Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol
 (LDL-C) levels after a 12-week period of treatment in adults with primary
 hypercholesterolemia;

 To determine the safety of HS-25 (20mg) in subjects with LDL-C
This is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the
 effects of the cholesterol absorption inhibitor HS-25 on LDL-C levels in adults who have
 untreated LDL-C levels ranging from 3.36-4.88mmol/L(130-189 mg/dL)and fasting triglyceride
 levels < 350 mg/dL. Eligibility is restricted to 18-75 years old men or women who are using a
 highly effective birth control method or are not of childbearing potential. Patients with
 diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic
 vascular disease are not eligible for participation in the study.
Inclusion Criteria:

 -  Subjects who are 18 to 75 years of age, male or female using a highly effective birth
 control method or not of child-bearing potential, at Visit 1 (screening visit).

 -  LDL-C 130 to 189 mg/dL (inclusive) on a cholesterol lowering diet but no lipid
 modifying drug treatment for at least 6 weeks.

 -  A qualifying LDL-C value must be obtained at the beginning and end of the placebo
 run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at
 Visit 2, higher or lower; the average of both qualifying values must be in the range
 of 130 to 189 mg/dL (inclusive) for inclusion in the study.

 -  TG ≤ 350 mg/dL on a cholesterol lowering diet but no lipid modifying drug treatment
 for at least 6 weeks and TG levels must be ≤ 350 mg/dL at both Visit 2 and Visit 3

 -  Signed written informed consent.

 Exclusion Criteria:

 -  Liver transaminases > 1.5 x upper limit of normal.

 -  Homozygous Familial Hypercholesterolemia.

 -  Subject who was diagnosed as diabetes with aged greater than 40 years old.

 -  Subject who was diagnosed as diabetes with one of the following of cardiovascular risk
 factorss: Hypertention Bp ≥ 140/90mmHg,or smoking, or low HDL-C (1.04mmol/L), or
 BMI≥28kg/m2.

 -  Women who are pregnant or breast feeding.

 -  Atherosclerotic cardiovascular disease including Arteriosclerotic heart disease, Acute
 coronary syndrome，Coronary artery bypass graft,Coronary angioplastyPeripheral
 arteriosclerosis,Cerebrovascular accident

 -  history of Severe Endiocrine disease (for example Thyroid function abnormal)

 -  History of a positive test for human immunodeficiency virus, hepatitis B or hepatitis
 C.

 -  History of advanced cancer

 -  Arrhythmias need to be treated by medications

 -  Had severe injured or surgery in 6 months before study start.

 -  Hypersensitive to HS-25 or place.

 -  History of intolerance to ezetimibe.

 -  Participation other studies in three months.

 -  Treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol,
 warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent
 within the prior 12 weeks.