Long-term study of maridebart cafraglutide in adults with obesity or overweight
Tests maridebart cafraglutide against placebo in adults with obesity or overweight.
Plain-language title generated from the registry record
Registry title: Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
Key facts
- Where
- Anniston, Arlington, Austin, Baton Rouge, Bellaire, Binghamton, Bountiful, Chicago, Cincinnati, Dallas, Daphne, DeSoto, East Greenwich, El Paso, Fayette, Fountain Valley, Gainesville, Greenville, Hickory, Honolulu, Houston, Jacksonville, Kansas City, Knoxville, Las Vegas, Lauderhill, Layton, Lenexa, Long Beach, Louisville, Marrero, Meridian, Mesquite, Miami, Miami Lakes, Mobile, Montclair, Newport, Newport News, Newton, Norman, Ocala, Orlando, Pharr, Riverside, Rochester, San Antonio, San Diego, Santa Ana, Shelby, Skokie, Southfield, St. George, Sugar Land, Union City, Walnut Creek, Waterbury, Wauwatosa, Weston, and Winchester, United StatesSee the 70 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07684235, who can take part
Where in United States
- Pinnacle Research Group, LLCAnniston, United StatesTaking people
- Washington Center for Weight Management and Research, IncArlington, United StatesTaking people
- Elligo Clinical Research CenterAustin, United StatesTaking people
- Velocity Clinical Research - Baton RougeBaton Rouge, United StatesTaking people
- Johnson County Clinical Trials Juno BellaireBellaire, United StatesTaking people
- Velocity Clinical Research - BinghamtonBinghamton, United StatesTaking people
- Pantheon Clinical ResearchBountiful, United StatesTaking people
- Flourish Research - Great Lakes Clinical TrialsChicago, United StatesTaking people
- Clinical Trial Investigator Clinical Research CenterCincinnati, United StatesTaking people
- Velocity Clinical Research - CincinnatiCincinnati, United StatesTaking people
- Cedar Health Research, LLCDallas, United StatesTaking people
- Alliance For Multispecialty Research - DaphneDaphne, United StatesTaking people
- Epic Medical Research - Red OakDeSoto, United StatesTaking people
- Velocity Clinical Research, ProvidenceEast Greenwich, United StatesTaking people
- Great Lakes Research Institute El Paso ResearchEl Paso, United StatesTaking people
- Prime Health and Wellness Sky Clinical Research Network GroupFayette, United StatesTaking people
- Ark Clinical Research- TustinFountain Valley, United StatesTaking people
- Center for Advanced Research and EducationGainesville, United StatesTaking people
- Tribe Clinical Research LLC DBA Mountain View Clinical ResearchGreenville, United StatesTaking people
- Accellacare of HickoryHickory, United StatesTaking people
- East-West Medical ResearchHonolulu, United StatesTaking people
- Biopharma Informatic, LLCHouston, United StatesTaking people
- Clinical Neuroscience Solutions - JacksonvilleJacksonville, United StatesTaking people
- Jacksonville Center for Clinical ResearchJacksonville, United StatesTaking people
- Alliance for Multispecialty Research - Kansas CityKansas City, United StatesTaking people
- Accellacare US Inc., d/b/a Accellacare of KnoxvilleKnoxville, United StatesTaking people
- New Phase Research And DevelopmentKnoxville, United StatesTaking people
- Palm Research Center IncLas Vegas, United StatesTaking people
- Vector Clinical TrialsLas Vegas, United StatesTaking people
- South Florida Wellness and Clinical Research InstituteLauderhill, United StatesTaking people
- Alliance for Multispecialty Research Layton Research CenterLayton, United StatesTaking people
- JCCT- Juno Northwest HoustonLenexa, United StatesTaking people
- Ark Clinical Research - Long BeachLong Beach, United StatesTaking people
- Long Beach Clinical Trials Services, IncLong Beach, United StatesTaking people
- Louisville Metabolic and Atherosclerosis Research CenterLouisville, United StatesTaking people
- Tandem Clinical Research - MarreroMarrero, United StatesTaking people
- Solaris Clinical ResearchMeridian, United StatesTaking people
- Southern Endocrinology Associates PAMesquite, United StatesTaking people
- Optimus U CorporationMiami, United StatesTaking people
- Research Institute of South FloridaMiami, United StatesTaking people
- Indago Research and Health CenterMiami Lakes, United StatesTaking people
- Alliance for Multispecialty Research MobileMobile, United StatesTaking people
- Catalina Research InstituteMontclair, United StatesTaking people
- Capital Area Research LLCNewport, United StatesTaking people
- Health Research of Hampton RoadsNewport News, United StatesTaking people
- Alliance for Multispecialty Research NewtonNewton, United StatesTaking people
- Alliance for Multispecialty Research - NormanNorman, United StatesTaking people
- Renstar Medical ResearchOcala, United StatesTaking people
- Clinical Neuroscience Solutions - OrlandoOrlando, United StatesTaking people
- Combined Research Orlando Phase I-IVOrlando, United StatesTaking people
- Florida Institute for Clinical ResearchOrlando, United StatesTaking people
- Great Lakes Research Institute - McAllen ResearchPharr, United StatesTaking people
- Artemis Institute for Clinical ResearchRiverside, United StatesTaking people
- Rochester Clinical ResearchRochester, United StatesTaking people
- Clinical Trials of TexasSan Antonio, United StatesTaking people
- Apex Clinical ResearchSan Diego, United StatesTaking people
- Artemis Institute for Clinical ResearchSan Diego, United StatesTaking people
- Southern California Clinical ResearchSanta Ana, United StatesTaking people
- Carolina Research Center, IncShelby, United StatesTaking people
- Endeavor HealthSkokie, United StatesTaking people
- Evanston Premier Healthcare Research, LLCSkokie, United StatesTaking people
- Headlands Research - DetroitSouthfield, United StatesTaking people
- Chrysalis Clinical Research, LLCSt. George, United StatesTaking people
- Sugar Lakes Family PracticeSugar Land, United StatesTaking people
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network GroupUnion City, United StatesTaking people
- Diablo Clinical ResearchWalnut Creek, United StatesTaking people
- Chase Medical Research, LLCWaterbury, United StatesTaking people
- Allegiance Research SpecialistsWauwatosa, United StatesTaking people
- Encore Medical Research of Weston, LLCWeston, United StatesTaking people
- Selma Medical AssociatesWinchester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT07684235
- Record updated
- 5 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity; 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; 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; History of ischemic optic neuropathy; Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative[s]) history of medullary thyroid cancer; 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; 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; 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; 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; Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).