NCT07684144 · Amgen
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
What this study is about
The primary objective of this trial is to evaluate the long-term effectiveness, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).
View original scientific description
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).
Interventions
DRUG
Maridebart Cafraglutide
Administered subcutaneously.
DRUG
Placebo
Administered subcutaneously.
Primary outcome measures
Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
Time frame: 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)
Time frame: Baseline of current trial up to 60 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Gilbert, Arizona
- Canoga Park, California
- Cerritos, California
- Chula Vista, California
- Pomona, California
- Miami, Florida
- Miami Lakes, Florida
- Orlando, Florida
- Weston, Florida
- Winter Park, Florida
- West Des Moines, Iowa
- Newton, Kansas
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations