Phase 2
Completed N=49
Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy
Source: ClinicalTrials.gov NCT04164888 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Feb 2025
Primary outcomePrimary: Assessment of the Pharmacodynamic Effect of CIVI 007 — -4.54; -71.38; -76.01; -82.27 percentage change from baseline — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the Pharmacodynamic Effect of CIVI 007 |
-4.54; -71.38; -76.01; -82.27; -7.42; -81.08 | <0.0001 sig |
| SECONDARY Assessment of the Lipid Efficacy of CIVI 007 |
-0.86; -52.37; -56.44; -51.70; -10.85; -51.21 | <0.0001 sig |
| SECONDARY Assessment of CIVI 007 Adverse Events (AEs) |
4; 2; 5; 1; 1; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04164888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.