CompletedNCT04164888Updated Feb 13, 2025Results posted

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

A Phase 2 interventional study of CIVI 007 in Hypercholesterolemia, sponsored by Civi Biopharma, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Civi Biopharma, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 49
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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 studied

Hypercholesterolemia

Browse trials for

Hypercholesterolemia 1,267

In context

Hypercholesterolemia

1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.

This study's enrollment of 49 is below the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Civi Biopharma, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 49 participants (actual)

Study arms

Experimental
CIVI 007, Dose A
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
Drug: CIVI 007
Experimental
CIVI 007, Dose B
SC injection of PCSK9 inhibitor- dose titration
Drug: CIVI 007
Experimental
CIVI 007, Dose C
SC injection of PCSK9 inhibitor- high dose given twice
Drug: CIVI 007
Placebo comparator
Placebo
Placebo SC injection matching PCSK9 inhibitor given twice
Drug: CIVI 007

Interventions

DrugCIVI 007
hypercholesterolemia agent

What researchers measure

Primary outcomes

Assessment of the Pharmacodynamic Effect of CIVI 007
Percent change from baseline in PCSK9
Time frame: Baseline, D29, D57, D85

Secondary outcomes

Assessment of the Lipid Efficacy of CIVI 007
Percent change from baseline in LDL-C
Time frame: Baseline, Day 29, Day 57, Day 85
Assessment of CIVI 007 Adverse Events (AEs)
Incidence of any drug-related AEs
Time frame: Baseline through 2 month follow-up

Results

Posted Feb 13, 2025

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Experimental: CIVI 007, Dose A	Experimental: CIVI 007, Dose B	Experimental: CIVI 007, Dose C
Started	12	12	13	12
Completed	12	12	13	12
Not completed	0	0	0	0

Outcome measures

PrimaryAssessment of the Pharmacodynamic Effect of CIVI 007

Percent change from baseline in PCSK9

Time frame:: Baseline, D29, D57, D85
Reported as:: Median · percentage change from baseline

Assessment of the Pharmacodynamic Effect of CIVI 007
percentage change from baseline	Placebo	Experimental: CIVI 007, Dose A	Experimental: CIVI 007, Dose B	Experimental: CIVI 007, Dose C
Day 29	-4.54 (-15.7 to 63.3)	-71.38 (-89.7 to -63.4)	-76.01 (-92.7 to -18.5)	-82.27 (-93.4 to -48.1)
Day 57	-7.42 (-31.6 to 25.8)	-81.08 (-91.0 to -69.9)	-85.48 (-93.0 to -67.6)	-83.42 (-92.2 to -71.2)
Day 85	-0.37 (-35.5 to 41.2)	-43.74 (-72.9 to -27.0)	-55.89 (-75.1 to -18.7)	-61.10 (-73.6 to -37.8)

Statistical analysis

Placebo vs Experimental: CIVI 007, Dose A · ANCOVA · p = <0.0001 · Least square mean: -84.56 · 95% CI -98.95 to -70.18ANCOVA with LOCF
Placebo vs Experimental: CIVI 007, Dose B · ANCOVA · p = <0.0001 · Least square mean: -80.43 · 95% CI -94.58 to -66.29ANCOVA with LOCF
Placebo vs Experimental: CIVI 007, Dose C · ANCOVA · p = <0.0001 · Least square mean: -84.87 · 95% CI -99.00 to -70.75ANCOVA with LOCF

SecondaryAssessment of the Lipid Efficacy of CIVI 007

Percent change from baseline in LDL-C

Time frame:: Baseline, Day 29, Day 57, Day 85
Reported as:: Median · percentage change from baseline

Assessment of the Lipid Efficacy of CIVI 007
percentage change from baseline	Placebo	Experimental: CIVI 007, Dose A	Experimental: CIVI 007, Dose B	Experimental: CIVI 007, Dose C
Day 29	-0.86 (-38.3 to 31.3)	-52.37 (-88.7 to -24.8)	-56.44 (-74.5 to -20.9)	-51.70 (-83.5 to -24.5)
Day 57	-10.85 (-57.2 to 42.2)	-51.21 (-71.8 to 27.3)	-61.18 (-82.0 to -14.3)	-59.18 (-82.4 to 1.0)
Day 85	-10.08 (-52.4 to 42.2)	-29.66 (-51.9 to 5.7)	-48.65 (-59.1 to 3.3)	-43.51 (-57.1 to 32.7)

Statistical analysis

Placebo vs Experimental: CIVI 007, Dose A · ANCOVA · p = <0.0001 · Least square mean: -48.03 · 95% CI -63.06 to -32.99ANCOVA with LOCF
Placebo vs Experimental: CIVI 007, Dose B · ANCOVA · p = <0.0001 · Least square mean: -49.59 · 95% CI -64.50 to 34.69ANCOVA with LOCF
Placebo vs Experimental: CIVI 007, Dose C · ANCOVA · p = <0.0001 · Least square mean: -51.99 · 95% CI -67.34 to -36.64ANCOVA with LOCF

SecondaryAssessment of CIVI 007 Adverse Events (AEs)

Incidence of any drug-related AEs

Time frame:: Baseline through 2 month follow-up
Reported as:: Count of participants · Participants

Assessment of CIVI 007 Adverse Events (AEs)
Participants	Placebo	Experimental: CIVI 007, Dose A	Experimental: CIVI 007, Dose B	Experimental: CIVI 007, Dose C
Mild	4	2	5	1
Moderate	1	1	3	2
Severe	0	1	0	0

Adverse events

Collected over Approximately 31 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CIVI 007, Dose A	0/12 (0%)	1/12 (8.3%)	8/12 (66.7%)
CIVI 007, Dose B	0/13 (0%)	0/13 (0%)	10/13 (76.9%)
CIVI 007, Dose C	0/12 (0%)	0/12 (0%)	6/12 (50%)
Placebo	0/12 (0%)	0/12 (0%)	9/12 (75%)

Most frequent serious events

Most frequent serious events
Event	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo
Alanine aminotransferase increasedInvestigations	1/12	0/13	0/12	0/12
Aspartate aminotransferase increasedInvestigations	1/12	0/13	0/12	0/12

Most frequent other events

Showing 10 of 49

Most frequent other events
Event	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo
Upper respiratory tract infectionInfections and infestations	4/12	1/13	1/12	0/12
Injection site erythemaGeneral disorders	1/12	3/13	0/12	1/12
ProteinuriaRenal and urinary disorders	0/12	3/13	0/12	1/12
Alanine aminotransferase increasedInvestigations	1/12	2/13	1/12	0/12
Injection site painGeneral disorders	0/12	2/13	0/12	0/12
AlbuminuriaRenal and urinary disorders	0/12	2/13	0/12	0/12
Aspartate aminotransferase increasedInvestigations	1/12	1/13	1/12	0/12
Blood creatine phosphokinase increasedInvestigations	1/12	1/13	0/12	0/12
Transaminases increasedInvestigations	1/12	0/13	0/12	1/12
Crystal urine presentInvestigations	0/12	0/13	0/12	1/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	10	10	8	8	36
>=65 years	2	3	4	4	13

Age, Continuous
Age, Continuous(years)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
Mean	57.7 ± 8.06	56.4 ± 9.48	56.3 ± 11.63	60.3 ± 8.93	57.6 ± 9.44

Sex: Female, Male
Sex: Female, Male(Participants)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
Female	5	4	3	6	18
Male	7	9	9	6	31

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
Hispanic or Latino	1	0	0	0	1
Not Hispanic or Latino	11	13	12	12	48
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	1	0	0	1
Native Hawaiian or Other Pacific Islander	0	1	0	0	1
Black or African American	3	3	2	4	12
White	9	8	10	8	35
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Childbearing potential, n
Childbearing potential, n(participants)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
Number	1	1	0	0	2

Height
Height(cm)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
Mean	171.0 ± 11.82	176.8 ± 10.58	174.9 ± 9.00	170.2 ± 10.40	173.3 ± 10.54

Weight
Weight(kg)	CIVI 007, Dose A	CIVI 007, Dose B	CIVI 007, Dose C	Placebo	Total
Mean	89.51 ± 12.011	98.55 ± 16.473	95.30 ± 18.659	82.56 ± 12.327	91.62 ± 15.924

7 further baseline measures are reported on the registry.

Study locations

7 sites

Research Site
Jacksonville, Florida 32216, United States
Research Site
Port Orange, Florida 32127, United States
Research Site
Indianapolis, Indiana 46260, United States
Research Site
Louisville, Kentucky 40213, United States
Research Site
Cincinnati, Ohio 45227, United States
Research Site
Munroe Falls, Ohio 44224, United States
Research Site
San Antonio, Texas 78229, United States

References and documents

Study documents

Study protocol · Nov 14, 2019
Statistical analysis plan · Feb 19, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04164888
Lead sponsor: Civi Biopharma, Inc.
Responsible party: Sponsor
First posted: Nov 15, 2019
Start date: Nov 11, 2019
Primary completion: Jun 18, 2020
Completion: Nov 17, 2020
Results posted: Feb 13, 2025
Last update: Feb 13, 2025

Study contacts

Charles L Shear, DrPH

study director · CiVi Biopharma

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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