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

CiVi Biopharma

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: CIVI 007

Study type: Interventional

Funder types: Industry

Identifiers

NCT04164888

CIVI 007-02-01

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 4 patient groups, including a placebo group

CIVI 007, Dose A

Experimental group

Description:

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

Treatment:

Drug: CIVI 007

CIVI 007, Dose B

Experimental group

Description:

SC injection of PCSK9 inhibitor- dose titration

Treatment:

Drug: CIVI 007

CIVI 007, Dose C

Experimental group

Description:

SC injection of PCSK9 inhibitor- high dose given twice

Treatment:

Drug: CIVI 007

Placebo

Placebo Comparator group

Description:

Placebo SC injection matching PCSK9 inhibitor given twice

Treatment:

Drug: CIVI 007