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Maridebart cafraglutide

Phase 3

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight | Small molecule | Metabolic |Amgen Inc.|Last Updated: Dec 31, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06858878Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightPHASE3 ACTIVE NOT_RECRUITING 1,105 — — Mar 17, 2025Apr 16, 2027Dec 31, 2025187 United States, Argentina +11
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Study Endpoints
Primary Endpoints
Percent Change from Baseline in Body Weight at Week 72
Baseline and Week 72
Secondary Endpoints
Change from Baseline in Waist Circumference at Week 72
Baseline and Week 72
Participant achieving ≥ 5% reduction in body weight from baseline at week 72
Baseline and Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Baseline and Week 72
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Maridebart Cafraglutide High DoseEXPERIMENTALParticipants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Maridebart Cafraglutide Medium DoseEXPERIMENTALParticipants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Maridebart Cafraglutide Low DoseEXPERIMENTALParticipants will receive maridebart cafraglutide low dose SC for 72 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo SC for 72 weeks.
Interventions
NameTypeDescription
Maridebart cafraglutideDRUGMaridebart cafraglutide will be adminstered SC.
PlaceboDRUGPlacebo will be adminstered SC.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites187

Inclusion Criteria: * Age ≥ 18 years. * Body mass index ≥ 27 kg/m\^2. * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. * Diagnosis of T2DM. Exclusion Criteria: * Type 1 diabetes mellitus. * Self-reported change in body weight \> 5 kg within 90 days b...

Countries:United StatesArgentinaBulgariaCanadaCzechiaGermanyHungaryItalyJapanPolandPuerto RicoSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06858878primaryCompletionDate: changed
LOWMay 24, 2026NCT06858878studyFirstPostDate: changed