NCT00677248

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Karo Bio AB · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Ezetimibe and placebo	Placebo or three different doses of eprotirome added to ezetimibe treatment
DRUG	Eprotirome and ezetimibe	Placebo or three different doses of eprotirome added to ezetimibe treatment

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-05-14
• Last updated: 2008-12-01

Locations

1 site across 1 country: Sweden