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

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.

Timeline

Start

2019-11-11

Primary completion

2020-06-18

Completion

2020-11-17

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Experimental: CIVI 007, Dose A; p <0.0001; Least Square Mean -84.56 (95% CI -98.95 to -70.18); ANCOVA NCT04164888 ↗

Drugs

Indications