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LY3502970

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Oct 17, 2023

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment383
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05048719A Study of LY3502970 in Participants With Type 2 Diabetes MellitusPHASE2 COMPLETED 383Sep 15, 2021Sep 30, 2022Oct 17, 202344 United States, Hungary +3
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Study Endpoints
Primary Endpoints
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
Baseline, Week 26

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Secondary Endpoints
Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide
Baseline, Week 26
Percentage of Participants With HbA1c ≤ 6.5%
Week 26
Percentage of Participants With HbA1c <7.0%
Week 26
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
3 milligrams (mg) LY3502970EXPERIMENTALParticipants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).
12 mg LY3502970EXPERIMENTALParticipants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
24 mg LY3502970EXPERIMENTALParticipants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
36 mg LY3502970 - 1EXPERIMENTALParticipants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
36 mg LY3502970 - 2EXPERIMENTALParticipants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
45 mg LY3502970 - 1EXPERIMENTALParticipants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
45 mg LY3502970 - 2EXPERIMENTALParticipants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
1.5 mg DulaglutideACTIVE_COMPARATORParticipants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
PlaceboPLACEBO_COMPARATORParticipants received matching placebo.
Interventions
NameTypeDescription
LY3502970DRUGAdministered orally
DulaglutideDRUGAdministered subcutaneously
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin * Have a stable body weight for the 3 months prior to randomization * Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²) * Males must agree to use highly effective metho...

Countries:United StatesHungaryPolandPuerto RicoSlovakia
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