Obesity study: Maridebart Cafraglutide
Official title Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
ClinicalTrials.gov ID: NCT07684144
What this study is testing
What is Maridebart Cafraglutide?
An investigational once‑daily injectable medicine being studied for obesity and type 2 diabetes mellitus.
Also referred to as AMG 133, MariTide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether maridebart cafraglutide stays safe and helpful over a longer period for people with obesity and type 2 diabetes.
- Who it's for
- You may be able to join if you have obesity and type 2 diabetes and you finished a previous related study.
- What's involved
- You will keep taking maridebart cafraglutide as directed and attend follow‑up visits to check your health.
- Time commitment
- This extension lasts for the same length as the original study and includes the same scheduled visits.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
- Completed the Week 72 visit in Study 20210184.
- Did not permanently discontinue the investigational product in the parent trial (20210184).
- assigned by chance 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.
You likely can't join if
- 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.
- Nonmelanoma skin cancers
- Breast ductal carcinoma in situ
See the full eligibility criteria
- Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
- Completed the Week 72 visit in Study 20210184.
- Did not permanently discontinue the investigational product in the parent trial (20210184).
- assigned by chance 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.
- 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Canoga Park, California, United States
- Cerritos, California, United States
- La Mesa, California, United States
- Modesto, California, United States
- Pomona, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Weston, Florida, United States
- Winter Park, Florida, United States
- Skokie, Illinois, United States
- West Des Moines, Iowa, United States
- Lenexa, Kansas, United States
- Newton, Kansas, United States
- Wichita, Kansas, United States
- Monroe, Louisiana, United States
- Annapolis, Maryland, United States
- Kansas City, Missouri, United States
- Las Vegas, Nevada, United States
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Canoga Park, California, United States; Cerritos, California, United States; La Mesa, California, United States; Modesto, California, United States; Pomona, California, United States and 37 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.