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LIB003

Phase 2

LDL Cholesterol | Monoclonal antibody | Cardiovascular |Medpace Holdings, Inc. Common Stock|Last Updated: Feb 18, 2019

Development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Jun 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

LIB003 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT03549260Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C ReductionLDL Cholesterol
COMPLETED81 Analytics
PHASE2COMPLETED
Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
LDL Cholesterol
NCT0354926081
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Study Endpoints

Primary Endpoints

Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12
baseline to 12 weeks

Change in serum LDL-C from baseline after 12 weeks

The incidence and severity of treatment emergent adverse events (TEAEs)
43 days

safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events

Secondary Endpoints

The incidence and severity of treatment emergent adverse events (TEAEs)
baseline to 12 weeks
Percent reduction in apolipoprotein B (Apo B) at week 12
baseline to 12 weeks
Percent reduction in lipoprotein (a) [Lp(a)] at week 12
baseline to 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LIB003 150 mg or matching placeboEXPERIMENTALSC LIB003 150 mg or placebo every 4 weeks
LIB003 300 mg or matching placeboEXPERIMENTALSC LIB003 300 mg or placebo every 4 weeks
LIB003 350 mg or matching placeboEXPERIMENTALSC LIB003 350 mg or placebo every 4 weeks
cohort 1PLACEBO_COMPARATORLIB003 dose 1 SC
cohort 2PLACEBO_COMPARATORLIB003 dose 2 SC
cohort 3PLACEBO_COMPARATORLIB003 dose 4 SC
cohort 4PLACEBO_COMPARATORLIB003 dose 4 SC
cohort 5PLACEBO_COMPARATORLIB003 dose 5 SC
cohort 6PLACEBO_COMPARATORLIB003 dose 4 IV
cohort 7PLACEBO_COMPARATORLIB003 dose 5 IV
cohort 8PLACEBO_COMPARATORLIB003 dose 3 SC - statin treated
cohort 9PLACEBO_COMPARATORLIB003 dose 4 SC - statin treated

Interventions

NameTypeDescription
LIB003BIOLOGICALLIB003 or placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Male or female, 18 years of age or older 2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years...

Countries:United States
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Competitive Landscape -Dyslipidemia / Hypercholesterolemia 38 trials (matched to "LDL Cholesterol")

Top 12 of 13 competitors

CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS11PHASE3Inclisiran, Pelacarsen, DII235
Arrowhead Pharmaceuticals, Inc.ARWR6PHASE3Plozasiran, zodasiran
Merck & Co., Inc.MRK3PHASE3Enlicitide
AstraZeneca PLCAZN1PHASE3AZD0780
Ionis Pharmaceuticals, Inc.IONS1PHASE3Olezarsen
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Alirocumab
Eli Lilly and CompanyLLY1PHASE2Solbinsiran
MediciNova, Inc.MNOV1PHASE2MN-001
NewAmsterdam Pharma Company N.V.NAMS1PHASE1Obicetrapib
Verve Therapeutics, Inc.VERV3PHASE1VERVE-102, VERVE-201
CRISPR Therapeutics AGCRSP1PHASE1CTX310
Esperion Therapeutics, Inc.ESPR1 - Bempedoic acid+ Ezetimibe
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