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NCT07684235RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
3200 (estimated)
First submitted
29 Jun 2026
Start date
23 Jul 2026
Primary completion date
26 Dec 2027
Lead sponsor
Amgen
Diseases
Obesity
NCT number
NCT07684235

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 3200
  • From 23 Jul 2026 to the primary completion date, 26 Dec 2027
  • 91 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • 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).

Who the study is looking for

  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (91)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fusion Clinical Research
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AdelaideAustraliaRecruiting
Emeritus Research Sydney
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BotanyAustraliaRecruiting
Emeritus Research Camberwell
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CamberwellAustraliaRecruiting
Novatrials
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CharlestownAustraliaRecruiting
Logan Hospital
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MeadowbrookAustraliaRecruiting
Canopy Clinical Sutherland
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MirandaAustraliaRecruiting
Canopy Clinical Wollongong
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MirandaAustraliaRecruiting
Canopy Clinical Altona North
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North AltonaAustraliaRecruiting
Ecogene-21
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ChicoutimiCanadaRecruiting
Wharton Medical Clinic
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HamiltonCanadaRecruiting
Curans Heart Center
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Thunder BayCanadaRecruiting
Doujin Memorial Foundation, Meiwa Hospital
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Chiyoda-kuJapanRecruiting
Tokyo Asbo Clinic
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Chuo-kuJapanRecruiting
Medical Corp Seikoukai New Medical Research System Clinic
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Hachioji-shiJapanRecruiting
Medical Corporation AOT Shinagawa Strings Clinic
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Minato-kuJapanRecruiting
Clinical Research Hospital Tokyo
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Shinjuku-kuJapanRecruiting
Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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Suginami-kuJapanRecruiting
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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YokohamaJapanRecruiting
Puerto Rico Medical Research Inc.
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PoncePuerto RicoRecruiting
Ponce Medical School Foundation Inc.
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PoncePuerto RicoRecruiting
Latin Clinical Trial Center
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San JuanPuerto RicoRecruiting
Pinnacle Research Group, LLC
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AnnistonUnited StatesRecruiting
Washington Center for Weight Management and Research, Inc
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ArlingtonUnited StatesRecruiting
Elligo Clinical Research Center
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AustinUnited StatesRecruiting
Velocity Clinical Research - Baton Rouge
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Baton RougeUnited StatesRecruiting
Johnson County Clinical Trials Juno Bellaire
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BellaireUnited StatesRecruiting
Velocity Clinical Research - Binghamton
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BinghamtonUnited StatesRecruiting
Pantheon Clinical Research
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BountifulUnited StatesRecruiting
Flourish Research - Great Lakes Clinical Trials
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ChicagoUnited StatesRecruiting
Clinical Trial Investigator Clinical Research Center
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CincinnatiUnited StatesRecruiting
Velocity Clinical Research - Cincinnati
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CincinnatiUnited StatesRecruiting
Cedar Health Research, LLC
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DallasUnited StatesRecruiting
Alliance For Multispecialty Research - Daphne
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DaphneUnited StatesRecruiting
Epic Medical Research - Red Oak
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DeSotoUnited StatesRecruiting
Velocity Clinical Research, Providence
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East GreenwichUnited StatesRecruiting
Great Lakes Research Institute El Paso Research
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El PasoUnited StatesRecruiting
Prime Health and Wellness Sky Clinical Research Network Group
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FayetteUnited StatesRecruiting
Ark Clinical Research- Tustin
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Fountain ValleyUnited StatesRecruiting
Center for Advanced Research and Education
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GainesvilleUnited StatesRecruiting
Tribe Clinical Research LLC DBA Mountain View Clinical Research
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GreenvilleUnited StatesRecruiting
Accellacare of Hickory
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HickoryUnited StatesRecruiting
East-West Medical Research
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HonoluluUnited StatesRecruiting
Biopharma Informatic, LLC
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HoustonUnited StatesRecruiting
Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesRecruiting
Clinical Neuroscience Solutions - Jacksonville
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JacksonvilleUnited StatesRecruiting
Alliance for Multispecialty Research - Kansas City
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Kansas CityUnited StatesRecruiting
New Phase Research And Development
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KnoxvilleUnited StatesRecruiting
Accellacare US Inc., d/b/a Accellacare of Knoxville
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KnoxvilleUnited StatesRecruiting
Vector Clinical Trials
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Las VegasUnited StatesRecruiting
Palm Research Center Inc
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Las VegasUnited StatesRecruiting
South Florida Wellness and Clinical Research Institute
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LauderhillUnited StatesRecruiting
Alliance for Multispecialty Research Layton Research Center
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LaytonUnited StatesRecruiting
JCCT- Juno Northwest Houston
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LenexaUnited StatesRecruiting
Long Beach Clinical Trials Services, Inc
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Long BeachUnited StatesRecruiting
Ark Clinical Research - Long Beach
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Long BeachUnited StatesRecruiting
Louisville Metabolic and Atherosclerosis Research Center
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LouisvilleUnited StatesRecruiting
Tandem Clinical Research - Marrero
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MarreroUnited StatesRecruiting
Solaris Clinical Research
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MeridianUnited StatesRecruiting
Southern Endocrinology Associates PA
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MesquiteUnited StatesRecruiting
Research Institute of South Florida
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MiamiUnited StatesRecruiting
Optimus U Corporation
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MiamiUnited StatesRecruiting
Indago Research and Health Center
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Miami LakesUnited StatesRecruiting
Alliance for Multispecialty Research Mobile
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MobileUnited StatesRecruiting
Catalina Research Institute
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MontclairUnited StatesRecruiting
Capital Area Research LLC
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NewportUnited StatesRecruiting
Health Research of Hampton Roads
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Newport NewsUnited StatesRecruiting
Alliance for Multispecialty Research Newton
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NewtonUnited StatesRecruiting
Alliance for Multispecialty Research - Norman
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NormanUnited StatesRecruiting
Renstar Medical Research
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OcalaUnited StatesRecruiting
Combined Research Orlando Phase I-IV
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OrlandoUnited StatesRecruiting
Florida Institute for Clinical Research
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OrlandoUnited StatesRecruiting
Clinical Neuroscience Solutions - Orlando
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OrlandoUnited StatesRecruiting
Great Lakes Research Institute - McAllen Research
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PharrUnited StatesRecruiting
Artemis Institute for Clinical Research
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RiversideUnited StatesRecruiting
Rochester Clinical Research
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RochesterUnited StatesRecruiting
Clinical Trials of Texas
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San AntonioUnited StatesRecruiting
Apex Clinical Research
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San DiegoUnited StatesRecruiting
Artemis Institute for Clinical Research
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San DiegoUnited StatesRecruiting
Southern California Clinical Research
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Santa AnaUnited StatesRecruiting
Carolina Research Center, Inc
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ShelbyUnited StatesRecruiting
Evanston Premier Healthcare Research, LLC
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SkokieUnited StatesRecruiting
Endeavor Health
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SkokieUnited StatesRecruiting
Headlands Research - Detroit
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SouthfieldUnited StatesRecruiting
Chrysalis Clinical Research, LLC
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St. GeorgeUnited StatesRecruiting
Sugar Lakes Family Practice
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Sugar LandUnited StatesRecruiting
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Union CityUnited StatesRecruiting
Diablo Clinical Research
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Walnut CreekUnited StatesRecruiting
Chase Medical Research, LLC
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WaterburyUnited StatesRecruiting
Allegiance Research Specialists
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WauwatosaUnited StatesRecruiting
Encore Medical Research of Weston, LLC
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WestonUnited StatesRecruiting
Selma Medical Associates
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WinchesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.