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Clinical Trials in the USA / NCT07684235
Recruiting Phase 3

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

NCT07684235 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2026-07-23
Last updated
2026-09-03

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

Maridebart cafraglutidePlacebo

Maridebart cafraglutide: Administered subcutaneously

Placebo: Administered subcutaneously.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (87)

FacilityCityRegionStatus
Pinnacle Research Group LLC Anniston Alabama Recruiting
Alliance For Multispecialty Research - Daphne Daphne Alabama Recruiting
Alliance for Multispecialty Research Mobile Mobile Alabama Recruiting
Ark Clinical Research- Tustin Fountain Valley California Recruiting
Long Beach Clinical Trials Services Inc Long Beach California Recruiting
Ark Clinical Research- Long Beach Long Beach California Recruiting
Catalina Research Institute Montclair California Recruiting
Artemis Institute for Clinical Research Riverside California Recruiting
Apex Clinical Research San Diego California Recruiting
Artemis Institute for Clinical Research San Diego California Recruiting
Southern California Clinical Research Santa Ana California Recruiting
Diablo Clinical Research Walnut Creek California Recruiting
Chase Medical Research LLC Waterbury Connecticut Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
Clinical Neuroscience Solutions - Jacksonville Jacksonville Florida Recruiting
South Florida Wellness and Clinical Research Institute Margate Florida Recruiting
Optimus U Corporation Miami Florida Recruiting
Research Institute of South Florida Miami Florida Recruiting
Indago Research and Health Center Miami Lakes Florida Recruiting
Renstar Medical Research Ocala Florida Recruiting
Clinical Neuroscience Solutions - Orlando Orlando Florida Recruiting
Combined Research Orlando Phase I IV Orlando Florida Recruiting
Florida Institute for Clinical Research Orlando Florida Recruiting
Encore Medical Research of Weston LLC Weston Florida Recruiting
Center for Advanced Research and Education Gainesville Georgia Recruiting
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group Union City Georgia Recruiting
East-West Medical Research Honolulu Hawaii Recruiting
Solaris Clinical Research Meridian Idaho Recruiting
Flourish Research - Great Lakes Clinical Trials Chicago Illinois Recruiting
Endeavor Health Skokie Illinois Recruiting
Evanston Premier Healthcare Research LLC Skokie Illinois Recruiting
Alliance for Multispecialty Research Newton Newton Kansas Recruiting
Monroe Biomedical Research Louisville Kentucky Recruiting
Velocity Clinical Research - Baton Rouge Baton Rouge Louisiana Recruiting
Tandem Clinical Research - Marrero Marrero Louisiana Recruiting
Headlands Research - Detroit Southfield Michigan Recruiting
Prime Health and Wellness Sky Clinical Research Network Group Fayette Mississippi Recruiting
Alliance for Multispecialty Research - Kansas City Kansas City Missouri Recruiting
Palm Research Center Inc Las Vegas Nevada Recruiting
Vector Clinical Trials Las Vegas Nevada Recruiting

+ 47 more sites — see the full list on the official registry below.

More Amgen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07684235 on ClinicalTrials.gov ↗ ← All trials in the USA