Lexington Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Fortrea Clinical Research Unit Inc. - Madison Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| K2 Medical Research ORLANDO Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Catalina Research Institute LLC (CRI) - Montclair Coordinator of this site? Confirm its status | Montclair | United States | Recruiting |
| Arizona Research Center Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.