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Completed

NCT Number: NCT00677248

LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe

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 clinical trials demonstrated pronounced reduction of several 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 add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a clinically relevant dose or dose range for future studies.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karo Bio AB

Huddinge, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged 18 to 75 years
  • Patient with primary hypercholesterolemia with an LDL-cholesterol > 3.0 mmol/L
  • At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study

Exclusion criteria

  • History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study

Treatment and study plan

Ezetimibe and placebo

Drug

Placebo or three different doses of eprotirome added to ezetimibe treatment

Eprotirome and ezetimibe

Drug

Placebo or three different doses of eprotirome added to ezetimibe treatment

Primary outcomes

  1. LDL cholesterol

    Time frame: 10 weeks

Secondary outcomes

  1. Triglycerides

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Karo Bio AB

Industry

Registry information

Official study title

A Phase II, Placebo-Controlled, Double-Blind, Randomised, 10-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Ezetimibe Treatment in Patients With Primary Hypercholesterolemia

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 14, 2008
Registry last updated
Dec 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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