Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-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 and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

Conditions

  • Obesity
  • Overweight
  • Diabetes Mellitus, Type 2

Eligibility

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

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 (20210184 [NCT06858878]) 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 8 weeks (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
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

Gilbert Center for Family Medicine
Gilbert, Arizona 85296

San Fernando Valley Health Institute
Canoga Park, California 91304

Core Healthcare Group
Cerritos, California 90703

Velocity Clinical Research Chula Vista
Chula Vista, California 91911

Empire Clinical Research
Pomona, California 91767

Optimus U Corporation
Miami, Florida 33135

San Marcus Research Clinic Inc
Miami Lakes, Florida 33014

Indago Research and Health Center
Miami Lakes, Florida 33016

Florida Institute for Clinical Research
Orlando, Florida 32825

Encore Medical Research of Weston LLC
Weston, Florida 33331

Conquest Research - Winter Park
Winter Park, Florida 32789

Iowa Diabetes Research
West Des Moines, Iowa 50266

Alliance for Multispecialty Research Newton
Newton, Kansas 67114

Alliance for Multispecialty Research LLC
Wichita, Kansas 67226

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

Palm Research Center Inc
Las Vegas, Nevada 89128

Premier Research
Trenton, New Jersey 08611

West Clinical Research
Morehead City, North Carolina 28557

Velocity Clinical Research - Cincinnati
Cincinnati, Ohio 45242

Velocity Clinical Research - Springdale
Cincinnati, Ohio 45246

Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818

Elligo Clinical Research Center
Austin, Texas 78704

Johnson County Clinical Trials Juno Bellaire
Bellaire, Texas 77401

Manassas Clinical Research Center Inc
Manassas, Virginia 20110

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

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