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NCT07684144PHASE3Recruiting

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

Amgen

Start Date

7/29/2026

Completion Date

3/19/2028

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 Criteria

Age Range: 18 years to 99 years

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).

Interventions

DRUG

Maridebart Cafraglutide

DRUG

Placebo

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Conditions

ObesityOverweightDiabetes Mellitus, Type 2

Locations

Gilbert Center for Family Medicine

Gilbert, Arizona 85296

United States

San Fernando Valley Health Institute

Canoga Park, California 91304

United States

Core Healthcare Group

Cerritos, California 90703

United States

Velocity Clinical Research Chula Vista

La Mesa, California 91942

United States

Paradigm Clinical Research

Modesto, California 95355

United States

Empire Clinical Research

Pomona, California 91767

United States

San Marcus Research Clinic Inc

Miami, Florida 33015

United States

Optimus U Corporation

Miami, Florida 33135

United States

Indago Research and Health Center

Miami Lakes, Florida 33016

United States

Florida Institute for Clinical Research

Orlando, Florida 32825

United States

Encore Medical Research of Weston LLC

Weston, Florida 33331

United States

Conquest Research - Winter Park

Winter Park, Florida 32789

United States

Endeavor Health

Skokie, Illinois 60077

United States

Iowa Diabetes Research

West Des Moines, Iowa 50266

United States

JCCT- Juno Northwest Houston

Lenexa, Kansas 66219

United States

Alliance for Multispecialty Research Newton

Newton, Kansas 67114

United States

Alliance for Multispecialty Research LLC

Wichita, Kansas 67226

United States

Ima Clinical Research- Monroe

Monroe, Louisiana 71201

United States

Annapolis Internal Medicine, LLC

Annapolis, Maryland 21401

United States

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri 64114

United States

Palm Research Center Inc

Las Vegas, Nevada 89148

United States

Premier Research

Trenton, New Jersey 08611

United States

West Clinical Research

Morehead City, North Carolina 28557

United States

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio 45242

United States

Velocity Clinical Research - Springdale

Cincinnati, Ohio 45246

United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island 02818

United States

Elligo Clinical Research Center

Austin, Texas 78704

United States

Johnson County Clinical Trials Juno Bellaire

Bellaire, Texas 77401

United States

Osvaldo A Brusco MD PA

Corpus Christi, Texas 78414

United States

Soma Clinical Trials, LLC

Denison, Texas 75020

United States

Manassas Clinical Research Center Inc

Burke, Virginia 22015

United States

Hamilton Medical Research Group

Hamilton, Ontario L8L 5G4

Canada

Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

Matsuyama, Ehime 790-0034

Japan

Morizono Medical Clinic

Kitakyusyu-shi, Fukuoka 807-0072

Japan

Mazda Hospital of Mazda Motor Corporation

Aki-gun, Hiroshima 735-8585

Japan

Nakamoto Medical Clinic

Mito, Ibaraki 310-0826

Japan

Nakakinen Clinic

Naka, Ibaraki 311-0113

Japan

Ohishi Naika Clinic

Tsuchiura-shi, Ibaraki 300-0835

Japan

Morinaga Ueno Clinic

Kumamoto, Kumamoto 860-0863

Japan

Shiraiwa Medical Clinic

Kashiwara-shi, Osaka 582-0005

Japan

Suruga Clinic

Shizuoka, Shizuoka 424-0855

Japan

Yutenji Medical Clinic

Meguro-ku, Tokyo 153-0053

Japan

Medical Corporation Ouitsukai Kanno Naika

Mitaka-shi, Tokyo 181-0013

Japan

Latin Clinical Trial Center

San Juan, 00909

Puerto Rico

FutureMeds Birmingham

Birmingham, B21 9RY

United Kingdom