Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

NCT04438096 | Unknown Phase 2

• 1 other identifier: CVI-LM001-Ⅱ-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 weeks

Secondary Outcomes (8)

• Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

  12 weeks

• Percent Change From Baseline to Week 12 in Total Cholesterol (TC)

  12 weeks

• Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)

  12 weeks

• Percent Change From Baseline to Week 12 in Triglyceride (TG)

  12 weeks

• Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)

  12 weeks

Study Arms (4)

100 mg

EXPERIMENTAL

Drug: 100 mg

200 mg

EXPERIMENTAL

Drug: 200 mg

300 mg

EXPERIMENTAL

Drug: 300 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

100 mg DRUG

One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks

100 mg

200 mg DRUG

Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks

200 mg

300 mg DRUG

Three 100 mg pills (QD) will be orally administered for 12 weeks

300 mg

Placebo DRUG

Three placebo pills (QD) will be orally administered for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18-70 years, inclusive
• \. Men and nonpregnant, nonlactating women
• \. Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L\~4.88mmol/L at screening, inclusive

You may not qualify if:

• \. Fasting TG ≥3.99 mmol/L before randomization
• \. History of significant cardiovascular , renal, pulmonary and liver diseases
• \. History of diabetes
• \. ALT or AST\>1.5XULN at screening

Sponsors & Collaborators

• CVI Pharmaceuticals: lead

Study Sites (1)

The second affiliated hospital of zhejiang University school of medicine

Hangzhou, 310009, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Que Liu, MDPhD

  CVI Pharmaceuticals

  STUDY CHAIR

Central Study Contacts

Que Liu, MD PhD

CONTACT

6194081058; que.liu@cvipharma.com

Jingwen Liu, PhD

CONTACT

jingwen.liu2@cvipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: July 15, 2020
• Primary Completion: December 15, 2021
• Study Completion: March 15, 2022
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: July, 2021

Locations

CN (1)