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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

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fortrea Clinical Research Unit - Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Fortrea Clinical Research Unit - Daytona Beach
Coordinator of this site? Confirm its status
Daytona BeachUnited StatesRecruiting
AGA Clinical Trials
Coordinator of this site? Confirm its status
HialeahUnited StatesRecruiting
Alliance for Multispecialty Research Knoxville
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesRecruiting
The Alliance for Multispecialty Research - Lexington
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
Fortrea Clinical Research Unit Inc. - Madison
Coordinator of this site? Confirm its status
MadisonUnited StatesRecruiting
K2 Medical Research ORLANDO
Coordinator of this site? Confirm its status
MaitlandUnited StatesRecruiting
Catalina Research Institute LLC (CRI) - Montclair
Coordinator of this site? Confirm its status
MontclairUnited StatesRecruiting
Arizona Research Center
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.