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

Primary Purpose

Hypercholesterolemia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HSK31679 low dose
HSK31679 medium dose
HSK31679 high dose
Placebo
Ezetimibe 10mg
Sponsored by
Haisco Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring hypercholesterolemia, non-alcoholic fatty liver disease(NAFLD), THR-β

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must be willing to participate in the study and provide written informed consent. Male or female aged 18 ≤ age < 65 at the time of signing the informed consent. 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). (BMI) ≥18kg/m2 and female subjects ≥45.0 kg and male subjects ≥50.0 kg. During screening, fasting triglyceride (TG) <5.65 mmol/L. During screening,MRI-PDFF≥8%. Weight changes≤5% in the 4 weeks prior to screening. Exclusion Criteria: 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. Homozygous familial hypercholesterolemia (HoFH) was diagnosed by genetic or clinical criteria. 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 Before screening, LDL-C plasma exchange was performed within 12 months. In the past, PCSK9 inhibitors, Lomitapide and Mipomersen were used for treatment. uncontrolled hypertension had systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg at screening/baseline. 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. 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. 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. Chronic systemic disease or history, including but not limited to Have a serious cardiopulmonary disease or history,Neurological disease or history,Autoimmune disease,Chronic digestive disease or history 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)) 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 Disease or medical history assessed by the investigator as likely to affect the study Bariatric surgery within 12 months at the time of screening

Sites / Locations

  • Tsinghua Changgeng in BeijingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

HSK31679 low dose

HSK31679 medium dose

HSK31679 high dose

Placebo

Ezetimibe

Arm Description

Outcomes

Primary Outcome Measures

Percentage change in LDL-C from baseline at 12 week;
Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 12 weeks of treatment;
Percentage change in MRI-PDFF from baseline at 12 week;
Percentage change of MRI-PDFF(change in liver fat content by nuclear magnetic resonance - Proton Density Fat Fraction) from baseline after 12 weeks of treatment;

Secondary Outcome Measures

Percentage change in fasting LDL-C from baseline;
Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 2, 4, and 8 weeks of treatment;
The proportion of patients with MRI-PDFF decreased by > 30%
After 12 weeks of treatment, the proportion of patients with MRI-PDFF decreased by > 30%;
Proportion of patients with LDL-C<3.34mmol/L(<130mg/dL)
After 12 weeks of treatment, the proportion of patients with LDL-C<3.34mmol/L(<130mg/dL)
Percentage change of fasting TG from baseline;
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting triglycerides (TG), from baseline;
Percentage change of fasting TC from baseline;
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting total cholesterol (TC) from baseline;
Percentage change of fasting HDL-C from baseline;
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting high-density lipoprotein cholesterol (HDL-C) from baseline;
Percentage change in body weight from baseline
Percentage change in body weight from baseline after 12 weeks of treatment.
AUC0-τ of HSK31679 (All subjects)
Cmax of HSK31679 (All subjects)

Full Information

First Posted
March 9, 2023
Last Updated
May 7, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05795517
Brief Title
Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease(NAFLD)
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
February 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
hypercholesterolemia, non-alcoholic fatty liver disease(NAFLD), THR-β

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HSK31679 low dose
Arm Type
Experimental
Arm Title
HSK31679 medium dose
Arm Type
Experimental
Arm Title
HSK31679 high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Ezetimibe
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HSK31679 low dose
Intervention Description
HSK31679 low dose and placebo of HSK31679 ,QD,oral,Day1 to week 12
Intervention Type
Drug
Intervention Name(s)
HSK31679 medium dose
Intervention Description
HSK31679 medium dose and placebo of HSK31679 ,QD,oral,Day1 to week 12
Intervention Type
Drug
Intervention Name(s)
HSK31679 high dose
Intervention Description
HSK31679 high dose and placebo of HSK31679 ,QD,oral,Day1 to week 12
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo ,QD,oral,Day1 to week 12
Intervention Type
Drug
Intervention Name(s)
Ezetimibe 10mg
Intervention Description
Ezetimibe 10mg+placebo of HSK31679 ,QD,oral,Day1 to week 12
Primary Outcome Measure Information:
Title
Percentage change in LDL-C from baseline at 12 week;
Description
Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 12 weeks of treatment;
Time Frame
Baseline and Week 12
Title
Percentage change in MRI-PDFF from baseline at 12 week;
Description
Percentage change of MRI-PDFF(change in liver fat content by nuclear magnetic resonance - Proton Density Fat Fraction) from baseline after 12 weeks of treatment;
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percentage change in fasting LDL-C from baseline;
Description
Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 2, 4, and 8 weeks of treatment;
Time Frame
Week2,4,8
Title
The proportion of patients with MRI-PDFF decreased by > 30%
Description
After 12 weeks of treatment, the proportion of patients with MRI-PDFF decreased by > 30%;
Time Frame
Baseline and Week 12
Title
Proportion of patients with LDL-C<3.34mmol/L(<130mg/dL)
Description
After 12 weeks of treatment, the proportion of patients with LDL-C<3.34mmol/L(<130mg/dL)
Time Frame
Baseline and Week 12
Title
Percentage change of fasting TG from baseline;
Description
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting triglycerides (TG), from baseline;
Time Frame
Week2,4,8,12
Title
Percentage change of fasting TC from baseline;
Description
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting total cholesterol (TC) from baseline;
Time Frame
Week2,4,8,12
Title
Percentage change of fasting HDL-C from baseline;
Description
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting high-density lipoprotein cholesterol (HDL-C) from baseline;
Time Frame
Week2,4,8,12
Title
Percentage change in body weight from baseline
Description
Percentage change in body weight from baseline after 12 weeks of treatment.
Time Frame
Baseline and Week 12
Title
AUC0-τ of HSK31679 (All subjects)
Time Frame
up to 2,4,7 weeks
Title
Cmax of HSK31679 (All subjects)
Time Frame
up to 2,4,7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be willing to participate in the study and provide written informed consent. Male or female aged 18 ≤ age < 65 at the time of signing the informed consent. 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). (BMI) ≥18kg/m2 and female subjects ≥45.0 kg and male subjects ≥50.0 kg. During screening, fasting triglyceride (TG) <5.65 mmol/L. During screening,MRI-PDFF≥8%. Weight changes≤5% in the 4 weeks prior to screening. Exclusion Criteria: 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. Homozygous familial hypercholesterolemia (HoFH) was diagnosed by genetic or clinical criteria. 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 Before screening, LDL-C plasma exchange was performed within 12 months. In the past, PCSK9 inhibitors, Lomitapide and Mipomersen were used for treatment. uncontrolled hypertension had systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg at screening/baseline. 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. 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. 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. Chronic systemic disease or history, including but not limited to Have a serious cardiopulmonary disease or history,Neurological disease or history,Autoimmune disease,Chronic digestive disease or history 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)) 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 Disease or medical history assessed by the investigator as likely to affect the study Bariatric surgery within 12 months at the time of screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fangqiong Li
Phone
+8602867258840
Email
lifangq@haisco.com
First Name & Middle Initial & Last Name or Official Title & Degree
lai wei
Phone
+8613501038098
Email
weelai@163.com
Facility Information:
Facility Name
Tsinghua Changgeng in Beijing
City
Beijing
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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