RecruitingRecruiting
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
NCT07684144 · Amgen
In plain English
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Official title
A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus
About this study
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
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
Enrollment target: 950 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-07-29
Estimated completion: 2028-03-19
Last updated: 2026-09-03
Interventions
Drug: Maridebart CafraglutideDrug: Placebo
Primary outcomes
- • Percent Change in Body Weight from Baseline of the Parent Trial (20210184) (Baseline of parent trial (20210184) 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)
Sponsor
Amgen · industry
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (37)
Gilbert Center for Family MedicineRecruiting
Gilbert, Arizona, United States
San Fernando Valley Health InstituteRecruiting
Canoga Park, California, United States
Core Healthcare GroupRecruiting
Cerritos, California, United States
Velocity Clinical Research Chula VistaRecruiting
Chula Vista, California, United States
Empire Clinical ResearchRecruiting
Pomona, California, United States
Optimus U CorporationRecruiting
Miami, Florida, United States
San Marcus Research Clinic IncRecruiting
Miami Lakes, Florida, United States
Indago Research and Health CenterRecruiting
Miami Lakes, Florida, United States
Florida Institute for Clinical ResearchRecruiting
Orlando, Florida, United States
Encore Medical Research of Weston LLCRecruiting
Weston, Florida, United States
Conquest Research - Winter ParkRecruiting
Winter Park, Florida, United States
Iowa Diabetes ResearchRecruiting
West Des Moines, Iowa, United States
Alliance for Multispecialty Research NewtonRecruiting
Newton, Kansas, United States
Alliance for Multispecialty Research LLCRecruiting
Wichita, Kansas, United States
Alliance for Multispecialty Research - Kansas CityRecruiting
Kansas City, Missouri, United States
Palm Research Center IncRecruiting
Las Vegas, Nevada, United States
Premier ResearchRecruiting
Trenton, New Jersey, United States
West Clinical ResearchRecruiting
Morehead City, North Carolina, United States
Velocity Clinical Research - CincinnatiRecruiting
Cincinnati, Ohio, United States
Velocity Clinical Research - SpringdaleRecruiting
Cincinnati, Ohio, United States
Velocity Clinical Research - ProvidenceRecruiting
East Greenwich, Rhode Island, United States
Elligo Clinical Research CenterRecruiting
Austin, Texas, United States
Johnson County Clinical Trials Juno BellaireRecruiting
Bellaire, Texas, United States
Osvaldo A Brusco MD PARecruiting
Corpus Christi, Texas, United States
Soma Clinical Trials, LLCRecruiting
Denison, Texas, United States
JCCT- Juno Northwest HoustonRecruiting
Houston, Texas, United States
Manassas Clinical Research Center IncRecruiting
Manassas, Virginia, United States
Mikannohana Clinic, Diabetes, Endocrinology and MetabolismRecruiting
Matsuyama, Ehime, Japan
Morizono Medical ClinicRecruiting
Kitakyusyu-shi, Fukuoka, Japan
Nakamoto Medical ClinicRecruiting
Mito, Ibaraki, Japan
Nakakinen ClinicRecruiting
Naka, Ibaraki, Japan
Ohishi Naika ClinicRecruiting
Tsuchiura-shi, Ibaraki, Japan
Morinaga Ueno ClinicRecruiting
Kumamoto, Kumamoto, Japan
Shiraiwa Medical ClinicRecruiting
Kashiwara-shi, Osaka, Japan
Suruga ClinicRecruiting
Shizuoka, Shizuoka, Japan
Medical Corporation Ouitsukai Kanno NaikaRecruiting
Mitaka-shi, Tokyo, Japan
Latin Clinical Trial CenterRecruiting
San Juan, Puerto Rico