Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Recruiting · NCT07684144 · 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 and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).
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) 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 it is running
60 locations listed across 13 US states.
- Gilbert Center for Family Medicine - Gilbert, Arizona, United States
- Gilbert Center for Family Medicine - Gilbert, Arizona, United States
- San Fernando Valley Health Institute - Canoga Park, California, United States
- San Fernando Valley Health Institute - Canoga Park, California, United States
- Core Healthcare Group - Cerritos, California, United States
- Core Healthcare Group - Cerritos, California, United States
- Velocity Clinical Research Chula Vista - Chula Vista, California, United States
- Velocity Clinical Research Chula Vista - Chula Vista, California, United States
- Empire Clinical Research - Pomona, California, United States
- Empire Clinical Research - Pomona, California, United States
- Optimus U Corporation - Miami, Florida, United States
- Optimus U Corporation - Miami, Florida, United States
- San Marcus Research Clinic Inc - Miami Lakes, Florida, United States
- Indago Research and Health Center - Miami Lakes, Florida, United States
- San Marcus Research Clinic Inc - Miami Lakes, Florida, United States
- Indago Research and Health Center - Miami Lakes, Florida, United States
- Florida Institute for Clinical Research - Orlando, Florida, United States
- Florida Institute for Clinical Research - Orlando, Florida, United States
- Encore Medical Research of Weston LLC - Weston, Florida, United States
- Encore Medical Research of Weston LLC - Weston, Florida, United States
- Conquest Research - Winter Park - Winter Park, Florida, United States
- Conquest Research - Winter Park - Winter Park, Florida, United States
- Iowa Diabetes Research - West Des Moines, Iowa, United States
- Iowa Diabetes Research - West Des Moines, Iowa, United States
- Alliance for Multispecialty Research Newton - Newton, Kansas, United States
- Alliance for Multispecialty Research Newton - Newton, Kansas, United States
- Alliance for Multispecialty Research LLC - Wichita, Kansas, United States
- Alliance for Multispecialty Research LLC - Wichita, Kansas, United States
- Alliance for Multispecialty Research - Kansas City - Kansas City, Missouri, United States
- Alliance for Multispecialty Research - Kansas City - Kansas City, Missouri, United States
- Palm Research Center Inc - Las Vegas, Nevada, United States
- Palm Research Center Inc - Las Vegas, Nevada, United States
- Premier Research - Trenton, New Jersey, United States
- Premier Research - Trenton, New Jersey, United States
- West Clinical Research - Morehead City, North Carolina, United States
- West Clinical Research - Morehead City, North Carolina, United States
- Velocity Clinical Research - Cincinnati - Cincinnati, Ohio, United States
- Velocity Clinical Research - Springdale - Cincinnati, Ohio, United States
- Velocity Clinical Research - Cincinnati - Cincinnati, Ohio, United States
- Velocity Clinical Research - Springdale - Cincinnati, Ohio, United States
- Velocity Clinical Research - Providence - East Greenwich, Rhode Island, United States
- Velocity Clinical Research - Providence - East Greenwich, Rhode Island, United States
- Elligo Clinical Research Center - Austin, Texas, United States
- Elligo Clinical Research Center - Austin, Texas, United States
- Johnson County Clinical Trials Juno Bellaire - Bellaire, Texas, United States
- Johnson County Clinical Trials Juno Bellaire - Bellaire, Texas, United States
- Osvaldo A Brusco MD PA - Corpus Christi, Texas, United States
- Osvaldo A Brusco MD PA - Corpus Christi, Texas, United States
- Soma Clinical Trials, LLC - Denison, Texas, United States
- Soma Clinical Trials, LLC - Denison, Texas, United States
- JCCT- Juno Northwest Houston - Houston, Texas, United States
- JCCT- Juno Northwest Houston - Houston, Texas, United States
- Manassas Clinical Research Center Inc - Manassas, Virginia, United States
- Manassas Clinical Research Center Inc - Manassas, Virginia, United States
- Latin Clinical Trial Center - San Juan, Puerto Rico
- Latin Clinical Trial Center - San Juan, Puerto Rico
- Mikannohana Clinic, Diabetes, Endocrinology and Metabolism - Matsuyama, Ehime, Japan
- Mikannohana Clinic, Diabetes, Endocrinology and Metabolism - Matsuyama, Ehime, Japan
- Morizono Medical Clinic - Kitakyusyu-shi, Fukuoka, Japan
- Morizono Medical Clinic - Kitakyusyu-shi, Fukuoka, Japan
Showing 60 of 74 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →