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

NCT ID: NCT05795517

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-26
• Study Completion Date: 2024-03-01

Brief 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

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HSK31679 low dose

Group Type: EXPERIMENTAL

HSK31679 low dose

Intervention Type: DRUG

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

HSK31679 medium dose

Group Type: EXPERIMENTAL

HSK31679 medium dose

Intervention Type: DRUG

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

HSK31679 high dose

Group Type: EXPERIMENTAL

HSK31679 high dose

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo ，QD，oral，Day1 to week 12

Ezetimibe

Group Type: ACTIVE_COMPARATOR

Ezetimibe 10mg

Intervention Type: DRUG

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

Interventions

HSK31679 low dose

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

Intervention Type: DRUG

HSK31679 medium dose

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

Intervention Type: DRUG

HSK31679 high dose

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

Intervention Type: DRUG

Placebo

placebo ，QD，oral，Day1 to week 12

Intervention Type: DRUG

Ezetimibe 10mg

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Must be willing to participate in the study and provide written informed consent.

2. Male or female aged 18 ≤ age < 65 at the time of signing the informed consent.

3. At the time of screening, patients who had not received lipid-regulation therapy within 6 weeks had fasting LDL-C≥3.34mmol/L（130mg/dL）.

4. (BMI) ≥18kg/m2 and female subjects ≥45.0 kg and male subjects ≥50.0 kg.

5. During screening, fasting triglyceride (TG) <5.65 mmol/L.

6. During screening,MRI-PDFF≥8%.

7. Weight changes≤5% in the 4 weeks prior to screening.

Exclusion Criteria

1. Did not discontinue any lipid-regulating therapy or any drug or supplement that may affect lipid levels 6 weeks before randomization or is expected to do so during the study period.

2. Homozygous familial hypercholesterolemia (HoFH) was diagnosed by genetic or clinical criteria.

3. Dyslipidemia caused by other diseases or drugs, such as rheumatoid arthritis, nephrotic syndrome, Cushing's syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen accumulation, myeloma, lipodystrophy, acute porphyria, polycystic ovarian syndrome, etc

4. Before screening, LDL-C plasma exchange was performed within 12 months.

5. In the past, PCSK9 inhibitors, Lomitapide and Mipomersen were used for treatment.

6. uncontrolled hypertension had systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg at screening/baseline.

7. type 1 diabetes, or newly diagnosed type 2 diabetes within 1 month, or poorly controlled type 2 diabetes, or who could not maintain the same hypoglycemic regimen during the study.

8. Stroke or transient ischemic attack (TIA), acute coronary syndrome, stable angina attack, severe deep vein thrombosis, or pulmonary embolism occurred in the 12 months prior to screening.

9. Major surgery (including but not limited to: coronary or other revascularization, coronary artery bypass surgery, and transplantation) within 12 months prior to screening or planned during the study period.

10. Chronic systemic disease or history, including but not limited to

1. Have a serious cardiopulmonary disease or history,Neurological disease or history,Autoimmune disease,Chronic digestive disease or history

2. Have thyroid disease or symptomatic abnormalities in thyroid function tests (e.g., thyroid stimulating hormone (TSH) < 1.0 x lower limit of normal (LLN) or > 1.5 x upper limit of normal (ULN))

3. History of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening

4. Disease or medical history assessed by the investigator as likely to affect the study

11. Bariatric surgery within 12 months at the time of screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tsinghua Changgung Hospital, Tsinghua University

Beijing, , China

Countries

China

References

Xue F, Ma W, Gao J, Chen J, Yue W, Bu P, Chen Q, Chen H, Sheng J, Chen L, Liu F, Li G, Zhu C, Zhong B, Zhang J, Cai Q, Wang L, Chen Y, Pei Z, Yao L, Lv L, Gao Y, Xia B, Ji X, Liu Y, Du L, Ma G, Hao K, Li F, Wu T, Huo Y, Wei L. Efficacy and Safety of HSK31679 in Asian Patients With MASLD: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Aug 20:S1542-3565(25)00703-7. doi: 10.1016/j.cgh.2025.08.009. Online ahead of print.

Reference Type: DERIVED

PMID: 40846146 (View on PubMed)

Other Identifiers

HSK31679-201

Identifier Type: -

Identifier Source: org_study_id