Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Amgen · NCT07684144
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–99 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 950
- US sites recruiting
- 31
- Study start
- July 29, 2026
- Record last updated
- October 5, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Maridebart Cafraglutide; Placebo
Conditions: Obesity; Overweight; Diabetes Mellitus, Type 2
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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).
Recruiting US locations
Gilbert Center for Family Medicine
Gilbert, AZ 85296
San Fernando Valley Health Institute
Canoga Park, CA 91304
Core Healthcare Group
Cerritos, CA 90703
Velocity Clinical Research Chula Vista
La Mesa, CA 91942
Paradigm Clinical Research
Modesto, CA 95355
Empire Clinical Research
Pomona, CA 91767
San Marcus Research Clinic Inc
Miami, FL 33015
Optimus U Corporation
Miami, FL 33135
Indago Research and Health Center
Miami Lakes, FL 33016
Florida Institute for Clinical Research
Orlando, FL 32825
Encore Medical Research of Weston LLC
Weston, FL 33331
Conquest Research - Winter Park
Winter Park, FL 32789
Endeavor Health
Skokie, IL 60077
Iowa Diabetes Research
West Des Moines, IA 50266
JCCT- Juno Northwest Houston
Lenexa, KS 66219
Alliance for Multispecialty Research Newton
Newton, KS 67114
Alliance for Multispecialty Research LLC
Wichita, KS 67226
Ima Clinical Research- Monroe
Monroe, LA 71201
Annapolis Internal Medicine, LLC
Annapolis, MD 21401
Alliance for Multispecialty Research - Kansas City
Kansas City, MO 64114
Palm Research Center Inc
Las Vegas, NV 89148
Premier Research
Trenton, NJ 08611
West Clinical Research
Morehead City, NC 28557
Velocity Clinical Research - Cincinnati
Cincinnati, OH 45242
Velocity Clinical Research - Springdale
Cincinnati, OH 45246
Velocity Clinical Research - Providence
East Greenwich, RI 02818
Elligo Clinical Research Center
Austin, TX 78704
Johnson County Clinical Trials Juno Bellaire
Bellaire, TX 77401
Osvaldo A Brusco MD PA
Corpus Christi, TX 78414
Soma Clinical Trials, LLC
Denison, TX 75020
Manassas Clinical Research Center Inc
Burke, VA 22015
Study contacts (from the official record)
- Amgen Call Center · 866-572-6436 · medinfo@amgen.com
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