Clinical trial
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Recruiting now · Phase 3 · 3 countries · Registry ID NCT07684144
Recruiting nowPhase 3Interventional
What this 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).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight, Diabetes Mellitus, Type 2
Full registry 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).
Treatments and study arms
Maridebart Cafraglutide
Drug
Administered subcutaneously.
Placebo
Drug
Administered subcutaneously.
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
Study locations
37 locations were listed when this page was built. The first 40 are shown.
Shiraiwa Medical Clinic🇯🇵 Kashiwara-shi, Osaka, Japan
Morizono Medical Clinic🇯🇵 Kitakyusyu-shi, Fukuoka, Japan
Morinaga Ueno Clinic🇯🇵 Kumamoto, Kumamoto, Japan
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism🇯🇵 Matsuyama, Ehime, Japan
Medical Corporation Ouitsukai Kanno Naika🇯🇵 Mitaka-shi, Tokyo, Japan
Nakamoto Medical Clinic🇯🇵 Mito, Ibaraki, Japan
Nakakinen Clinic🇯🇵 Naka, Ibaraki, Japan
Suruga Clinic🇯🇵 Shizuoka, Shizuoka, Japan
Ohishi Naika Clinic🇯🇵 Tsuchiura-shi, Ibaraki, Japan
Latin Clinical Trial Center🇵🇷 San Juan, Puerto Rico
Elligo Clinical Research Center🇺🇸 Austin, Texas, United States
Johnson County Clinical Trials Juno Bellaire🇺🇸 Bellaire, Texas, United States
San Fernando Valley Health Institute🇺🇸 Canoga Park, California, United States
Core Healthcare Group🇺🇸 Cerritos, California, United States
Velocity Clinical Research Chula Vista🇺🇸 Chula Vista, California, United States
Velocity Clinical Research - Cincinnati🇺🇸 Cincinnati, Ohio, United States
Velocity Clinical Research - Springdale🇺🇸 Cincinnati, Ohio, United States
Osvaldo A Brusco MD PA🇺🇸 Corpus Christi, Texas, United States
Soma Clinical Trials, LLC🇺🇸 Denison, Texas, United States
Velocity Clinical Research - Providence🇺🇸 East Greenwich, Rhode Island, United States
Gilbert Center for Family Medicine🇺🇸 Gilbert, Arizona, United States
JCCT- Juno Northwest Houston🇺🇸 Houston, Texas, United States
Alliance for Multispecialty Research - Kansas City🇺🇸 Kansas City, Missouri, United States
Palm Research Center Inc🇺🇸 Las Vegas, Nevada, United States
Manassas Clinical Research Center Inc🇺🇸 Manassas, Virginia, United States
Optimus U Corporation🇺🇸 Miami, Florida, United States
Indago Research and Health Center🇺🇸 Miami Lakes, Florida, United States
San Marcus Research Clinic Inc🇺🇸 Miami Lakes, Florida, United States
West Clinical Research🇺🇸 Morehead City, North Carolina, United States
Alliance for Multispecialty Research Newton🇺🇸 Newton, Kansas, United States
Florida Institute for Clinical Research🇺🇸 Orlando, Florida, United States
Empire Clinical Research🇺🇸 Pomona, California, United States
Premier Research🇺🇸 Trenton, New Jersey, United States
Iowa Diabetes Research🇺🇸 West Des Moines, Iowa, United States
Encore Medical Research of Weston LLC🇺🇸 Weston, Florida, United States
Alliance for Multispecialty Research LLC🇺🇸 Wichita, Kansas, United States
Conquest Research - Winter Park🇺🇸 Winter Park, Florida, United States