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

Phase 2

Completed

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: Eprotirome; Drug: Placebo

• Registration Number: NCT00776321
• Lead Sponsor: Karo Bio AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-10
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-20
• Last Update Submitted: 2008-10-20
• Study First Posted: 2008-10-21
• Last Update Posted: 2008-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• clinical diagnosis of hypercholesterolemia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eprotirome dose 1	Eprotirome	-
1	Placebo	-
Eprotirome dose 2	Eprotirome	-

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	Week 12

Secondary Outcome Measures

Name	Time	Method
Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes	12 week

Trial Locations

Locations (1)

Jens Kristensen; 🇸🇪 Huddinge, Sweden