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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: CIVI 007

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Port Orange, Florida, United States, 32127
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Research Site
    • Munroe Falls, Ohio, United States, 44224
      • Research Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CIVI 007, Dose A; Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice	Drug: CIVI 007; hypercholesterolemia agent
EXPERIMENTAL: CIVI 007, Dose B; SC injection of PCSK9 inhibitor- dose titration	Drug: CIVI 007; hypercholesterolemia agent
EXPERIMENTAL: CIVI 007, Dose C; SC injection of PCSK9 inhibitor- high dose given twice	Drug: CIVI 007; hypercholesterolemia agent
PLACEBO_COMPARATOR: Placebo; Placebo SC injection matching PCSK9 inhibitor given twice	Drug: CIVI 007; hypercholesterolemia agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of CIVI 007 adverse events (AEs)	Incidence of any drug-related AEs	2 month followup
Assessment of CIVI 007 safety laboratory abnormalities	Incidence of clinically significant safety laboratory abnormalities	2 month followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the pharmacodynamic effect of CIVI 007	Percent change from baseline in PCSK9	1 month followup
Assessment of the pharmacodynamic (PD) effect of CIVI 007	Percent change from baseline in PCSK9	2 month followup
Assessment of the lipid efficacy of CIVI 007	Percent change from baseline in LDL-C	1 month followup
Assessment of the lipid efficacy of CIVI 007	Percent change from baseline in LDL-C	2 month followup

Collaborators and Investigators

• Sponsor: Civi Biopharma, Inc.
• Investigators: Study Director: Charles L Shear, DrPH, CiVi Biopharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2019
• Primary Completion (ACTUAL): June 18, 2020
• Study Completion (ACTUAL): November 17, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (ACTUAL): November 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: CIVI 007-02-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No