HyperlipidemiaPhase 2NCT04438096
Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia
A Phase 2 study testing 100 mg, 200 mg and 300 mg in people with Hyperlipidemia, run by CVI Pharmaceuticals at 1 site in China.
Trial summary
The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- 100 mg, 200 mg and 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2020to 15 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 1. Aged 18-70 years, inclusive
- 2. Men and nonpregnant, nonlactating women
- 3. Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L~4.88mmol/L at screening, inclusive
Who cannot join
- 1. Fasting TG ≥3.99 mmol/L before randomization
- 2. History of significant cardiovascular , renal, pulmonary and liver diseases
- 3. History of diabetes
- 4. ALT or AST>1.5XULN at screening
Trial locations and contacts
1 site in 1 country.
Jingwen Liu, PhD contact
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of zhejiang University school of medicine
Hangzhou, 310009
JianAn Wang, MD, 0571-87315001, wang_jian_an@tom.vip.com
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of CVI-LM001 in Patients With Hypercholesterolemia
The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively.
Read the detailed description
This study is a phase II study in subjects with elevated LDL cholesterol. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. After run-in, eligibility is confirmed with required laboratory tests at Day -1 prior to randomization. The eligible subjects are randomly assigned to CVI-LM001 100 mg, 200 mg, 300mg QD group or placebo QD group with ratio 1:1:1:1 to receive a 12-week double-blind treatment. After 12-week treatment, all investigational compound and placebo should be discontinued, followed by 4 week for safety evaluation.
- Conditions
- Hyperlipidemia
- Being tested
- 100 mg, 200 mg, 300 mg, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mgDrug
One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks
200 mgDrug
Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks
300 mgDrug
Three 100 mg pills (QD) will be orally administered for 12 weeks
PlaceboDrug
Three placebo pills (QD) will be orally administered for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 100 mg | Experimental | Not described Receives: Drug: 100 mg |
| 200 mg | Experimental | Not described Receives: Drug: 200 mg |
| 300 mg | Experimental | Not described Receives: Drug: 300 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events
Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (8)
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
The percent change of Non-HDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
The percent change of TC from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
The percent change of ApoB from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Percent Change From Baseline to Week 12 in Triglyceride (TG)
The percent change of TG from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
The percent change of hsCRP from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a))
The percent change of Lp(a) from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)
The percent change of PCSK9 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)
The percent change of Apo A1 from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start15 Jul 2020 (estimated)
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CVI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Que Liu, MDPhD, Study chair, CVI Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438096
- Sponsor's protocol ID
- CVI-LM001-Ⅱ-01
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: lipid panel including LDL as well as safety data
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of CVI-LM001 in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04438096
- Acronym / sponsor ID
- CVI-LM001-Ⅱ-01
- Conditions
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CVI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively.
Detailed description
This study is a phase II study in subjects with elevated LDL cholesterol. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. After run-in, eligibility is confirmed with required laboratory tests at Day -1 prior to randomization. The eligible subjects are randomly assigned to CVI-LM001 100 mg, 200 mg, 300mg QD group or placebo QD group with ratio 1:1:1:1 to receive a 12-week double-blind treatment. After 12-week treatment, all investigational compound and placebo should be discontinued, followed by 4 week for safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100 mg | Experimental | Drug: 100 mg |
| 200 mg | Experimental | Drug: 200 mg |
| 300 mg | Experimental | Drug: 300 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Aged 18-70 years, inclusive
- 2. Men and nonpregnant, nonlactating women
- 3. Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L~4.88mmol/L at screening, inclusive
Key exclusion criteria (4 listed)
- 1. Fasting TG ≥3.99 mmol/L before randomization
- 2. History of significant cardiovascular , renal, pulmonary and liver diseases
- 3. History of diabetes
- 4. ALT or AST>1.5XULN at screening
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 |
|---|---|---|
| 100 mgOne 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks | Drug | 100 mg |
| 200 mgTwo 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks | Drug | 200 mg |
| 300 mgThree 100 mg pills (QD) will be orally administered for 12 weeks | Drug | 300 mg |
| PlaceboThree placebo pills (QD) will be orally administered for 12 weeks | Drug | Placebo |
Primary outcome
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: 12 weeks
The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events
Time frame: 12 weeks
Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment
8 secondary outcomes
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in Triglyceride (TG)
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a))
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Yes. lipid panel including LDL as well as safety data
Related trials for Hyperlipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.
Jingwen Liu, PhD contact
Que Liu, MDPhD study chair
CVI Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 100 mg, 200 mg and 300 mg in people with Hyperlipidemia, run by CVI Pharmaceuticals at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Que Liu, MD PhD (6194081058, que.liu@cvipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 23 Jun 2020.