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Clinical Trials in the USA / NCT07684144
Recruiting Phase 3

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

NCT07684144 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2026-07-29
Last updated
2026-09-03

Condition(s) studied

ObesityOverweightDiabetes Mellitus, Type 2

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

Eligibility

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

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Gilbert Center for Family Medicine Gilbert Arizona Recruiting
San Fernando Valley Health Institute Canoga Park California Recruiting
Core Healthcare Group Cerritos California Recruiting
Velocity Clinical Research Chula Vista Chula Vista California Recruiting
Empire Clinical Research Pomona California Recruiting
Optimus U Corporation Miami Florida Recruiting
San Marcus Research Clinic Inc Miami Lakes Florida Recruiting
Indago Research and Health Center Miami Lakes Florida Recruiting
Florida Institute for Clinical Research Orlando Florida Recruiting
Encore Medical Research of Weston LLC Weston Florida Recruiting
Conquest Research - Winter Park Winter Park Florida Recruiting
Iowa Diabetes Research West Des Moines Iowa Recruiting
Alliance for Multispecialty Research Newton Newton Kansas Recruiting
Alliance for Multispecialty Research LLC Wichita Kansas Recruiting
Alliance for Multispecialty Research - Kansas City Kansas City Missouri Recruiting
Palm Research Center Inc Las Vegas Nevada Recruiting
Premier Research Trenton New Jersey Recruiting
West Clinical Research Morehead City North Carolina Recruiting
Velocity Clinical Research - Cincinnati Cincinnati Ohio Recruiting
Velocity Clinical Research - Springdale Cincinnati Ohio Recruiting
Velocity Clinical Research - Providence East Greenwich Rhode Island Recruiting
Elligo Clinical Research Center Austin Texas Recruiting
Johnson County Clinical Trials Juno Bellaire Bellaire Texas Recruiting
Osvaldo A Brusco MD PA Corpus Christi Texas Recruiting
Soma Clinical Trials, LLC Denison Texas Recruiting
JCCT- Juno Northwest Houston Houston Texas Recruiting
Manassas Clinical Research Center Inc Manassas Virginia Recruiting
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism Matsuyama Ehime Recruiting
Morizono Medical Clinic Kitakyusyu-shi Fukuoka Recruiting
Nakamoto Medical Clinic Mito Ibaraki Recruiting
Nakakinen Clinic Naka Ibaraki Recruiting
Ohishi Naika Clinic Tsuchiura-shi Ibaraki Recruiting
Morinaga Ueno Clinic Kumamoto Kumamoto Recruiting
Shiraiwa Medical Clinic Kashiwara-shi Osaka Recruiting
Suruga Clinic Shizuoka Shizuoka Recruiting
Medical Corporation Ouitsukai Kanno Naika Mitaka-shi Tokyo Recruiting
Latin Clinical Trial Center San Juan Puerto Rico Recruiting

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 NCT07684144 on ClinicalTrials.gov ↗ ← All trials in the USA