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LY2541546

Phase 2

Osteoporosis | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: Sep 17, 2019

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 Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01144377A Study of LY2541546 in Women With Low Bone Mineral DensityPHASE2 COMPLETED 154 — — Aug 1, 2010Feb 1, 2013Sep 17, 20198 United States, Denmark +3
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Study Endpoints
Primary Endpoints
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Baseline, 52 weeks

Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.

Secondary Endpoints
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Baseline, 12 weeks and 24 weeks and 64 weeks
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Baseline, 24 weeks and 52 weeks and 64 weeks
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)
Baseline, 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
180 mg LY2541546 Q4W + PlaceboEXPERIMENTALLY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
180 mg LY2541546 Q2WEXPERIMENTALLY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
270 mg LY2541546 Q2WEXPERIMENTALLY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
270 mg LY2541546 Q12W + PlaceboEXPERIMENTALLY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
Placebo Comparator Q2WPLACEBO_COMPARATORPlacebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Interventions
NameTypeDescription
LY2541546DRUGAdministered subcutaneously
PlaceboDRUGAdministered subcutaneously
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Eligibility Criteria
Age Range45 Years — 85 Years
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Ambulatory, postmenopausal women, inclusive. * Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute value (grams/square centimeter \[g/cm\^2\]) for the lumbar spine of between -3.5 and -2.0, inclusive. * Without language barrier, reliable, and w...

Countries:United StatesDenmarkEstoniaJapanLithuania
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Competitive Landscape -Osteoporosis 8 trials
CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Precision BioSciences, Inc.DTIL1NAUndisclosed
SI-BONE, Inc.SIBN1 — Undisclosed
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