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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.
Information provided by:
Karo Bio AB Identifier:
First received: October 17, 2008
Last updated: October 20, 2008
Last verified: October 2008

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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:

Further study details as provided by Karo Bio AB:

Primary Outcome Measures:
  • LDL cholesterol [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes [ Time Frame: 12 week ]

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
Placebo Comparator: 1 Drug: Placebo
Experimental: Eprotirome dose 1 Drug: Eprotirome
Other Name: KB2115
Experimental: Eprotirome dose 2 Drug: Eprotirome
Other Name: KB2115


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical diagnosis of hypercholesterolemia
  Contacts and Locations
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Please refer to this study by its identifier: NCT00776321

Jens Kristensen
Huddinge, Sweden
Sponsors and Collaborators
Karo Bio AB
  More Information

Responsible Party: Jens Kristensen, MD PhD, Chief Medical Officer, Karo Bio AB Identifier: NCT00776321     History of Changes
Other Study ID Numbers: EudraCT No: 2006-003191-35
Study First Received: October 17, 2008
Last Updated: October 20, 2008

Keywords provided by Karo Bio AB:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on April 28, 2017