Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 99 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well maridebart cafraglutide works over time, how safe it is, and how well people handle its side effects. It is for people with obesity or overweight who finished the earlier study and meet the rules to continue.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a consent form and agree to follow the study rules.
- Have finished the earlier study.
- Have completed the week 72 visit in that study.
- Did not permanently stop the study treatment in the earlier study.
- Be assigned to a treatment group within 7 days of the earlier study’s week 72 visit.
- Use the birth control required by the study during treatment and for 16 weeks after the last dose.
Who can't join
- Plan to have weight-loss surgery, a weight-loss procedure using a scope or device, or other major surgery during the study. Minor surgery may be allowed by the study doctor.
- Have a body mass index (BMI), a measure based on height and weight, of 18.5 or less; have a known sensitivity to a study product or ingredient; or have had damage to the eye’s nerve from poor blood flow.
- Had cancer diagnosed during the earlier study. Exceptions are certain skin cancers other than melanoma, or early breast, cervical, or prostate cancers that have not spread, treated with the aim of curing them.
- During the earlier study, were found to have MEN2, a condition that causes tumors in glands, or a parent, sibling, or child with medullary thyroid cancer, a type of thyroid cancer.
- At the week 72 visit, have a score of 15 or higher on the PHQ-9 depression survey, or report suicidal thoughts with intent to act or any suicidal behavior on the study’s suicide-risk survey.
- Are unlikely to finish the required study steps or follow its rules, or have another health condition that the study doctor thinks would make participation unsafe. This includes drug or alcohol abuse and eating disorders.
- Are pregnant or breastfeeding, or plan to become pregnant or breastfeed during treatment or within 16 weeks after the last dose.
- Work at the study site and are directly involved in the study, or are the spouse, parent, child, or sibling of someone who does.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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).
Study sites (71)
AL
- Pinnacle Research Group LLC · Anniston, AL 36207More trials in Anniston
- Alliance For Multispecialty Research - Daphne · Daphne, AL 36526More trials in Daphne
- Alliance for Multispecialty Research Mobile · Mobile, AL 36608More trials in Mobile
CA
- Ark Clinical Research- Tustin · Fountain Valley, CA 92708More trials in Fountain Valley
- Long Beach Clinical Trials Services Inc · Long Beach, CA 90806More trials in Long Beach
- Ark Clinical Research- Long Beach · Long Beach, CA 90815More trials in Long Beach
- Catalina Research Institute · Montclair, CA 91763More trials in Montclair
- Artemis Institute for Clinical Research · Riverside, CA 92503More trials in Riverside
- Artemis Institute for Clinical Research · San Diego, CA 92103More trials in San Diego
- Apex Clinical Research · San Diego, CA 92120More trials in San Diego
- Southern California Clinical Research · Santa Ana, CA 92701More trials in Santa Ana
- Diablo Clinical Research · Walnut Creek, CA 94598More trials in Walnut Creek
CT
- Chase Medical Research LLC · Waterbury, CT 06708More trials in Waterbury
FL
- Jacksonville Center for Clinical Research · Jacksonville, FL 32216More trials in Jacksonville
- Clinical Neuroscience Solutions - Jacksonville · Jacksonville, FL 32256More trials in Jacksonville
- South Florida Wellness and Clinical Research Institute · Lauderhill, FL 33351More trials in Lauderhill
- Optimus U Corporation · Miami, FL 33135More trials in Miami
- Research Institute of South Florida · Miami, FL 33173More trials in Miami
- Indago Research and Health Center · Miami Lakes, FL 33016More trials in Miami Lakes
- Renstar Medical Research · Ocala, FL 34470More trials in Ocala
- Clinical Neuroscience Solutions - Orlando · Orlando, FL 32801More trials in Orlando
- Combined Research Orlando Phase I IV · Orlando, FL 32807More trials in Orlando
- Florida Institute for Clinical Research · Orlando, FL 32825More trials in Orlando
- Encore Medical Research of Weston LLC · Weston, FL 33331More trials in Weston
GA
- Center for Advanced Research and Education · Gainesville, GA 30501More trials in Gainesville
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group · Union City, GA 30291More trials in Union City
HI
- East-West Medical Research · Honolulu, HI 96814More trials in Honolulu
ID
- Solaris Clinical Research · Meridian, ID 83646More trials in Meridian
IL
- Flourish Research - Great Lakes Clinical Trials · Chicago, IL 60640More trials in Chicago
- Endeavor Health · Skokie, IL 60077More trials in Skokie
- Evanston Premier Healthcare Research LLC · Skokie, IL 60077More trials in Skokie
KS
- JCCT- Juno Northwest Houston · Lenexa, KS 66219More trials in Lenexa
- Alliance for Multispecialty Research Newton · Newton, KS 67114More trials in Newton
KY
- Louisville Metabolic and Atherosclerosis Research Center · Louisville, KY 40213More trials in Louisville
LA
- Velocity Clinical Research - Baton Rouge · Baton Rouge, LA 70809More trials in Baton Rouge
- Tandem Clinical Research - Marrero · Marrero, LA 70072More trials in Marrero
MI
- Headlands Research - Detroit · Southfield, MI 48034More trials in Southfield
MO
- Alliance for Multispecialty Research - Kansas City · Kansas City, MO 64114More trials in Kansas City
MS
- Prime Health and Wellness Sky Clinical Research Network Group · Fayette, MS 39069More trials in Fayette
NC
- Accellacare of Hickory · Hickory, NC 28602More trials in Hickory
- Carolina Research Center Inc · Shelby, NC 28150More trials in Shelby
NV
- Vector Clinical Trials · Las Vegas, NV 89128More trials in Las Vegas
- Palm Research Center Inc · Las Vegas, NV 89148More trials in Las Vegas
NY
- Velocity Clinical Research- Binghamton · Binghamton, NY 13905More trials in Binghamton
- Rochester Clinical Research · Rochester, NY 14609More trials in Rochester
OH
- Clinical Trial Investigator Clinical Research Center · Cincinnati, OH 45212More trials in Cincinnati
- Velocity Clinical Research - Cincinnati · Cincinnati, OH 45219More trials in Cincinnati
OK
- Alliance for Multispecialty Research - Norman · Norman, OK 73069More trials in Norman
PA
- Capital Area Research LLC · Newport, PA 17074More trials in Newport
RI
- Velocity Clinical Research - Providence · East Greenwich, RI 02818More trials in East Greenwich
SC
- Tribe Clinical Research LLC Dba Mountain View Clinical Research · Greenville, SC 29607More trials in Greenville
TN
- New Phase Research and Development · Knoxville, TN 37909More trials in Knoxville
- Accellacare US Inc., d/b/a Accellacare of Knoxville · Knoxville, TN 37938More trials in Knoxville
TX
- Elligo Clinical Research Center · Austin, TX 78704More trials in Austin
- Johnson County Clinical Trials Juno Bellaire · Bellaire, TX 77401More trials in Bellaire
- Cedar Health Research, LLC · Dallas, TX 75235More trials in Dallas
- Cedar Health Research, LLC · Dallas, TX 75251More trials in Dallas
- Epic Medical Research - Red Oak · DeSoto, TX 75115More trials in DeSoto
- Great Lakes Research Institute El Paso Research · El Paso, TX 79905More trials in El Paso
- Biopharma Informatic, LLC · Houston, TX 77043More trials in Houston
- Southern Endocrinology Associates PA · Mesquite, TX 75149More trials in Mesquite
- Great Lakes Research Institute - McAllen Research · Pharr, TX 78557More trials in Pharr
- Clinical Trials of Texas · San Antonio, TX 78229More trials in San Antonio
- Sugar Lakes Family Practice · Sugar Land, TX 77479More trials in Sugar Land
UT
- Pantheon Clinical Research · Bountiful, UT 84010More trials in Bountiful
- Alliance for Multispecialty Research Layton Research Center · Layton, UT 84041More trials in Layton
- Chrysalis Clinical Research, LLC · St. George, UT 84790More trials in St. George
VA
- Washington Center for Weight Management and Research, Inc · Arlington, VA 22206More trials in Arlington
- Health Research of Hampton Roads · Newport News, VA 23606More trials in Newport News
- Selma Medical Associates · Winchester, VA 22601More trials in Winchester
WI
- Allegiance Research Specialists · Wauwatosa, WI 53226More trials in Wauwatosa