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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2020-11-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CIVI 007, Dose A

Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice

Group Type EXPERIMENTAL

CIVI 007

Intervention Type DRUG

hypercholesterolemia agent

CIVI 007, Dose B

SC injection of PCSK9 inhibitor- dose titration

Group Type EXPERIMENTAL

CIVI 007

Intervention Type DRUG

hypercholesterolemia agent

CIVI 007, Dose C

SC injection of PCSK9 inhibitor- high dose given twice

Group Type EXPERIMENTAL

CIVI 007

Intervention Type DRUG

hypercholesterolemia agent

Placebo

Placebo SC injection matching PCSK9 inhibitor given twice

Group Type PLACEBO_COMPARATOR

CIVI 007

Intervention Type DRUG

hypercholesterolemia agent

Interventions

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CIVI 007

hypercholesterolemia agent

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No