Recruiting
Phase 3

Maridebart Cafraglutide

Sponsor:

Amgen

Code:

NCT07684144

Conditions

Obesity

Overweight

Diabetes Mellitus, Type 2

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 and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

Conditions

Obesity

Overweight

Diabetes Mellitus, Type 2

Study ID

NCT07684144

Start date

Jul 29, 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) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
  • Participants completing Study 20210184 must meet the following criteria:

  • Completed the Week 72 visit in Study 20210184.
  • Did not permanently discontinue the investigational product in the parent trial (20210184).
  • Randomized within 7 days of week 72 visit in the parent trial.
  • Participants must use protocol-specified contraception during treatment and for 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 (BMI) ≤ 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 the parent trial, except for the following treated with curative intent:

  • Nonmelanoma skin cancers
  • Breast ductal carcinoma in situ
  • Cervical carcinoma in situ
  • Prostate cancer in situ
  • Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative\[s\]) history of medullary thyroid carcinoma (MTC).
  • Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization.
  • Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the 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, 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

950 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 (20210184 \[NCT06858878\]) 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 8 weeks (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.

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 (20210184) [ Time Frame: Baseline of parent trial (20210184) 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

Gilbert Center for Family Medicine

Recruiting

Gilbert, Arizona, United States, 85296

San Fernando Valley Health Institute

Recruiting

Canoga Park, California, United States, 91304

Core Healthcare Group

Recruiting

Cerritos, California, United States, 90703

Velocity Clinical Research Chula Vista

Recruiting

Chula Vista, California, United States, 91911

Empire Clinical Research

Recruiting

Pomona, California, United States, 91767

Optimus U Corporation

Recruiting

Miami, Florida, United States, 33135

San Marcus Research Clinic Inc

Recruiting

Miami Lakes, Florida, United States, 33014

Indago Research and Health Center

Recruiting

Miami Lakes, Florida, United States, 33016

Florida Institute for Clinical Research

Recruiting

Orlando, Florida, United States, 32825

Encore Medical Research of Weston LLC

Recruiting

Weston, Florida, United States, 33331

Conquest Research - Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Iowa Diabetes Research

Recruiting

West Des Moines, Iowa, United States, 50266

Alliance for Multispecialty Research Newton

Recruiting

Newton, Kansas, United States, 67114

Alliance for Multispecialty Research LLC

Recruiting

Wichita, Kansas, United States, 67226

Alliance for Multispecialty Research - Kansas City

Recruiting

Kansas City, Missouri, United States, 64114

Palm Research Center Inc

Recruiting

Las Vegas, Nevada, United States, 89128

Premier Research

Recruiting

Trenton, New Jersey, United States, 08611

West Clinical Research

Recruiting

Morehead City, North Carolina, United States, 28557

Velocity Clinical Research - Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45242

Velocity Clinical Research - Springdale

Recruiting

Cincinnati, Ohio, United States, 45246

Velocity Clinical Research - Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Elligo Clinical Research Center

Recruiting

Austin, Texas, United States, 78704

Johnson County Clinical Trials Juno Bellaire

Recruiting

Bellaire, Texas, United States, 77401

Osvaldo A Brusco MD PA

Recruiting

Corpus Christi, Texas, United States, 78414

Soma Clinical Trials, LLC

Recruiting

Denison, Texas, United States, 75020

JCCT- Juno Northwest Houston

Recruiting

Houston, Texas, United States, 77040

Manassas Clinical Research Center Inc

Recruiting

Manassas, Virginia, United States, 20110

More Information

Sponsor

Amgen

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Type 2 Diabetes Mellitus
  • T2DM
  • BMI
  • Obesity
  • Overweight
  • Maridebart Cafraglutide
  • MariTide
  • Chronic Weight Management
  • 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.