Recruiting
Phase 1

Maridebart Cafraglutode

Sponsor:

Amgen

Code:

NCT07908316

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Maridebart cafraglutide

Study Details

Brief summary:

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.

Conditions

Obesity

Overweight

Study ID

NCT07908316

Start date

Nov 13, 2026

Status verified date

Oct, 2026

Completion date

Feb 25, 2028

Anticipated

Primary completion date

Dec 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cohort A Group 1: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide dosing schedule 1 during treatment period

experimental: Cohort A Group 2: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide dosing schedule 2 during treatment period.

experimental: Cohort B Group 3: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide dosing schedule 1 during treatment period

experimental: Cohort B Group 4: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide dosing schedule 2 during treatment period.

experimental: Cohort C Group 5: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide dosing schedule 1 during treatment period

experimental: Cohort C Group 6: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide dosing schedule 2 during treatment period

Interventions

Maridebart cafraglutide

Administered subcutaneously.

Primary outcome measure

  • Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau) of Maridebart Cafraglutide [ Time Frame: Up To 115 days ]
  • Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide [ Time Frame: Up To 115 days ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Arizona Research Center

Recruiting

Phoenix, Arizona, United States, 85053

Catalina Research Institute LLC (CRI) - Montclair

Recruiting

Montclair, California, United States, 91763

Fortrea Clinical Research Unit - Daytona Beach

Recruiting

Daytona Beach, Florida, United States, 32117-5116

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012-3437

K2 Medical Research Orlando

Recruiting

Maitland, Florida, United States, 32751-7240

The Alliance for Multispecialty Research - Lexington

Recruiting

Lexington, Kentucky, United States, 40509

Alliance for Multispecialty Research - Knoxville

Recruiting

Knoxville, Tennessee, United States, 37920-1534

Fortrea Clinical Research Unit - Dallas

Recruiting

Dallas, Texas, United States, 75247-4968

Fortrea Clinical Research Unit Inc. - Madison

Recruiting

Madison, Wisconsin, United States, 53704-2526

More Information

Sponsor

Amgen

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Amgen on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.