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

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: CIVI 007

• Registration Number: NCT04164888
• Lead Sponsor: Civi Biopharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-15
• Primary Completion: 2020-06-18
• Study Completion: 2020-11-17
• Disposition First Submitted: 2021-01-26
• Results First Submitted: 2025-01-20
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Results First Posted: 2025-02-13
• Disposition First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	CIVI 007	Placebo SC injection matching PCSK9 inhibitor given twice
CIVI 007, Dose B	CIVI 007	SC injection of PCSK9 inhibitor- dose titration
CIVI 007, Dose C	CIVI 007	SC injection of PCSK9 inhibitor- high dose given twice
CIVI 007, Dose A	CIVI 007	Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice

Primary Outcome Measures

Name	Time	Method
Assessment of the Pharmacodynamic Effect of CIVI 007	Baseline, D29, D57, D85	Percent change from baseline in PCSK9

Secondary Outcome Measures

Name	Time	Method
Assessment of the Lipid Efficacy of CIVI 007	Baseline, Day 29, Day 57, Day 85	Percent change from baseline in LDL-C
Assessment of CIVI 007 Adverse Events (AEs)	Baseline through 2 month follow-up	Incidence of any drug-related AEs

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States