Pure Global
NCT05795517

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

A Phase 2 ,Multicentre, Randomised, Double Blind Double Simulation, Placebo and Positive Controlled Study to Evaluate the Efficacy and Safety of HSK31679 in Patients With Hypercholesterolemia With Non-alcoholic Fatty Liver Disease
Haisco Pharmaceutical Group Co., Ltd.·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hypercholesterolemia
Drug/Device/Intervention
HSK31679 low dose
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Haisco Pharmaceutical Group Co., Ltd.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 2
Start date
Apr 26, 2023
End date
Feb 08, 2024
Enrollment
200 participants
Primary outcome

Percentage change in LDL-C from baseline at 12 week;,Percentage change in MRI-PDFF from baseline at 12 week；

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).

ICD-10 classifications
Pure hypercholesterolaemiaLipoprotein deficiencyHyperglycaemia, unspecifiedDisorders of lipoprotein metabolism and other lipidaemiasOther disorders of lipoprotein metabolism
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05795517
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05795517 through Pure Global AI's free database. This Phase 2 trial is sponsored by Haisco Pharmaceutical Group Co., Ltd. and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 200 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.