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

NCT04164888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-02-13

Study results available
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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

Interventions

DRUG

CIVI 007

hypercholesterolemia agent

Sponsors & Collaborators

  • Civi Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles L Shear, DrPH · CiVi Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2020-06-18
Completion
2020-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04164888 on ClinicalTrials.gov