Clinical trial

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

Recruiting now · Phase 3 · 4 countries · Registry ID NCT07684235

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 or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

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

Full registry criteria

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).

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 (20210181)Baseline of parent trial (20210181) 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

87 locations were listed when this page was built. The first 40 are shown.

Emeritus Research Sydney🇦🇺 Botany, New South Wales, Australia
Emeritus Research Camberwell🇦🇺 Camberwell, Victoria, Australia
Novatrials🇦🇺 Charlestown, New South Wales, Australia
Canopy Clinical Sutherland🇦🇺 Miranda, New South Wales, Australia
Canopy Clinical Altona North🇦🇺 North Altona, Victoria, Australia
Fusion Clinical Research🇦🇺 Norwood, South Australia, Australia
Canopy Clinical Wollongong🇦🇺 Wollongong, New South Wales, Australia
Doujin Memorial Foundation, Meiwa Hospital🇯🇵 Chiyoda-ku, Tokyo, Japan
Tokyo Asbo Clinic🇯🇵 Chuo-ku, Tokyo, Japan
Medical Corp Seikoukai New Medical Research System Clinic🇯🇵 Hachioji-shi, Tokyo, Japan
Medical Corporation AOT Shinagawa Strings Clinic🇯🇵 Minato-ku, Tokyo, Japan
Clinical Research Hospital Tokyo🇯🇵 Shinjuku-ku, Tokyo, Japan
Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic🇯🇵 Suginami-ku, Tokyo, Japan
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic🇯🇵 Yokohama, Kanagawa, Japan
Ponce Medical School Foundation Inc🇵🇷 Ponce, Puerto Rico
Puerto Rico Medical Research Inc.🇵🇷 Ponce, Puerto Rico
Latin Clinical Trial Center🇵🇷 San Juan, Puerto Rico
Pinnacle Research Group LLC🇺🇸 Anniston, Alabama, United States
Washington Center for Weight Management and Research, Inc🇺🇸 Arlington, Virginia, United States
Elligo Clinical Research Center🇺🇸 Austin, Texas, United States
Velocity Clinical Research - Baton Rouge🇺🇸 Baton Rouge, Louisiana, United States
Johnson County Clinical Trials Juno Bellaire🇺🇸 Bellaire, Texas, United States
Velocity Clinical Research- Binghamton🇺🇸 Binghamton, New York, United States
Pantheon Clinical Research🇺🇸 Bountiful, Utah, United States
Flourish Research - Great Lakes Clinical Trials🇺🇸 Chicago, Illinois, United States
Clinical Trial Investigator Clinical Research Center🇺🇸 Cincinnati, Ohio, United States
Velocity Clinical Research - Cincinnati🇺🇸 Cincinnati, Ohio, United States
Cedar Health Research, LLC🇺🇸 Dallas, Texas, United States
Alliance For Multispecialty Research - Daphne🇺🇸 Daphne, Alabama, United States
Epic Medical Research - Red Oak🇺🇸 DeSoto, Texas, United States
Velocity Clinical Research - Providence🇺🇸 East Greenwich, Rhode Island, United States
Great Lakes Research Institute El Paso Research🇺🇸 El Paso, Texas, United States
Cedar Health Research, LLC🇺🇸 Euless, Texas, United States
Prime Health and Wellness Sky Clinical Research Network Group🇺🇸 Fayette, Mississippi, United States
Ark Clinical Research- Tustin🇺🇸 Fountain Valley, California, United States
Center for Advanced Research and Education🇺🇸 Gainesville, Georgia, United States
Tribe Clinical Research LLC Dba Mountain View Clinical Research🇺🇸 Greenville, South Carolina, United States
Accellacare of Hickory🇺🇸 Hickory, North Carolina, United States
East-West Medical Research🇺🇸 Honolulu, Hawaii, United States
Biopharma Informatic, LLC🇺🇸 Houston, Texas, United States