Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
Recruiting · NCT07684235 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
Maridebart cafraglutidePlacebo
What this trial is about
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
- Randomized 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
Exclusion criteria
- 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 situ.
- 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) 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 it is running
60 locations listed across 27 US states.
- Pinnacle Research Group LLC - Anniston, Alabama, United States
- Alliance For Multispecialty Research - Daphne - Daphne, Alabama, United States
- Alliance for Multispecialty Research Mobile - Mobile, Alabama, United States
- Ark Clinical Research- Tustin - Fountain Valley, California, United States
- Long Beach Clinical Trials Services Inc - Long Beach, California, United States
- Ark Clinical Research- Long Beach - Long Beach, California, United States
- Catalina Research Institute - Montclair, California, United States
- Artemis Institute for Clinical Research - Riverside, California, United States
- Apex Clinical Research - San Diego, California, United States
- Artemis Institute for Clinical Research - San Diego, California, United States
- Southern California Clinical Research - Santa Ana, California, United States
- Diablo Clinical Research - Walnut Creek, California, United States
- Chase Medical Research LLC - Waterbury, Connecticut, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- Clinical Neuroscience Solutions - Jacksonville - Jacksonville, Florida, United States
- South Florida Wellness and Clinical Research Institute - Margate, Florida, United States
- Optimus U Corporation - Miami, Florida, United States
- Research Institute of South Florida - Miami, Florida, United States
- Indago Research and Health Center - Miami Lakes, Florida, United States
- Renstar Medical Research - Ocala, Florida, United States
- Clinical Neuroscience Solutions - Orlando - Orlando, Florida, United States
- Combined Research Orlando Phase I IV - Orlando, Florida, United States
- Florida Institute for Clinical Research - Orlando, Florida, United States
- Encore Medical Research of Weston LLC - Weston, Florida, United States
- Center for Advanced Research and Education - Gainesville, Georgia, United States
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group - Union City, Georgia, United States
- East-West Medical Research - Honolulu, Hawaii, United States
- Solaris Clinical Research - Meridian, Idaho, United States
- Flourish Research - Great Lakes Clinical Trials - Chicago, Illinois, United States
- Endeavor Health - Skokie, Illinois, United States
- Evanston Premier Healthcare Research LLC - Skokie, Illinois, United States
- Alliance for Multispecialty Research Newton - Newton, Kansas, United States
- Monroe Biomedical Research - Louisville, Kentucky, United States
- Velocity Clinical Research - Baton Rouge - Baton Rouge, Louisiana, United States
- Tandem Clinical Research - Marrero - Marrero, Louisiana, United States
- Headlands Research - Detroit - Southfield, Michigan, United States
- Prime Health and Wellness Sky Clinical Research Network Group - Fayette, Mississippi, United States
- Alliance for Multispecialty Research - Kansas City - Kansas City, Missouri, United States
- Palm Research Center Inc - Las Vegas, Nevada, United States
- Vector Clinical Trials - Las Vegas, Nevada, United States
- Velocity Clinical Research- Binghamton - Binghamton, New York, United States
- Rochester Clinical Research - Rochester, New York, United States
- Accellacare of Hickory - Hickory, North Carolina, United States
- Carolina Research Center Inc - Shelby, North Carolina, United States
- Clinical Trial Investigator Clinical Research Center - Cincinnati, Ohio, United States
- Velocity Clinical Research - Cincinnati - Cincinnati, Ohio, United States
- Alliance for Multispecialty Research - Norman - Norman, Oklahoma, United States
- Capital Area Research LLC - Newport, Pennsylvania, United States
- Velocity Clinical Research - Providence - East Greenwich, Rhode Island, United States
- Tribe Clinical Research LLC Dba Mountain View Clinical Research - Greenville, South Carolina, United States
- New Phase Research and Development - Knoxville, Tennessee, United States
- Elligo Clinical Research Center - Austin, Texas, United States
- Johnson County Clinical Trials Juno Bellaire - Bellaire, Texas, United States
- Cedar Health Research, LLC - Dallas, Texas, United States
- Epic Medical Research - Red Oak - DeSoto, Texas, United States
- Great Lakes Research Institute El Paso Research - El Paso, Texas, United States
- Cedar Health Research, LLC - Euless, Texas, United States
- JCCT- Juno Northwest Houston - Houston, Texas, United States
- Biopharma Informatic, LLC - Houston, Texas, United States
- Southern Endocrinology Associates PA - Mesquite, Texas, United States
Showing 60 of 87 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →