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

NCT04164888 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CIVI 007-02-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Assessment of the Pharmacodynamic Effect of CIVI 007

  Percent change from baseline in PCSK9

  Baseline, D29, D57, D85

Secondary Outcomes (2)

• Assessment of the Lipid Efficacy of CIVI 007

  Baseline, Day 29, Day 57, Day 85

• Assessment of CIVI 007 Adverse Events (AEs)

  Baseline through 2 month follow-up

Study Arms (4)

CIVI 007, Dose A

EXPERIMENTAL

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

Drug: CIVI 007

CIVI 007, Dose B

EXPERIMENTAL

SC injection of PCSK9 inhibitor- dose titration

Drug: CIVI 007

CIVI 007, Dose C

EXPERIMENTAL

SC injection of PCSK9 inhibitor- high dose given twice

Drug: CIVI 007

Placebo

PLACEBO COMPARATOR

Placebo SC injection matching PCSK9 inhibitor given twice

Drug: CIVI 007

Interventions

CIVI 007 DRUG

hypercholesterolemia agent

CIVI 007, Dose A; CIVI 007, Dose B; CIVI 007, Dose C; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) between 18.0 and 40.0
• Stable (\>4 weeks prior to the Screening Visit) dose of statin therapy with or without ezetimibe
• Fasting low-density lipoprotein cholesterol (LDL-C): ≥100 mg/dL for those without cardiovascular disease, or ≥70 mg/dL for those with cardiovascular disease.
• Fasting triglycerides (TGs) \<400 mg/dL

You may not qualify if:

• Women who are pregnant, nursing or breast feeding
• Currently prescribed a lipid lowering agent other than a statin or ezetimibe.
• 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

Sponsors & Collaborators

• Civi Biopharma, Inc.: lead

Study Sites (7)

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Port Orange, Florida, 32127, United States

Location

Research Site

Indianapolis, Indiana, 46260, United States

Location

Research Site

Louisville, Kentucky, 40213, United States

Location

Research Site

Cincinnati, Ohio, 45227, United States

Location

Research Site

Munroe Falls, Ohio, 44224, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Chief, Clinical Development
• Organization: CiVi Biopharma, Inc.

chuck.shear@civibiopharma.com

484-674-5456

Study Officials

• Charles L Shear, DrPH

  CiVi Biopharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: November 11, 2019
• Primary Completion: June 18, 2020
• Study Completion: November 17, 2020
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Locations

US (7)