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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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).

Key facts

Study ID

NCT07684235

Run by

Amgen

People needed

3200

Starts

2026-07-23

Expected to finish

2028-03-19

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Alliance For Multispecialty Research - Daphne — Daphne, Alabama, United States (enrolling)
• Apex Clinical Research — San Diego, California, United States (enrolling)
• Artemis Institute for Clinical Research — San Diego, California, United States (enrolling)
• Diablo Clinical Research — Walnut Creek, California, United States (enrolling)
• Chase Medical Research LLC — Waterbury, Connecticut, United States (enrolling)
• Optimus U Corporation — Miami, Florida, United States (enrolling)
• Research Institute of South Florida — Miami, Florida, United States (enrolling)
• Clinical Neuroscience Solutions - Orlando — Orlando, Florida, United States (enrolling)
• Florida Institute for Clinical Research — Orlando, Florida, United States (enrolling)
• Flourish Research - Great Lakes Clinical Trials — Chicago, Illinois, United States (enrolling)
• Velocity Clinical Research - Baton Rouge — Baton Rouge, Louisiana, United States (enrolling)
• Headlands Research - Detroit — Southfield, Michigan, United States (enrolling)
• Velocity Clinical Research- Binghamton — Binghamton, New York, United States (enrolling)
• Rochester Clinical Research — Rochester, New York, United States (enrolling)
• Carolina Research Center Inc — Shelby, North Carolina, United States (enrolling)
• Clinical Trial Investigator Clinical Research Center — Cincinnati, Ohio, United States (enrolling)
• Velocity Clinical Research - Cincinnati — Cincinnati, Ohio, United States (enrolling)
• New Phase Research and Development — Knoxville, Tennessee, United States (enrolling)
• Elligo Clinical Research Center — Austin, Texas, United States (enrolling)
• Epic Medical Research - Red Oak — DeSoto, Texas, United States (enrolling)
• Great Lakes Research Institute - McAllen Research — Pharr, Texas, United States (enrolling)
• Clinical Trials of Texas — San Antonio, Texas, United States (enrolling)
• Pantheon Clinical Research — Bountiful, Utah, United States (enrolling)
• Chrysalis Clinical Research, LLC — St. George, Utah, United States (enrolling)
• Health Research of Hampton Roads — Newport News, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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