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OpenTrials
Completed

NCT Number: NCT04164888

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

CIVI 007

Drug

hypercholesterolemia agent

Primary outcomes

  1. Assessment of the Pharmacodynamic Effect of CIVI 007

    Time frame: Baseline, D29, D57, D85

    Percent change from baseline in PCSK9

Secondary outcomes

  1. Assessment of the Lipid Efficacy of CIVI 007

    Time frame: Baseline, Day 29, Day 57, Day 85

    Percent change from baseline in LDL-C

  2. Assessment of CIVI 007 Adverse Events (AEs)

    Time frame: Baseline through 2 month follow-up

    Incidence of any drug-related AEs

Sponsors and collaborators

Lead sponsor

Civi Biopharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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