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

Karo Pharma

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Eprotirome and ezetimibe; Drug: Ezetimibe and placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00677248

2007-007831-24

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Ezetimibe and placebo

Treatment:

Drug: Ezetimibe and placebo

2

Experimental group

Description:

Eprotirome dose 1 and ezetimibe

Treatment:

Drug: Eprotirome and ezetimibe

3

Experimental group

Description:

Eprotirome dose 2 and ezetimibe

Treatment:

Drug: Eprotirome and ezetimibe

4

Experimental group

Description:

Eprotirome dose 3 and ezetimibe

Treatment:

Drug: Eprotirome and ezetimibe