NCT07684144 Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
| NCT ID | NCT07684144 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amgen |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 950 participants |
| Start Date | 2026-07-29 |
| Primary Completion | 2027-12-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 950 participants in total. It began in 2026-07-29 with a primary completion date of 2027-12-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT07684144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07684144 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 950 participants.
Is NCT07684144 currently recruiting?
Yes, NCT07684144 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT07684144 trial being conducted?
This trial is being conducted at Gilbert, United States, Canoga Park, United States, Cerritos, United States, La Mesa, United States and 11 additional locations.
Who is sponsoring the NCT07684144 clinical trial?
NCT07684144 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 950 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.