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

NCT07684235 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20250197
• Study Type: interventional
• Target: 3,200
• Locations: 4 countries
• Sites: 87

Brief 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).

Conditions

Overweight; Obesity

Keywords

Overweight; BMI; Obesity; Maridebart cafraglutide; Chronic weight management; MariTide; Extension; Long-Term

Outcome Measures

Primary Outcomes (2)

• Percent Change in Body Weight from Baseline of the Parent Trial (20210181)

  Baseline of parent trial (20210181) to Week 48 of current trial

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Baseline of current trial up to 60 weeks

Secondary Outcomes (11)

• Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial

  Baseline of parent trial to Week 48 of current trial

• Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial

  Baseline of parent trial to Week 48 of current trial

• Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial

  Baseline of parent trial to Week 48 of current trial

• Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline of the Parent Trial

  Baseline of parent trial to Week 48 of current trial

• Change from Baseline of the Parent Trial in Waist Circumference

  Baseline of parent trial to Week 48 of current trial

Study Arms (10)

Maridebart Cafraglutide Low Dose Q4W

EXPERIMENTAL

Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 \[NCT06858839\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks(Q4W).

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose Q4W

EXPERIMENTAL

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose Q8W

EXPERIMENTAL

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8weeks (Q8W).

Drug: Maridebart cafraglutide

Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)

PLACEBO COMPARATOR

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

Drug: Placebo

Maridebart Cafraglutide High Dose Q4W

EXPERIMENTAL

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide High Dose Q8W

EXPERIMENTAL

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide High Dose Q12W

EXPERIMENTAL

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W).

Drug: Maridebart cafraglutide

Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)

PLACEBO COMPARATOR

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

Drug: Placebo

Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)

EXPERIMENTAL

Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)

EXPERIMENTAL

Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.

Drug: Maridebart cafraglutide

Interventions

Maridebart cafraglutide DRUG

Administered subcutaneously

Also known as: AMG 133, MariTide

Maridebart Cafraglutide High Dose Q12W; Maridebart Cafraglutide High Dose Q4W; Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial); Maridebart Cafraglutide High Dose Q8W; Maridebart Cafraglutide Low Dose Q4W; Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial); Maridebart Cafraglutide Medium Dose Q4W; Maridebart Cafraglutide Medium Dose Q8W

Placebo DRUG

Administered subcutaneously.

Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial); Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (87)

Pinnacle Research Group LLC

Anniston, Alabama, 36207, United States

RECRUITING

Alliance For Multispecialty Research - Daphne

Daphne, Alabama, 36526, United States

RECRUITING

Alliance for Multispecialty Research Mobile

Mobile, Alabama, 36608, United States

RECRUITING

Ark Clinical Research- Tustin

Fountain Valley, California, 92708, United States

RECRUITING

Long Beach Clinical Trials Services Inc

Long Beach, California, 90806, United States

RECRUITING

Ark Clinical Research- Long Beach

Long Beach, California, 90815, United States

RECRUITING

Catalina Research Institute

Montclair, California, 91763, United States

RECRUITING

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

RECRUITING

Apex Clinical Research

San Diego, California, 92120, United States

RECRUITING

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

RECRUITING

Southern California Clinical Research

Santa Ana, California, 92701, United States

RECRUITING

Diablo Clinical Research

Walnut Creek, California, 94598, United States

RECRUITING

Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, 32256, United States

RECRUITING

South Florida Wellness and Clinical Research Institute

Margate, Florida, 33063, United States

RECRUITING

Optimus U Corporation

Miami, Florida, 33135, United States

RECRUITING

Research Institute of South Florida

Miami, Florida, 33173, United States

RECRUITING

Indago Research and Health Center

Miami Lakes, Florida, 33016, United States

RECRUITING

Renstar Medical Research

Ocala, Florida, 34470, United States

RECRUITING

Clinical Neuroscience Solutions - Orlando

Orlando, Florida, 32801, United States

RECRUITING

Combined Research Orlando Phase I IV

Orlando, Florida, 32807, United States

RECRUITING

Florida Institute for Clinical Research

Orlando, Florida, 32825, United States

RECRUITING

Encore Medical Research of Weston LLC

Weston, Florida, 33331, United States

RECRUITING

Center for Advanced Research and Education

Gainesville, Georgia, 30501, United States

RECRUITING

Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group

Union City, Georgia, 30291, United States

RECRUITING

East-West Medical Research

Honolulu, Hawaii, 96814, United States

RECRUITING

Solaris Clinical Research

Meridian, Idaho, 83646, United States

RECRUITING

Flourish Research - Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

RECRUITING

Endeavor Health

Skokie, Illinois, 60077, United States

RECRUITING

Evanston Premier Healthcare Research LLC

Skokie, Illinois, 60077, United States

RECRUITING

Alliance for Multispecialty Research Newton

Newton, Kansas, 67114, United States

RECRUITING

Monroe Biomedical Research

Louisville, Kentucky, 40213, United States

RECRUITING

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Tandem Clinical Research - Marrero

Marrero, Louisiana, 70072, United States

RECRUITING

Headlands Research - Detroit

Southfield, Michigan, 48034, United States

RECRUITING

Prime Health and Wellness Sky Clinical Research Network Group

Fayette, Mississippi, 39069, United States

RECRUITING

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri, 64114, United States

RECRUITING

Palm Research Center Inc

Las Vegas, Nevada, 89128, United States

RECRUITING

Vector Clinical Trials

Las Vegas, Nevada, 89128, United States

RECRUITING

Velocity Clinical Research- Binghamton

Binghamton, New York, 13905, United States

RECRUITING

Rochester Clinical Research

Rochester, New York, 14609, United States

RECRUITING

Accellacare of Hickory

Hickory, North Carolina, 28601, United States

RECRUITING

Carolina Research Center Inc

Shelby, North Carolina, 28150, United States

RECRUITING

Clinical Trial Investigator Clinical Research Center

Cincinnati, Ohio, 45212, United States

RECRUITING

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Alliance for Multispecialty Research - Norman

Norman, Oklahoma, 73069, United States

RECRUITING

Capital Area Research LLC

Newport, Pennsylvania, 17074, United States

RECRUITING

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

RECRUITING

Tribe Clinical Research LLC Dba Mountain View Clinical Research

Greenville, South Carolina, 29607, United States

RECRUITING

New Phase Research and Development

Knoxville, Tennessee, 37909, United States

RECRUITING

Elligo Clinical Research Center

Austin, Texas, 78704, United States

RECRUITING

Johnson County Clinical Trials Juno Bellaire

Bellaire, Texas, 77401, United States

RECRUITING

Cedar Health Research, LLC

Dallas, Texas, 75251, United States

RECRUITING

Epic Medical Research - Red Oak

DeSoto, Texas, 75115, United States

RECRUITING

Great Lakes Research Institute El Paso Research

El Paso, Texas, 79936, United States

RECRUITING

Cedar Health Research, LLC

Euless, Texas, 76040, United States

RECRUITING

JCCT- Juno Northwest Houston

Houston, Texas, 77040, United States

RECRUITING

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

RECRUITING

Southern Endocrinology Associates PA

Mesquite, Texas, 75149, United States

RECRUITING

Great Lakes Research Institute - McAllen Research

Pharr, Texas, 78557, United States

RECRUITING

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

RECRUITING

Sugar Lakes Family Practice

Sugar Land, Texas, 77479, United States

RECRUITING

Pantheon Clinical Research

Bountiful, Utah, 84010, United States

RECRUITING

Alliance for Multispecialty Research Layton Research Center

Layton, Utah, 84041, United States

RECRUITING

Chrysalis Clinical Research, LLC

St. George, Utah, 84770, United States

RECRUITING

Washington Center for Weight Management and Research, Inc

Arlington, Virginia, 22206, United States

RECRUITING

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

RECRUITING

Selma Medical Associates

Winchester, Virginia, 22601, United States

RECRUITING

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226, United States

RECRUITING

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

RECRUITING

Novatrials

Charlestown, New South Wales, 2290, Australia

RECRUITING

Canopy Clinical Sutherland

Miranda, New South Wales, 2228, Australia

RECRUITING

Canopy Clinical Wollongong

Wollongong, New South Wales, 2500, Australia

RECRUITING

Fusion Clinical Research

Norwood, South Australia, 5067, Australia

RECRUITING

Emeritus Research Camberwell

Camberwell, Victoria, 3124, Australia

RECRUITING

Canopy Clinical Altona North

North Altona, Victoria, 3025, Australia

RECRUITING

Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

Yokohama, Kanagawa, 231-0023, Japan

RECRUITING

Doujin Memorial Foundation, Meiwa Hospital

Chiyoda-ku, Tokyo, 101-0041, Japan

RECRUITING

Tokyo Asbo Clinic

Chuo-ku, Tokyo, 104-0031, Japan

RECRUITING

Medical Corp Seikoukai New Medical Research System Clinic

Hachioji-shi, Tokyo, 192-0046, Japan

RECRUITING

Medical Corporation AOT Shinagawa Strings Clinic

Minato-ku, Tokyo, 108-0075, Japan

RECRUITING

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 160-0004, Japan

RECRUITING

Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic

Suginami-ku, Tokyo, 166-0003, Japan

RECRUITING

Ponce Medical School Foundation Inc

Ponce, 00716, Puerto Rico

RECRUITING

Puerto Rico Medical Research Inc.

Ponce, 00717, Puerto Rico

RECRUITING

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): December 26, 2027
• Study Completion (Estimated): March 19, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (70); AU (7); JP (7); PR (3)