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

This study has been completed.

First Received: October 17, 2008 Last Updated: October 20, 2008 History of Changes

Sponsor:	Karo Bio AB
Information provided by:	Karo Bio AB
ClinicalTrials.gov Identifier:	NCT00776321

Purpose

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.

Condition	Intervention	Phase
Primary Hypercholesterolemia	Drug: Eprotirome Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Placebo Controlled, Double Blind, Randomised, 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Karo Bio AB:

Primary Outcome Measures:

LDL cholesterol [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

Enrollment:	142
Study Start Date:	September 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo
Eprotirome dose 1: Experimental	Drug: Eprotirome
Eprotirome dose 2: Experimental	Drug: Eprotirome

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

clinical diagnosis of hypercholesterolemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776321

Locations

Sweden
Jens Kristensen
Huddinge, Sweden

Sponsors and Collaborators

Karo Bio AB

More Information

No publications provided

Responsible Party:	Karo Bio AB ( Jens Kristensen, MD PhD, Chief Medical Officer )
Study ID Numbers:	EudraCT No: 2006-003191-35
Study First Received:	October 17, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00776321 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Karo Bio AB:

hypercholesterolemia
dyslipidemia
thyroid
safety

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010