Trials / Completed
CompletedNCT04164888
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Civi Biopharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | CIVI 007 | hypercholesterolemia agent |
Timeline
- Start date
- 2019-11-11
- Primary completion
- 2020-06-18
- Completion
- 2020-11-17
- First posted
- 2019-11-15
- Last updated
- 2025-02-13
- Results posted
- 2025-02-13
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04164888. Inclusion in this directory is not an endorsement.