Recruiting
Phase 3

Maridebart Cafraglutide

Sponsor:

Amgen

Code:

NCT07684235

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Maridebart cafraglutide

Placebo

Study Details

Brief summary:

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Conditions

Obesity

Overweight

Study ID

NCT07684235

Start date

Jul 23, 2026

Status verified date

Sep, 2026

Completion date

Mar 19, 2028

Anticipated

Primary completion date

Dec 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Completed the parent trial (2010181)
  • Completed week 72 visit in parent trial
  • Did not permanently discontinue trial intervention in parent trial
  • Randomized within 7 Days of week 72 visit in the parent trial
  • Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention

Exclusion Criteria:

  • Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
  • Body mass index ≤ 18.5 kilograms per meter square (kg/m\^2)
  • Participant has known sensitivity to any of the products or components to be administered during dosing
  • History of ischemic optic neuropathy
  • Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ.
  • Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer.
  • Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization
  • Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization.
  • Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
  • History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.
  • Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or
  • Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.
  • Major surgical procedures planned during the trial.
  • Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.
  • Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).

Study Design

Enrollment

3200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maridebart Cafraglutide Low Dose Q4W

Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 \[NCT06858839\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks(Q4W).

experimental: Maridebart Cafraglutide Medium Dose Q4W

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.

experimental: Maridebart Cafraglutide Medium Dose Q8W

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8weeks (Q8W).

placebo comparator: Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

experimental: Maridebart Cafraglutide High Dose Q4W

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.

experimental: Maridebart Cafraglutide High Dose Q8W

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.

experimental: Maridebart Cafraglutide High Dose Q12W

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W).

placebo comparator: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

experimental: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)

Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.

experimental: Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)

Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.

Interventions

Maridebart cafraglutide

Administered subcutaneously

Placebo

Administered subcutaneously.

Primary outcome measure

  • Percent Change in Body Weight from Baseline of the Parent Trial (20210181) [ Time Frame: Baseline of parent trial (20210181) to Week 48 of current trial ]
  • Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline of current trial up to 60 weeks ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Pinnacle Research Group LLC

Recruiting

Anniston, Alabama, United States, 36207

Alliance For Multispecialty Research - Daphne

Recruiting

Daphne, Alabama, United States, 36526

Alliance for Multispecialty Research Mobile

Recruiting

Mobile, Alabama, United States, 36608

Ark Clinical Research- Tustin

Recruiting

Fountain Valley, California, United States, 92708

Long Beach Clinical Trials Services Inc

Recruiting

Long Beach, California, United States, 90806

Ark Clinical Research- Long Beach

Recruiting

Long Beach, California, United States, 90815

Catalina Research Institute

Recruiting

Montclair, California, United States, 91763

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Apex Clinical Research

Recruiting

San Diego, California, United States, 92120

Artemis Institute for Clinical Research

Recruiting

San Diego, California, United States, 92123

Southern California Clinical Research

Recruiting

Santa Ana, California, United States, 92701

Diablo Clinical Research

Recruiting

Walnut Creek, California, United States, 94598

Chase Medical Research LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Clinical Neuroscience Solutions - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32256

South Florida Wellness and Clinical Research Institute

Recruiting

Margate, Florida, United States, 33063

Optimus U Corporation

Recruiting

Miami, Florida, United States, 33135

Research Institute of South Florida

Recruiting

Miami, Florida, United States, 33173

Indago Research and Health Center

Recruiting

Miami Lakes, Florida, United States, 33016

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Clinical Neuroscience Solutions - Orlando

Recruiting

Orlando, Florida, United States, 32801

Combined Research Orlando Phase I IV

Recruiting

Orlando, Florida, United States, 32807

Florida Institute for Clinical Research

Recruiting

Orlando, Florida, United States, 32825

Encore Medical Research of Weston LLC

Recruiting

Weston, Florida, United States, 33331

Center for Advanced Research and Education

Recruiting

Gainesville, Georgia, United States, 30501

Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group

Recruiting

Union City, Georgia, United States, 30291

East-West Medical Research

Recruiting

Honolulu, Hawaii, United States, 96814

Solaris Clinical Research

Recruiting

Meridian, Idaho, United States, 83646

Flourish Research - Great Lakes Clinical Trials

Recruiting

Chicago, Illinois, United States, 60640

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60077

Evanston Premier Healthcare Research LLC

Recruiting

Skokie, Illinois, United States, 60077

Alliance for Multispecialty Research Newton

Recruiting

Newton, Kansas, United States, 67114

Monroe Biomedical Research

Recruiting

Louisville, Kentucky, United States, 40213

Velocity Clinical Research - Baton Rouge

Recruiting

Baton Rouge, Louisiana, United States, 70809

Tandem Clinical Research - Marrero

Recruiting

Marrero, Louisiana, United States, 70072

Headlands Research - Detroit

Recruiting

Southfield, Michigan, United States, 48034

Prime Health and Wellness Sky Clinical Research Network Group

Recruiting

Fayette, Mississippi, United States, 39069

Alliance for Multispecialty Research - Kansas City

Recruiting

Kansas City, Missouri, United States, 64114

Palm Research Center Inc

Recruiting

Las Vegas, Nevada, United States, 89128

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Velocity Clinical Research- Binghamton

Recruiting

Binghamton, New York, United States, 13905

Rochester Clinical Research

Recruiting

Rochester, New York, United States, 14609

Accellacare of Hickory

Recruiting

Hickory, North Carolina, United States, 28601

Carolina Research Center Inc

Recruiting

Shelby, North Carolina, United States, 28150

Clinical Trial Investigator Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Velocity Clinical Research - Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Alliance for Multispecialty Research - Norman

Recruiting

Norman, Oklahoma, United States, 73069

Capital Area Research LLC

Recruiting

Newport, Pennsylvania, United States, 17074

Velocity Clinical Research - Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Tribe Clinical Research LLC Dba Mountain View Clinical Research

Recruiting

Greenville, South Carolina, United States, 29607

New Phase Research and Development

Recruiting

Knoxville, Tennessee, United States, 37909

Elligo Clinical Research Center

Recruiting

Austin, Texas, United States, 78704

Johnson County Clinical Trials Juno Bellaire

Recruiting

Bellaire, Texas, United States, 77401

Cedar Health Research, LLC

Recruiting

Dallas, Texas, United States, 75251

Epic Medical Research - Red Oak

Recruiting

DeSoto, Texas, United States, 75115

Great Lakes Research Institute El Paso Research

Recruiting

El Paso, Texas, United States, 79936

Cedar Health Research, LLC

Recruiting

Euless, Texas, United States, 76040

JCCT- Juno Northwest Houston

Recruiting

Houston, Texas, United States, 77040

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77043

Southern Endocrinology Associates PA

Recruiting

Mesquite, Texas, United States, 75149

Great Lakes Research Institute - McAllen Research

Recruiting

Pharr, Texas, United States, 78557

Clinical Trials of Texas

Recruiting

San Antonio, Texas, United States, 78229

Sugar Lakes Family Practice

Recruiting

Sugar Land, Texas, United States, 77479

Pantheon Clinical Research

Recruiting

Bountiful, Utah, United States, 84010

Alliance for Multispecialty Research Layton Research Center

Recruiting

Layton, Utah, United States, 84041

Chrysalis Clinical Research, LLC

Recruiting

St. George, Utah, United States, 84770

Washington Center for Weight Management and Research, Inc

Recruiting

Arlington, Virginia, United States, 22206

Health Research of Hampton Roads

Recruiting

Newport News, Virginia, United States, 23606

Selma Medical Associates

Recruiting

Winchester, Virginia, United States, 22601

Allegiance Research Specialists

Recruiting

Wauwatosa, Wisconsin, United States, 53226

More Information

Sponsor

Amgen

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Overweight
  • BMI
  • Obesity
  • Maridebart cafraglutide
  • Chronic weight management
  • MariTide
  • Extension
  • Long-Term

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Amgen on 2026-09-03.