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Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy

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ClinicalTrials.gov Identifier: NCT04164888
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Civi Biopharma, Inc.

Study Description
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Brief Summary:
Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: CIVI 007 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Randomized, Phase 2a, Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CIVI 007 in Patients on a Background of Stable Statin Therapy
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : June 18, 2020
Actual Study Completion Date : November 17, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CIVI 007, Dose A
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
 Drug: CIVI 007
hypercholesterolemia agent
Experimental: CIVI 007, Dose B
SC injection of PCSK9 inhibitor- dose titration
 Drug: CIVI 007
hypercholesterolemia agent
Experimental: CIVI 007, Dose C
SC injection of PCSK9 inhibitor- high dose given twice
 Drug: CIVI 007
hypercholesterolemia agent
Placebo Comparator: Placebo
Placebo SC injection matching PCSK9 inhibitor given twice
 Drug: CIVI 007
hypercholesterolemia agent


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of CIVI 007 adverse events (AEs) [ Time Frame: 2 month followup ]
    Incidence of any drug-related AEs

  2. Assessment of CIVI 007 safety laboratory abnormalities [ Time Frame: 2 month followup ]
    Incidence of clinically significant safety laboratory abnormalities


Secondary Outcome Measures :
  1. Assessment of the pharmacodynamic effect of CIVI 007 [ Time Frame: 1 month followup ]
    Percent change from baseline in PCSK9

  2. Assessment of the pharmacodynamic (PD) effect of CIVI 007 [ Time Frame: 2 month followup ]
    Percent change from baseline in PCSK9

  3. Assessment of the lipid efficacy of CIVI 007 [ Time Frame: 1 month followup ]
    Percent change from baseline in LDL-C

  4. Assessment of the lipid efficacy of CIVI 007 [ Time Frame: 2 month followup ]
    Percent change from baseline in LDL-C


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Body mass index (BMI) between 18.0 and 40.0
  2. Stable (>4 weeks prior to the Screening Visit) dose of statin therapy with or without ezetimibe
  3. Fasting low-density lipoprotein cholesterol (LDL-C): ≥100 mg/dL for those without cardiovascular disease, or ≥70 mg/dL for those with cardiovascular disease.
  4. Fasting triglycerides (TGs) <400 mg/dL

Key Exclusion Criteria:

  1. Women who are pregnant, nursing or breast feeding
  2. Currently prescribed a lipid lowering agent other than a statin or ezetimibe.
  3. Clinically significant disorder or laboratory abnormality that could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results
Contacts and Locations
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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): NCT04164888


Locations
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United States, Florida
Research Site
Jacksonville, Florida, United States, 32216
Research Site
Port Orange, Florida, United States, 32127
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40213
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45227
Research Site
Munroe Falls, Ohio, United States, 44224
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Civi Biopharma, Inc.
Investigators
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Study Director: Charles L Shear, DrPH CiVi Biopharma
More Information
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Responsible Party: Civi Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT04164888    
Other Study ID Numbers: CIVI 007-02-01
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases