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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Ezetimibe and placebo
* Drug: Eprotirome and ezetimibe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Ezetimibe and placebo | Drug: Ezetimibe and placebo<br>* Placebo or three different doses of eprotirome added to ezetimibe treatment<br>|
| Experimental: 2<br>Eprotirome dose 1 and ezetimibe | Drug: Eprotirome and ezetimibe<br>* Placebo or three different doses of eprotirome added to ezetimibe treatment<br>|
| Experimental: 3<br>Eprotirome dose 2 and ezetimibe | Drug: Eprotirome and ezetimibe<br>* Placebo or three different doses of eprotirome added to ezetimibe treatment<br>|
| Experimental: 4<br>Eprotirome dose 3 and ezetimibe | Drug: Eprotirome and ezetimibe<br>* Placebo or three different doses of eprotirome added to ezetimibe treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eprotirome, KB2115, dyslipidemia, hypercholesterolemia, hypertriglyceridemia