HypercholesterolemiaPhase 2NCT04164888
Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy
A Phase 2 study testing CIVI 007 in people with Hypercholesterolemia, run by Civi Biopharma, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- CIVI 007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Nov 2019to 17 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Research Site
Cincinnati, Ohio, 45227
Research Site
Indianapolis, Indiana, 46260
Research Site
Jacksonville, Florida, 32216
Research Site
Louisville, Kentucky, 40213
Research Site
Munroe Falls, Ohio, 44224
Research Site
Port Orange, Florida, 32127
Research Site
San Antonio, Texas, 78229
About this study
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
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
- Hypercholesterolemia
- Being tested
- CIVI 007
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIVI 007Drug
hypercholesterolemia agent
| Study group | Role | What they receive |
|---|---|---|
| CIVI 007, Dose A | Experimental | Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice Receives: Drug: CIVI 007 |
| CIVI 007, Dose B | Experimental | SC injection of PCSK9 inhibitor- dose titration Receives: Drug: CIVI 007 |
| CIVI 007, Dose C | Experimental | SC injection of PCSK9 inhibitor- high dose given twice Receives: Drug: CIVI 007 |
| Placebo | Placebo comparator | Placebo SC injection matching PCSK9 inhibitor given twice Receives: Drug: CIVI 007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Pharmacodynamic Effect of CIVI 007
Percent change from baseline in PCSK9
Measured: Baseline, D29, D57, D85
Secondary outcomes (2)
Assessment of the Lipid Efficacy of CIVI 007
Percent change from baseline in LDL-C
Measured: Baseline, Day 29, Day 57, Day 85
Assessment of CIVI 007 Adverse Events (AEs)
Incidence of any drug-related AEs
Measured: Baseline through 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start11 Nov 2019
- Primary completion18 Jun 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Civi Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles L Shear, DrPH, Study director, CiVi Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164888
- Sponsor's protocol ID
- CIVI 007-02-01
- Status last verified
- Feb 2025
- First submitted
- 12 Nov 2019
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04164888
- Acronym / sponsor ID
- CIVI 007-02-01
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Civi Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CIVI 007, Dose A | Experimental | Drug: CIVI 007Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice |
| CIVI 007, Dose B | Experimental | Drug: CIVI 007SC injection of PCSK9 inhibitor- dose titration |
| CIVI 007, Dose C | Experimental | Drug: CIVI 007SC injection of PCSK9 inhibitor- high dose given twice |
| Placebo | Placebo comparator | Drug: CIVI 007Placebo SC injection matching PCSK9 inhibitor given twice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIVI 007hypercholesterolemia agent | Drug | CIVI 007, Dose A, CIVI 007, Dose B, CIVI 007, Dose C, Placebo |
Primary outcome
Assessment of the Pharmacodynamic Effect of CIVI 007
Time frame: Baseline, D29, D57, D85
Percent change from baseline in PCSK9
2 secondary outcomes
Assessment of the Lipid Efficacy of CIVI 007
Time frame: Baseline, Day 29, Day 57, Day 85
Assessment of CIVI 007 Adverse Events (AEs)
Time frame: Baseline through 2 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypercholesterolemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles L Shear, DrPH study director
CiVi Biopharma
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CIVI 007 in people with Hypercholesterolemia, run by Civi Biopharma, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Pharmacodynamic Effect of CIVI 007 (time frame: Baseline, D29, D57, D85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.