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

February 11, 2025 updated by: Civi Biopharma, Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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 the Pharmacodynamic Effect of CIVI 007
Time Frame: Baseline, D29, D57, D85
Percent change from baseline in PCSK9
Baseline, D29, D57, D85

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Civi Biopharma, Inc.

Investigators

  • Study Director: Charles L Shear, DrPH, CiVi Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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