Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

Karo Pharma

Status and phase: Completed; Phase 2

Conditions: Primary Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Eprotirome

Study type: Interventional

Funder types: Industry

Identifiers

NCT00776321

EudraCT No: 2006-003191-35

Details and patient eligibility

About

Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors for the development of atherosclerotic cardiovascular diseases.

The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115.

Enrollment: 142 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• clinical diagnosis of hypercholesterolemia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

Eprotirome dose 1

Experimental group

Treatment:

Drug: Eprotirome

Eprotirome dose 2

Experimental group

Treatment:

Drug: Eprotirome