A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia

NCT ID: NCT02087917

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-12-31

Brief Summary

To determine the efficacy of HS-25 (5, 10, 20 or 30 mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 4-week period of treatment in adults with primary hypercholesterolemia.

Detailed Description

This is a 4-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 130-189 mg/dL and fasting triglyceride levels < 350 mg/dL. Eligibility is restricted to 18-65 year 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.

Conditions

Primary Hypercholesterolemia

Study Design

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

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

HS-25 5 MG

Group Type: ACTIVE_COMPARATOR

HS-25

Intervention Type: DRUG

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

HS-25 10 MG

Group Type: ACTIVE_COMPARATOR

HS-25

Intervention Type: DRUG

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

HS-25 20 MG

Group Type: ACTIVE_COMPARATOR

HS-25

Intervention Type: DRUG

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

HS-25 30 MG

Group Type: ACTIVE_COMPARATOR

HS-25

Intervention Type: DRUG

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

Interventions

HS-25

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

Intervention Type: DRUG

Placebo

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men, or women using a highly effective birth control method or not of child-bearing potential, who are 18 to 65 years of age 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 15% 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
• Compliance of 80% to 120% with assigned study drug regimen during a 2 week placebo run-in phase.

Exclusion Criteria

• Women who are pregnant or breast feeding.
• History of stroke, myocardial infarction, unstable angina, heart failure or any arterial revascularization procedure (eg, carotid, coronary, aorta, peripheral arterial).
• History of diabetes or glycosylated hemoglobin (HbA1c) > 6.5.
• History of moderate to severe lactose intolerance (eg, unable to drink a glass of milk).
• History of hospitalization for treatment of a major psychiatric disorder.
• History of drug or alcohol abuse as defined by the Diagnostic and Statistical Manual (DSM-5) within the prior 12 months.
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months prior to screening.
• Hospitalization for a duration > 24 hours for any reason within the prior 3 months that, in the opinion of the investigator, may affect adherence to study procedures.
• History of a positive test for human immunodeficiency virus, hepatitis B or hepatitis C.
• History of cancer with the exception of well-treated basal cell or squamous cell carcinoma of skin, or in-situ cervical carcinoma.
• Presence of any condition which, in the opinion of the investigator, is likely to compromise completion of this trial or not be in the best interest of the subject.
• History of intolerance to ezetimibe.
• Participation in a prior study of HS 25.
• Participation in a study of an investigational drug or device within the prior 3 months unless subject has documentation of placebo administration in a placebo-controlled drug treatment trial only.
• Treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol, warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent within the prior 12 weeks.
• Anticipated need or frequent use of acetaminophen (> 2 gm/day, that is required > 4x/week).
• Vitamins, herbal and dietary supplements must be discontinued at screening unless subject has been on a long-term daily regimen and agrees to continue this regimen during the study.
• Alanine aminotransferase (ALT) > 1.0 × upper limit of normal (ULN) at Visit 1, Visit 2 or Visit 3.
• Aspartate aminotransferase (AST) > 1.0 × ULN at Visit 1, Visit 2 or Visit 3.
• Unexplained (not due to exercise or strenuous activity) creatinine kinase increase > 2 × ULN at Visit 1, Visit 2 or Visit 3.
• Estimated glomerular filtration rate (Modification of Diet in Renal Disease) < 60 mL/min/1.73m2 at Visit 1, Visit 2 or Visit 3.
• Thyroid stimulating hormone outside of the normal range.
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (eg, infectious disease) must not be enrolled.
• Any other laboratory abnormality considered by the investigator to be clinically significant.
• Any subject with an electrocardiogram (ECG) having a QTc interval ≥ 450 msec, or any other abnormality considered by the investigator to be clinically significant at the end of placebo run-in (Visit 3) should not be enrolled.

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

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Zhejiang Hisun Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Liao, PhD

Role: STUDY_DIRECTOR

Zhejiang Hisun Pharmaceuticals Co., Ltd

Locations

Chandler, Arizona, United States

Phoenix, Arizona, United States

West Hills, California, United States

Doral, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

South Miami, Florida, United States

Chicago, Illinois, United States

Evansville, Indiana, United States

Indianapolis, Indiana, United States

Overland Park, Kansas, United States

Louisville, Kentucky, United States

Auburn, Maine, United States

Bethesda, Maryland, United States

Methuen, Massachusetts, United States

Trenton, New Jersey, United States

Rochester, New York, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Tulsa, Oklahoma, United States

Penndel, Pennsylvania, United States

Greensboro, South Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HS-25-III

Identifier Type: -

Identifier Source: org_study_id