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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CIVI 007

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

CIVI 007, Dose A

CIVI 007, Dose B

CIVI 007, Dose C

Placebo

Arm Description

Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice

SC injection of PCSK9 inhibitor- dose titration

SC injection of PCSK9 inhibitor- high dose given twice

Placebo SC injection matching PCSK9 inhibitor given twice

Outcomes

Primary Outcome Measures

Assessment of CIVI 007 adverse events (AEs)

Incidence of any drug-related AEs

Assessment of CIVI 007 safety laboratory abnormalities

Incidence of clinically significant safety laboratory abnormalities

Secondary Outcome Measures

Assessment of the pharmacodynamic effect of CIVI 007

Percent change from baseline in PCSK9

Assessment of the pharmacodynamic (PD) effect of CIVI 007

Percent change from baseline in PCSK9

Assessment of the lipid efficacy of CIVI 007

Percent change from baseline in LDL-C

Assessment of the lipid efficacy of CIVI 007

Percent change from baseline in LDL-C

Full Information

NCT ID

NCT04164888

First Posted

November 12, 2019

Last Updated

January 26, 2021

Sponsor

Civi Biopharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04164888

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

November 11, 2019 (Actual)

Primary Completion Date

June 18, 2020 (Actual)

Study Completion Date

November 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Civi Biopharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CIVI 007, Dose A

Arm Type

Experimental

Arm Description

Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice

Arm Title

CIVI 007, Dose B

Arm Type

Experimental

Arm Description

SC injection of PCSK9 inhibitor- dose titration

Arm Title

CIVI 007, Dose C

Arm Type

Experimental

Arm Description

SC injection of PCSK9 inhibitor- high dose given twice

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo SC injection matching PCSK9 inhibitor given twice

Intervention Type

Drug

Intervention Name(s)

CIVI 007

Intervention Description

hypercholesterolemia agent

Primary Outcome Measure Information:

Title

Assessment of CIVI 007 adverse events (AEs)

Description

Incidence of any drug-related AEs

Time Frame

2 month followup

Title

Assessment of CIVI 007 safety laboratory abnormalities

Description

Incidence of clinically significant safety laboratory abnormalities

Time Frame

2 month followup

Secondary Outcome Measure Information:

Title

Assessment of the pharmacodynamic effect of CIVI 007

Description

Percent change from baseline in PCSK9

Time Frame

1 month followup

Title

Assessment of the pharmacodynamic (PD) effect of CIVI 007

Description

Percent change from baseline in PCSK9

Time Frame

2 month followup

Title

Assessment of the lipid efficacy of CIVI 007

Description

Percent change from baseline in LDL-C

Time Frame

1 month followup

Title

Assessment of the lipid efficacy of CIVI 007

Description

Percent change from baseline in LDL-C

Time Frame

2 month followup

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles L Shear, DrPH

Organizational Affiliation

CiVi Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Research Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Research Site

City

Munroe Falls

State/Province

Ohio

ZIP/Postal Code

44224

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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