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

Purpose

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

  • Obesity
  • Overweight

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts 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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Maridebart Cafraglutide Low Dose Q4W 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide Medium Dose Q4W 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide Medium Dose Q8W 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide
Placebo Comparator
Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial) 		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
    Administered subcutaneously.
Experimental
Maridebart Cafraglutide High Dose Q4W 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide High Dose Q8W 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide High Dose Q12W 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide
Placebo Comparator
Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial) 		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
    Administered subcutaneously.
Experimental
Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial) 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial) 		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
    Administered subcutaneously
    Other names:
    • AMG 133
    • MariTide

Recruiting Locations

Pinnacle Research Group LLC
Anniston, Alabama 36207

Alliance For Multispecialty Research - Daphne
Daphne, Alabama 36526

Alliance for Multispecialty Research Mobile
Mobile, Alabama 36608

Ark Clinical Research- Tustin
Fountain Valley, California 92708

Long Beach Clinical Trials Services Inc
Long Beach, California 90806

Ark Clinical Research- Long Beach
Long Beach, California 90815

Catalina Research Institute
Montclair, California 91763

Artemis Institute for Clinical Research
Riverside, California 92503

Apex Clinical Research
San Diego, California 92120

Artemis Institute for Clinical Research
San Diego, California 92123

Southern California Clinical Research
Santa Ana, California 92701

Diablo Clinical Research
Walnut Creek, California 94598

Chase Medical Research LLC
Waterbury, Connecticut 06708

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216

Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida 32256

South Florida Wellness and Clinical Research Institute
Margate, Florida 33063

Optimus U Corporation
Miami, Florida 33135

Research Institute of South Florida
Miami, Florida 33173

Indago Research and Health Center
Miami Lakes, Florida 33016

Renstar Medical Research
Ocala, Florida 34470

Clinical Neuroscience Solutions - Orlando
Orlando, Florida 32801

Combined Research Orlando Phase I IV
Orlando, Florida 32807

Florida Institute for Clinical Research
Orlando, Florida 32825

Encore Medical Research of Weston LLC
Weston, Florida 33331

Center for Advanced Research and Education
Gainesville, Georgia 30501

Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia 30291

East-West Medical Research
Honolulu, Hawaii 96814

Solaris Clinical Research
Meridian, Idaho 83646

Flourish Research - Great Lakes Clinical Trials
Chicago, Illinois 60640

Evanston Premier Healthcare Research LLC
Skokie, Illinois 60077

Alliance for Multispecialty Research Newton
Newton, Kansas 67114

Monroe Biomedical Research
Louisville, Kentucky 40213

Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana 70809

Tandem Clinical Research - Marrero
Marrero, Louisiana 70072

Headlands Research - Detroit
Southfield, Michigan 48034

Prime Health and Wellness Sky Clinical Research Network Group
Fayette, Mississippi 39069

Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri 64114

Palm Research Center Inc
Las Vegas, Nevada 89128

Vector Clinical Trials
Las Vegas, Nevada 89128

Velocity Clinical Research- Binghamton
Binghamton, New York 13905

Rochester Clinical Research
Rochester, New York 14609

Accellacare of Hickory
Hickory, North Carolina 28601

Carolina Research Center Inc
Shelby, North Carolina 28150

Clinical Trial Investigator Clinical Research Center
Cincinnati, Ohio 45212

Velocity Clinical Research - Cincinnati
Cincinnati, Ohio 45219

Alliance for Multispecialty Research - Norman
Norman, Oklahoma 73069

Capital Area Research LLC
Newport, Pennsylvania 17074

Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818

Tribe Clinical Research LLC Dba Mountain View Clinical Research
Greenville, South Carolina 29607

New Phase Research and Development
Knoxville, Tennessee 37909

Elligo Clinical Research Center
Austin, Texas 78704

Johnson County Clinical Trials Juno Bellaire
Bellaire, Texas 77401

Cedar Health Research, LLC
Dallas, Texas 75251

Epic Medical Research - Red Oak
DeSoto, Texas 75115

Great Lakes Research Institute El Paso Research
El Paso, Texas 79936

Cedar Health Research, LLC
Euless, Texas 76040

JCCT- Juno Northwest Houston
Houston, Texas 77040

Biopharma Informatic, LLC
Houston, Texas 77043

Southern Endocrinology Associates PA
Mesquite, Texas 75149

Great Lakes Research Institute - McAllen Research
Pharr, Texas 78557

Clinical Trials of Texas
San Antonio, Texas 78229

Sugar Lakes Family Practice
Sugar Land, Texas 77479

Pantheon Clinical Research
Bountiful, Utah 84010

Alliance for Multispecialty Research Layton Research Center
Layton, Utah 84041

Chrysalis Clinical Research, LLC
St. George, Utah 84770

Washington Center for Weight Management and Research, Inc
Arlington, Virginia 22206

Health Research of Hampton Roads
Newport News, Virginia 23606

Allegiance Research Specialists
Wauwatosa, Wisconsin 53226

Ponce Medical School Foundation Inc
Ponce, Puerto Rico 00716

Puerto Rico Medical Research Inc.
Ponce, Puerto Rico 00717

Latin Clinical Trial Center
San Juan, Puerto Rico 00909

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com