Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafrag… (NCT07684144) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
950 participantsStarted 2026-07-29
Plain-language 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).
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 extension trial that measures long-term safety and weight changes, and it's not yet recruiting — how much longer do you think it will be before it opens, and would it make sense for me to wait for it or pursue treatment now?
2Since this trial is an extension of a parent trial called MARITIME-2-EXTENSION, does that mean I would need to have already participated in the original study to be eligible, and if so, is that parent trial still an option for me?
3The trial is tracking serious adverse events over the long term — based on what's already known about maridebart cafraglutide from earlier studies, what kinds of side effects or safety concerns should I be aware of before considering this drug?
4This trial measures percent change in body weight starting from the baseline of the parent trial, not from my current weight — how does that affect how we would interpret results for someone like me who hasn't been in the earlier study?
5Given that I have both obesity and type 2 diabetes, are there already approved medications or standard treatments that might be a better starting point compared to waiting for a not-yet-recruiting trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
Timeframe: Baseline of parent trial (20210184) to Week 48 of current trial
2
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Baseline of current trial up to 60 weeks