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

• Status: Completed
• Trial end date: 2020-11-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Civi Biopharma, Inc.

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