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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164888
• Other study ID #: CIVI 007-02-01
• Status: Completed
• Phase: Phase 2
• Start date: November 11, 2019
• Est. completion date: November 17, 2020

Study information

• Verified date: January 2021
• Source: Civi Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 17, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• CIVI 007
hypercholesterolemia agent

Locations

Country	Name	City	State
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Louisville	Kentucky
United States	Research Site	Munroe Falls	Ohio
United States	Research Site	Port Orange	Florida
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Civi Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of CIVI 007 adverse events (AEs)	Incidence of any drug-related AEs	2 month followup
Primary	Assessment of CIVI 007 safety laboratory abnormalities	Incidence of clinically significant safety laboratory abnormalities	2 month followup
Secondary	Assessment of the pharmacodynamic effect of CIVI 007	Percent change from baseline in PCSK9	1 month followup
Secondary	Assessment of the pharmacodynamic (PD) effect of CIVI 007	Percent change from baseline in PCSK9	2 month followup
Secondary	Assessment of the lipid efficacy of CIVI 007	Percent change from baseline in LDL-C	1 month followup
Secondary	Assessment of the lipid efficacy of CIVI 007	Percent change from baseline in LDL-C	2 month followup