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LY2484595

Phase 2

Dyslipidemia | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 22, 2018

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 Enrollment398
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01105975A Study of LY2484595 in Patients With High LDL-C or Low HDL-CPHASE2 COMPLETED 398 — — Apr 1, 2010Jun 1, 2011Mar 22, 201859 United States, Denmark +4
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Study Endpoints
Primary Endpoints
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Baseline, Week 12

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Baseline, Week 12

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Secondary Endpoints
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Baseline, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
30 milligram (mg) LY2484595 monotherapyEXPERIMENTAL -
100 mg LY2484595 monotherapyEXPERIMENTAL -
500 mg LY2484595 monotherapyEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
20 mg Atorvastatin monotherapyACTIVE_COMPARATOR -
100 mg LY2484595 + 20 mg AtorvastatinEXPERIMENTAL -
40 mg Simvastatin monotherapyACTIVE_COMPARATOR -
100 mg LY2484595 + 40 mg SimvastatinEXPERIMENTAL -
10 mg Rosuvastatin monotherapyACTIVE_COMPARATOR -
100 mg LY2484595 + 10 mg RosuvastatinEXPERIMENTAL -
Interventions
NameTypeDescription
LY2484595DRUGAdministered daily by mouth for 12 weeks
AtorvastatinDRUGAdministered daily by mouth for 12 weeks
SimvastatinDRUGAdministered daily by mouth for 12 weeks
RosuvastatinDRUGAdministered daily by mouth for 12 weeks
Placebo for LY2484595DRUGAdministered daily by mouth for 12 weeks
Placebo for StatinsDRUGAdministered daily by mouth for 12 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: • Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies Exclusion Criteria: * History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well * Hypertensi...

Countries:United StatesDenmarkGermanyNetherlandsPolandUnited Kingdom
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Competitive Landscape -Dyslipidemia 20 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY2PHASE3Lepodisiran, Muvalaplin
Merck & Co., Inc.MRK1PHASE3Enlicitide, Rosuvastatin
Novartis AG Sponsored ADRNVS2PHASE3TQJ230
NewAmsterdam Pharma Company N.V.NAMS3PHASE3obicetrapib + ezetimibe daily, obicetrapib + obicetrapib/evolocumab Q 2 weeks
AstraZeneca PLCAZN3PHASE2AZD0780, Rosuvastatin, Rosuvastatin Dose 1, AZD4954
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-DIMERPA
CRISPR Therapeutics AGCRSP1PHASE1CTX310
HeartFlow, Inc.HTFL1NARosuvastatin
Harvard Bioscience, Inc.HBIO1 — Undisclosed
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