Obesity study: Maridebart cafraglutide
Official title Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
ClinicalTrials.gov ID: NCT07684235
What this study is testing
What is Maridebart cafraglutide?
An investigational subcutaneous injectable medicine being studied as a potential treatment for obesity.
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
- To see how well the drug works over time and whether it stays safe and tolerable.
- Who it's for
- Adults who are classified as obese or overweight.
- 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) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Completed the parent trial (2010181)
- Completed week 72 visit in parent trial
- Did not permanently discontinue trial intervention in parent trial
- assigned by chance within 7 Days of week 72 visit in the parent trial
You likely can't join if
- Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
- Body mass index ≤ 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 parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast...
- Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative(s)) history of...
See the full eligibility criteria
- Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Completed the parent trial (2010181)
- Completed week 72 visit in parent trial
- Did not permanently discontinue trial intervention in parent trial
- assigned by chance within 7 Days of week 72 visit in the parent trial
- Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention
- Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
- Body mass index ≤ 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 parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in...
- Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative(s)) history of medullary thyroid cancer.
- Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization
- Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from 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, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial)...
- 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
- Anniston, Alabama, United States
- Daphne, Alabama, United States
- Mobile, Alabama, United States
- Fountain Valley, California, United States
- Long Beach, California, United States
- Montclair, California, United States
- Riverside, California, United States
- San Diego, California, United States
- Santa Ana, California, United States
- Walnut Creek, California, United States
- Waterbury, Connecticut, United States
- Jacksonville, Florida, United States
- Lauderhill, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Weston, Florida, United States
- Gainesville, Georgia, United States
- Union City, Georgia, United States
+ 59 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 Anniston, Alabama, United States; Daphne, Alabama, United States; Mobile, Alabama, United States; Fountain Valley, California, United States; Long Beach, California, United States; Montclair, California, United States and 73 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.