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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: CIVI 007


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIVI 007, Dose A<br>Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice | Drug: CIVI 007<br>* hypercholesterolemia agent<br>|
| Experimental: CIVI 007, Dose B<br>SC injection of PCSK9 inhibitor- dose titration | Drug: CIVI 007<br>* hypercholesterolemia agent<br>|
| Experimental: CIVI 007, Dose C<br>SC injection of PCSK9 inhibitor- high dose given twice | Drug: CIVI 007<br>* hypercholesterolemia agent<br>|
| Placebo Comparator: Placebo<br>Placebo SC injection matching PCSK9 inhibitor given twice | Drug: CIVI 007<br>* hypercholesterolemia agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of CIVI 007 adverse events (AEs) | Incidence of any drug-related AEs | 2 month followup | 
| Assessment of CIVI 007 safety laboratory abnormalities | Incidence of clinically significant safety laboratory abnormalities | 2 month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the pharmacodynamic effect of CIVI 007 | Percent change from baseline in PCSK9 | 1 month followup | 
| Assessment of the pharmacodynamic (PD) effect of CIVI 007 | Percent change from baseline in PCSK9 | 2 month followup | 
| Assessment of the lipid efficacy of CIVI 007 | Percent change from baseline in LDL-C | 1 month followup | 
| Assessment of the lipid efficacy of CIVI 007 | Percent change from baseline in LDL-C | 2 month followup |