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Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD）

NCT05795517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-04-09

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of HSK31679 tablets compared with placebo in reducing low-density lipoprotein cholesterol (LDL-C) and MRI-PDFF after 12 weeks of treatment in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).

Conditions

Interventions

DRUG

HSK31679 low dose

HSK31679 low dose and placebo of HSK31679 ，QD，oral，Day1 to week 12

DRUG

HSK31679 medium dose

HSK31679 medium dose and placebo of HSK31679 ，QD，oral，Day1 to week 12

DRUG

HSK31679 high dose

HSK31679 high dose and placebo of HSK31679 ，QD，oral，Day1 to week 12

DRUG

Placebo

placebo ，QD，oral，Day1 to week 12

DRUG

Ezetimibe 10mg

Ezetimibe 10mg+placebo of HSK31679 ，QD，oral，Day1 to week 12

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-02-20
Completion
2024-03-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795517 on ClinicalTrials.gov