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

Karo Bio AB120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Hypercholesterolemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

LDL cholesterol

Time frame: 10 weeks

Secondary Outcomes

Triglycerides