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Trial record 25 of 74 for:    Recruiting, Not yet recruiting, Available Studies | "Hypercholesterolemia"

Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

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ClinicalTrials.gov Identifier: NCT04034485
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
LIB Therapeutics LLC

Brief Summary:
To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks [Q4W]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy

Condition or disease Intervention/treatment Phase
Homozygous Familial Hypercholesterolemia Drug: LIB003 Drug: evolocumab Phase 3

Detailed Description:
Patients with verified HoFH on stable and continuing doses of oral lipid lowering therapy will be randomized to either evolocumab 420 mg Q4W or LIB003 300 mg Q4W for 24 weeks (Period A). At Week 24, subjects will be crossed over to LIB003 if they were on evolocumab and vice versa for the next 24 weeks (Period B).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: open label, randomized, cross-over
Masking: None (Open Label)
Masking Description: treatment is open label but lipid results are masked to participant and investigator
Primary Purpose: Treatment
Official Title: Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy
Estimated Study Start Date : August 12, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arm Intervention/treatment
Experimental: LIB003
300 mg SC Q4W
Drug: LIB003
PCSK9 inhibitor

Active Comparator: evolocumab
420 mg SC Q4W
Drug: evolocumab
PCSK9 inhibitor




Primary Outcome Measures :
  1. Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24 [ Time Frame: baseline to 24 weeks on each treatment ]
    Change in serum LDL-C from baseline after 24 weeks


Secondary Outcome Measures :
  1. The incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: baseline to 24 weeks on each treatment ]
    safety and tolerability will be based on the incidence and severity of treatment emergent adverse events


Other Outcome Measures:
  1. Percent reduction in lipoprotein (a) [Lp(a)] at week 24 [ Time Frame: baseline to 24 weeks on each treatment ]
    Change in serum Lp(a) from baseline after 24 weeks

  2. Percent reduction in apolipoprotein B (Apo B) at week 24 [ Time Frame: baseline to 24 weeks on each treatment ]
    Change in serum Apo B from baseline after 24 weeks

  3. Presence of anti LIB003 antibodies (ADAs) [ Time Frame: baseline to 24 weeks ]
    Measurement of ADAs at baseline and various intervals



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HoFH diagnosed either clinically or genetically
  • Weight of >30 kg and body mass index (BMI) >18 and <40 kg/m2
  • stable diet and lipid-lowering oral therapies for at least 4 weeks

Exclusion Criteria:

  • mipomersen within 6 months of screening;
  • LDL or plasma apheresis <2 months prior to randomization
  • history of non-response to PCSK9 mAb or presence of receptor negative/null LDLR activity expected to result in non-response to PCSK9 inhibition
  • prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034485


Contacts
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Contact: Rebecca Bakker, RPh 734-730-1170 RBakker@libtherapeutics.com
Contact: Evan A Stein, MD PhD 8596533141 estein@libtherapeutics.com

Locations
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United States, Ohio
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
LIB Therapeutics LLC
Investigators
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Study Director: Evan A Stein, MD PhD LIB Therapeutics

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Responsible Party: LIB Therapeutics LLC
ClinicalTrials.gov Identifier: NCT04034485     History of Changes
Other Study ID Numbers: LIB003-003
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LIB Therapeutics LLC:
LDL cholesterol
PCSK9 inhibition
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Evolocumab
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs