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Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease(NAFLD) - Trial NCT05795517

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.

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NCT05795517
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.govNCT05795517
View on ClinicalTrials.gov
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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

Study Focus

Hypercholesterolemia

HSK31679 low dose

Interventional

drug

Sponsor & Location

Haisco Pharmaceutical Group Co., Ltd.

Beijing, China

Timeline & Enrollment

Phase 2

Apr 26, 2023

Feb 08, 2024

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 hypercholesterolaemia
Lipoprotein deficiency
Hyperglycaemia, unspecified
Disorders of lipoprotein metabolism and other lipidaemias
Other disorders of lipoprotein metabolism

Data Source

ClinicalTrials.gov

NCT05795517

Non-Device Trial