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Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)

RecruitingPhase 3

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

Who can join

Ages 18 to 99 · All sexes

Full eligibility criteria
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).

About the study

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).

What is being tested

Sponsor: Amgen · Participants: 950 · Started: Jul 29, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07684144

Locations in the U.S.

ArizonaGilbert Center for Family Medicine, Gilbert
CaliforniaSan Fernando Valley Health Institute, Canoga Park
Core Healthcare Group, Cerritos
Velocity Clinical Research Chula Vista, Chula Vista
Empire Clinical Research, Pomona
FloridaOptimus U Corporation, Miami
Indago Research and Health Center, Miami Lakes
San Marcus Research Clinic Inc, Miami Lakes
Florida Institute for Clinical Research, Orlando
Encore Medical Research of Weston LLC, Weston
Conquest Research - Winter Park, Winter Park
IowaIowa Diabetes Research, West Des Moines
KansasAlliance for Multispecialty Research Newton, Newton
Alliance for Multispecialty Research LLC, Wichita
MissouriAlliance for Multispecialty Research - Kansas City, Kansas City
NevadaPalm Research Center Inc, Las Vegas
New JerseyPremier Research, Trenton
North CarolinaWest Clinical Research, Morehead City
OhioVelocity Clinical Research - Cincinnati, Cincinnati
Velocity Clinical Research - Springdale, Cincinnati
Rhode IslandVelocity Clinical Research - Providence, East Greenwich
TexasElligo Clinical Research Center, Austin
Johnson County Clinical Trials Juno Bellaire, Bellaire
Osvaldo A Brusco MD PA, Corpus Christi
Soma Clinical Trials, LLC, Denison
JCCT- Juno Northwest Houston, Houston
VirginiaManassas Clinical Research Center Inc, Manassas

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.