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

NCT02087917 | Completed Phase 2

• 1 other identifier: HS-25-III
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 27

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.

Conditions

Primary Hypercholesterolemia

Keywords

hypercholesterolemia; cholesterol absorption inhibitor; placebo-controlled trial

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in LDL-C after 4 weeks of double-blind treatment

  4 weeks

Secondary Outcomes (5)

• Percentage of participants with reported adverse events during a 4-week period of treatment as a measure of safety and tolerability of HS-25

  4 weeks

• Percent change from baseline in LDL-C after a 1 and 2-week period of double-blind treatment

  1- and 2-weeks

• Percent change from baseline in apoprotein B, non-high density lipoprotein-cholesterol, total cholesterol, triglycerides, high density lipoprotein-cholesterol and apoprotein A1 levels after a 1, 2 and 4-week period of treatment

  1-, 2- and 4-week periods

• Mean concentration of HS-25 dose and its major metabolite (HS-25-M1) during treatment with HS-25 5, 10, 20 or 30 mg.

  1-, 2- and 4-week

• Correlation between trough HS-25 and HS-25-M1 levels and percent change in LDL-C, apoA1, apoB, non-HDL-C, TC, TG, and HDL-C during a 4-week period of HS-25 treatment.

  1-, 2- and 4-week

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

HS-25 5 MG

ACTIVE COMPARATOR

Drug: HS-25

HS-25 10 MG

ACTIVE COMPARATOR

Drug: HS-25

HS-25 20 MG

ACTIVE COMPARATOR

Drug: HS-25

HS-25 30 MG

ACTIVE COMPARATOR

Drug: HS-25

Interventions

HS-25 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; HS-25 20 MG; HS-25 30 MG; HS-25 5 MG

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Hisun Pharmaceutical Co. Ltd.: lead
• Covance: collaborator

Study Sites (27)

Unknown Facility

Chandler, Arizona, 85224, United States

Location

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Phoenix, Arizona, United States

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West Hills, California, United States

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Doral, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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South Miami, Florida, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Auburn, Maine, United States

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Bethesda, Maryland, United States

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Methuen, Massachusetts, United States

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Trenton, New Jersey, United States

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Rochester, New York, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Tulsa, Oklahoma, United States

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Penndel, Pennsylvania, United States

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Greensboro, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kevin Liao, PhD

  Zhejiang Hisun Pharmaceuticals Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 14, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

US (27)