Recruiting
Phase 3

Maridebart Cafraglutide

Sponsor:

Amgen

Code:

NCT07871409

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Maridebart cafraglutide

Autoinjector

Study Details

Brief summary:

The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.

Conditions

Obesity

Overweight

Study ID

NCT07871409

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Sep 8, 2027

Anticipated

Primary completion date

Jun 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m\^2), or BMI ≥ 27 to < 30 kg/m\^2 with one of the following:

  • hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg
  • dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.
  • history of obstructive sleep apnea
  • history of cardiovascular disease
  • history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease \[MASLD\] or metabolic dysfunction-associated steatohepatitis \[MASH\])
  • At least 1 unsuccessful attempt at weight loss by diet and exercise.
  • Contraception for females.
  • Willingness to follow trial procedures for the duration of the trial.

Exclusion Criteria:

  • Obesity induced by other endocrinologic disorders.
  • Change in body weight > 5 kg within last 90 days.
  • Previous or planned surgical, endoscopic, or device-based treatment for obesity.
  • History of malignancy within the past 5 years.
  • Type 1 or Type 2 diabetes mellitus.
  • History of chronic pancreatitis or history of acute pancreatitis within last 180 days.
  • Family or personal history of medullary thyroid cancer.
  • Previous participation in a Maridebart Cafraglutide trial.

Study Design

Enrollment

230 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maridebart cafraglutide

Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide.

Interventions

Maridebart cafraglutide

Administered subcutaneously.

Autoinjector

The AI will be used by participants to self-administer SC doses of maridebart cafraglutide.

Primary outcome measure

  • Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration [ Time Frame: Weeks 12, 16, and 20 ]
  • Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration [ Time Frame: Weeks 12, 16, and 20 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Apex Clinical Research

Recruiting

San Diego, California, United States, 92120

Southern Clinical Research

Recruiting

Miami, Florida, United States, 33125

Research Institute of South Florida

Recruiting

Miami, Florida, United States, 33173

Clinical Neuroscience Solutions LLC

Recruiting

Orlando, Florida, United States, 32801

Florida Institute for Clinical Research

Recruiting

Orlando, Florida, United States, 32825

Charter Research - The Villages

Recruiting

The Villages, Florida, United States, 32162

Nsc Research

Recruiting

Johns Creek, Georgia, United States, 30024

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Solaris Clinical Research

Recruiting

Meridian, Idaho, United States, 83646

Alliance For Multispecialty Research - Oak Brook

Recruiting

Oak Brook, Illinois, United States, 60523

Flourish Research

Recruiting

Bowie, Maryland, United States, 20715

Rochester Clinical Research

Recruiting

Rochester, New York, United States, 14609

Centricity Research

Recruiting

Morehead City, North Carolina, United States, 28557

Centricity Research Dublin

Recruiting

Columbus, Ohio, United States, 43213

Epic Medical Research - Oklahoma

Recruiting

Chickasha, Oklahoma, United States, 73018

Tribe Clinical Research LLC Dba Mountain View Clinical Research

Recruiting

Greenville, South Carolina, United States, 29607

Cedar Health Research- Texas Native Health

Recruiting

Dallas, Texas, United States, 75235

Cedar Health Research, LLC

Recruiting

Dallas, Texas, United States, 75251

Soma Clinical Trials, LLC

Recruiting

Denison, Texas, United States, 75020

Epic Medical Research - Red Oak

Recruiting

DeSoto, Texas, United States, 75115

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77043

Research Physicians Network LLC

Recruiting

Houston, Texas, United States, 77089

Texas Institute of Cardiology

Recruiting

McKinney, Texas, United States, 75071

North Hills Medical Research

Recruiting

North Richland Hills, Texas, United States, 76180

More Information

Sponsor

Amgen

Last update posted

Nov 9, 2026

Last verified

Oct, 2026

Keywords

  • AMG 133

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Amgen on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.