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Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-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

Who can join

Ages 18 to 99 · All sexes

Full eligibility criteria
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).

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 or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

What is being tested

Sponsor: Amgen · Participants: 3,200 · Started: Jul 23, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07684235

Locations in the U.S.

AlabamaPinnacle Research Group LLC, Anniston
Alliance For Multispecialty Research - Daphne, Daphne
Alliance for Multispecialty Research Mobile, Mobile
CaliforniaArk Clinical Research- Tustin, Fountain Valley
Ark Clinical Research- Long Beach, Long Beach
Long Beach Clinical Trials Services Inc, Long Beach
Catalina Research Institute, Montclair
Artemis Institute for Clinical Research, Riverside
Apex Clinical Research, San Diego
Artemis Institute for Clinical Research, San Diego
Southern California Clinical Research, Santa Ana
Diablo Clinical Research, Walnut Creek
ConnecticutChase Medical Research LLC, Waterbury
FloridaClinical Neuroscience Solutions - Jacksonville, Jacksonville
Jacksonville Center for Clinical Research, Jacksonville
South Florida Wellness and Clinical Research Institute, Margate
Optimus U Corporation, Miami
Research Institute of South Florida, Miami
Indago Research and Health Center, Miami Lakes
Renstar Medical Research, Ocala
Clinical Neuroscience Solutions - Orlando, Orlando
Combined Research Orlando Phase I IV, Orlando
Florida Institute for Clinical Research, Orlando
Encore Medical Research of Weston LLC, Weston
GeorgiaCenter for Advanced Research and Education, Gainesville
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group, Union City
HawaiiEast-West Medical Research, Honolulu
IdahoSolaris Clinical Research, Meridian
IllinoisFlourish Research - Great Lakes Clinical Trials, Chicago
Endeavor Health, Skokie
Evanston Premier Healthcare Research LLC, Skokie
KansasAlliance for Multispecialty Research Newton, Newton
KentuckyMonroe Biomedical Research, Louisville
LouisianaVelocity Clinical Research - Baton Rouge, Baton Rouge
Tandem Clinical Research - Marrero, Marrero
MichiganHeadlands Research - Detroit, Southfield
MississippiPrime Health and Wellness Sky Clinical Research Network Group, Fayette
MissouriAlliance for Multispecialty Research - Kansas City, Kansas City
NevadaPalm Research Center Inc, Las Vegas
Vector Clinical Trials, Las Vegas
New YorkVelocity Clinical Research- Binghamton, Binghamton
Rochester Clinical Research, Rochester
North CarolinaAccellacare of Hickory, Hickory
Carolina Research Center Inc, Shelby
OhioClinical Trial Investigator Clinical Research Center, Cincinnati
Velocity Clinical Research - Cincinnati, Cincinnati
OklahomaAlliance for Multispecialty Research - Norman, Norman
PennsylvaniaCapital Area Research LLC, Newport
Rhode IslandVelocity Clinical Research - Providence, East Greenwich
South CarolinaTribe Clinical Research LLC Dba Mountain View Clinical Research, Greenville
TennesseeNew Phase Research and Development, Knoxville
TexasElligo Clinical Research Center, Austin
Johnson County Clinical Trials Juno Bellaire, Bellaire
Cedar Health Research, LLC, Dallas
Epic Medical Research - Red Oak, DeSoto
Great Lakes Research Institute El Paso Research, El Paso
Cedar Health Research, LLC, Euless
Biopharma Informatic, LLC, Houston
JCCT- Juno Northwest Houston, Houston
Southern Endocrinology Associates PA, Mesquite
Great Lakes Research Institute - McAllen Research, Pharr
Clinical Trials of Texas, San Antonio
Sugar Lakes Family Practice, Sugar Land
UtahPantheon Clinical Research, Bountiful
Alliance for Multispecialty Research Layton Research Center, Layton
Chrysalis Clinical Research, LLC, St. George
VirginiaWashington Center for Weight Management and Research, Inc, Arlington
Health Research of Hampton Roads, Newport News
Selma Medical Associates, Winchester
WisconsinAllegiance Research Specialists, Wauwatosa

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.