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Orforglipron

Phase 3

Osteoarthritis | Small molecule | Musculoskeletal |Eli Lilly and Company|Last Updated: Jun 4, 2026

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment800
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07153471A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the KneePHASE3 RECRUITING 800Sep 15, 2025May 1, 2028Jun 4, 202695 United States, Canada +6
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Study Endpoints
Primary Endpoints
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Baseline, Week 72
Secondary Endpoints
Change from Baseline in the WOMAC Physical Function Subscale Score
Baseline, Week 72
Percent Change from Baseline in Body Weight
Baseline, Week 72
Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Baseline, Week 72
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Orforglipron (GZT1)EXPERIMENTALParticipants will receive orforglipron orally
Placebo (GZT1)PLACEBO_COMPARATORParticipants will receive placebo orally
Orforglipron (GZT2)EXPERIMENTALParticipants will receive orforglipron orally
Placebo (GZT2)PLACEBO_COMPARATORParticipants will receive placebo orally
Interventions
NameTypeDescription
OrforglipronDRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites95

Inclusion Criteria: * Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening * Have tried at least once to lose weight through diet but were unsuccessful * Have osteoarthritis of the knee and at least one of the following conditions: * Be over 50 years old ...

Countries:United StatesCanadaChinaGermanyIndiaJapanMexicoSpain
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07153471lastUpdatePostDate: changed
LOWJun 4, 2026NCT07153471lastUpdatePostDate: changed
LOWJun 4, 2026NCT07153471lastUpdatePostDate: changed
LOWJun 4, 2026NCT07153471lastUpdatePostDate: changed
LOWMay 26, 2026NCT07153471primaryCompletionDate: changed
LOWMay 24, 2026NCT07153471studyFirstPostDate: changed