NCT07684235RecruitingPhase 3
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 3200 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 23 Jul 2026
- Primary completion date
- 26 Dec 2027
- Lead sponsor
- Amgen
- Diseases
- Obesity
- NCT number
- NCT07684235
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 3200
- From 23 Jul 2026 to the primary completion date, 26 Dec 2027
- 91 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
- 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.
- 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.
Other illness
- History of ischemic optic neuropathy
- Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer.
- 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.
Other
- 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
- 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.
- 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.
- Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (91)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fusion Clinical Research Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Emeritus Research Sydney Coordinator of this site? Confirm its status | Botany | Australia | Recruiting |
| Emeritus Research Camberwell Coordinator of this site? Confirm its status | Camberwell | Australia | Recruiting |
| Novatrials Coordinator of this site? Confirm its status | Charlestown | Australia | Recruiting |
| Logan Hospital Coordinator of this site? Confirm its status | Meadowbrook | Australia | Recruiting |
| Canopy Clinical Sutherland Coordinator of this site? Confirm its status | Miranda | Australia | Recruiting |
| Canopy Clinical Wollongong Coordinator of this site? Confirm its status | Miranda | Australia | Recruiting |
| Canopy Clinical Altona North Coordinator of this site? Confirm its status | North Altona | Australia | Recruiting |
| Ecogene-21 Coordinator of this site? Confirm its status | Chicoutimi | Canada | Recruiting |
| Wharton Medical Clinic Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Curans Heart Center Coordinator of this site? Confirm its status | Thunder Bay | Canada | Recruiting |
| Doujin Memorial Foundation, Meiwa Hospital Coordinator of this site? Confirm its status | Chiyoda-ku | Japan | Recruiting |
| Tokyo Asbo Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Recruiting |
| Medical Corp Seikoukai New Medical Research System Clinic Coordinator of this site? Confirm its status | Hachioji-shi | Japan | Recruiting |
| Medical Corporation AOT Shinagawa Strings Clinic Coordinator of this site? Confirm its status | Minato-ku | Japan | Recruiting |
| Clinical Research Hospital Tokyo Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Recruiting |
| Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic Coordinator of this site? Confirm its status | Suginami-ku | Japan | Recruiting |
| Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Puerto Rico Medical Research Inc. Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Recruiting |
| Ponce Medical School Foundation Inc. Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Recruiting |
| Latin Clinical Trial Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Pinnacle Research Group, LLC Coordinator of this site? Confirm its status | Anniston | United States | Recruiting |
| Washington Center for Weight Management and Research, Inc Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| Elligo Clinical Research Center Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Velocity Clinical Research - Baton Rouge Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Johnson County Clinical Trials Juno Bellaire Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Velocity Clinical Research - Binghamton Coordinator of this site? Confirm its status | Binghamton | United States | Recruiting |
| Pantheon Clinical Research Coordinator of this site? Confirm its status | Bountiful | United States | Recruiting |
| Flourish Research - Great Lakes Clinical Trials Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Clinical Trial Investigator Clinical Research Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Velocity Clinical Research - Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Cedar Health Research, LLC Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Alliance For Multispecialty Research - Daphne Coordinator of this site? Confirm its status | Daphne | United States | Recruiting |
| Epic Medical Research - Red Oak Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| Velocity Clinical Research, Providence Coordinator of this site? Confirm its status | East Greenwich | United States | Recruiting |
| Great Lakes Research Institute El Paso Research Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| Prime Health and Wellness Sky Clinical Research Network Group Coordinator of this site? Confirm its status | Fayette | United States | Recruiting |
| Ark Clinical Research- Tustin Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| Center for Advanced Research and Education Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Tribe Clinical Research LLC DBA Mountain View Clinical Research Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Accellacare of Hickory Coordinator of this site? Confirm its status | Hickory | United States | Recruiting |
| East-West Medical Research Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Clinical Neuroscience Solutions - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Alliance for Multispecialty Research - Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| New Phase Research And Development Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Accellacare US Inc., d/b/a Accellacare of Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Vector Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Palm Research Center Inc Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| South Florida Wellness and Clinical Research Institute Coordinator of this site? Confirm its status | Lauderhill | United States | Recruiting |
| Alliance for Multispecialty Research Layton Research Center Coordinator of this site? Confirm its status | Layton | United States | Recruiting |
| JCCT- Juno Northwest Houston Coordinator of this site? Confirm its status | Lenexa | United States | Recruiting |
| Long Beach Clinical Trials Services, Inc Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Ark Clinical Research - Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Louisville Metabolic and Atherosclerosis Research Center Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Tandem Clinical Research - Marrero Coordinator of this site? Confirm its status | Marrero | United States | Recruiting |
| Solaris Clinical Research Coordinator of this site? Confirm its status | Meridian | United States | Recruiting |
| Southern Endocrinology Associates PA Coordinator of this site? Confirm its status | Mesquite | United States | Recruiting |
| Research Institute of South Florida Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Optimus U Corporation Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Indago Research and Health Center Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Alliance for Multispecialty Research Mobile Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| Catalina Research Institute Coordinator of this site? Confirm its status | Montclair | United States | Recruiting |
| Capital Area Research LLC Coordinator of this site? Confirm its status | Newport | United States | Recruiting |
| Health Research of Hampton Roads Coordinator of this site? Confirm its status | Newport News | United States | Recruiting |
| Alliance for Multispecialty Research Newton Coordinator of this site? Confirm its status | Newton | United States | Recruiting |
| Alliance for Multispecialty Research - Norman Coordinator of this site? Confirm its status | Norman | United States | Recruiting |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| Combined Research Orlando Phase I-IV Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Florida Institute for Clinical Research Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Clinical Neuroscience Solutions - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Great Lakes Research Institute - McAllen Research Coordinator of this site? Confirm its status | Pharr | United States | Recruiting |
| Artemis Institute for Clinical Research Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| Rochester Clinical Research Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Clinical Trials of Texas Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Apex Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Artemis Institute for Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Southern California Clinical Research Coordinator of this site? Confirm its status | Santa Ana | United States | Recruiting |
| Carolina Research Center, Inc Coordinator of this site? Confirm its status | Shelby | United States | Recruiting |
| Evanston Premier Healthcare Research, LLC Coordinator of this site? Confirm its status | Skokie | United States | Recruiting |
| Endeavor Health Coordinator of this site? Confirm its status | Skokie | United States | Recruiting |
| Headlands Research - Detroit Coordinator of this site? Confirm its status | Southfield | United States | Recruiting |
| Chrysalis Clinical Research, LLC Coordinator of this site? Confirm its status | St. George | United States | Recruiting |
| Sugar Lakes Family Practice Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group Coordinator of this site? Confirm its status | Union City | United States | Recruiting |
| Diablo Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Chase Medical Research, LLC Coordinator of this site? Confirm its status | Waterbury | United States | Recruiting |
| Allegiance Research Specialists Coordinator of this site? Confirm its status | Wauwatosa | United States | Recruiting |
| Encore Medical Research of Weston, LLC Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
| Selma Medical Associates Coordinator of this site? Confirm its status | Winchester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.