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Retatrutide

Phase 3

Type 2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Apr 13, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,320
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06297603Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)PHASE3 ACTIVE NOT_RECRUITING 320Mar 15, 2024Nov 1, 2026Dec 24, 202576 United States, Argentina +5
NCT05929079A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or OverweightPHASE3 ACTIVE NOT_RECRUITING 1,000Jul 11, 2023May 1, 2026Apr 13, 202698 United States, Argentina +6
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Study Endpoints
Primary Endpoints
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Baseline, Week 52
Percent Change from Baseline in Body Weight
Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Baseline, Week 80
Secondary Endpoints
Percentage of Participants Achieving HbA1c <7.0%
Week 52
Percentage of Participants Achieving HbA1c ≤6.5%
Week 52
Change from Baseline in Fasting Serum Glucose
Baseline, Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Retatrutide Dose 1EXPERIMENTALParticipants will receive retatrutide administered subcutaneously (SC).
Retatrutide Dose 2EXPERIMENTALParticipants will receive retatrutide administered SC.
Retatrutide Dose 3EXPERIMENTALParticipants will receive retatrutide administered SC.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo administered SC.
Interventions
NameTypeDescription
RetatrutideDRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites76

Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol) * Have moderate or severe renal impairment * Have been on the following stable diabetes treatment during 90 days prior to screening * basal insulin (≥20 International U...

Countries:United StatesArgentinaBrazilIsraelMexicoPuerto RicoUnited KingdomAustraliaIndiaRomaniaSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06297603primaryCompletionDate: changed
LOWMay 26, 2026NCT05929079primaryCompletionDate: changed
LOWMay 24, 2026NCT06297603studyFirstPostDate: changed
LOWMay 24, 2026NCT05929079studyFirstPostDate: changed