Maridebart Cafraglutide for Type 2 Diabetes and Obesity
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Recruiting
Phase 3Interventional Study
ObesityOverweightDiabetes Mellitus, Type 2
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
950 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
This trial is looking for people with obesity and type 2 diabetes who have completed a previous study. Participants will take a medication to see how it works over a longer time period, while following specific rules during the trial.
Are You a Good Fit for This Trial?
Rules you outMalignancyMultiple endocrine neoplasia syndrome type 2
You may be able to join if
I have completed the Week 72 visit in a previous study.
I have signed the informed consent form.
I will use birth control during the trial and for 16 weeks after it ends.
I did not stop taking the study medication in the previous study.
I was randomized within 7 days of the Week 72 visit in the previous study.
You may not be able to join if
I have had surgery planned for obesity during the trial.
I have a body mass index (BMI) of 18.5 or less.
I am currently pregnant or breastfeeding.
I have a history of any malignancy diagnosed during the last study, except nonmelanoma skin cancers.
I have any clinically significant disorder that might risk my safety.
I have had thoughts of suicide or suicide behavior.
I am unable to complete all required procedures as judged by my doctor.
I have a known sensitivity to the treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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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 perma…
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).
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