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Sponsored by: |
Karo Bio AB |
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Information provided by: | Karo Bio AB |
ClinicalTrials.gov Identifier: | NCT00593047 |
Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key enzymes involved in synthesis, degradation, and lipid transport. However, the currently marketed thyroid agonists are non-selective, and cannot be used for the treatment of hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on heart, bone, and muscle.
To take advantage of thyroid hormone effect on lipid metabolism for the treatment of hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective. The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to low and middle doses of statin following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 at doses between 25 and 100 µg and to define a clinically relevant dose or dose range for future studies.
Condition | Intervention | Phase |
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Dyslipidemia |
Drug: KB2115 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Placebo-Controlled, Double-Blind, Randomised, 12-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Statin Treatment in Patients With Dyslipidemia |
Estimated Enrollment: | 180 |
Study Start Date: | November 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Statin + placebo
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Drug: KB2115
tablet formulation given once daily for 12 weeks
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2: Experimental
Statin + KB2115 dose 1
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Drug: KB2115
tablet formulation given once daily for 12 weeks
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3: Experimental
Statin + KB2115 dose 2
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Drug: KB2115
tablet formulation given once daily for 12 weeks
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4: Experimental
Statin + KB2115 dose 3
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Drug: KB2115
tablet formulation given once daily for 12 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following:
Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization
Exclusion Criteria:
Responsible Party: | Karo Bio AB ( Dr Jens Kristensen, Chief Medical Officer ) |
Study ID Numbers: | KBT004, 2007-004413-33 |
Study First Received: | December 17, 2007 |
Last Updated: | November 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00593047 History of Changes |
Health Authority: | Sweden: Medical Products Agency; Finland: National Agency for Medicines |
hypercholesterolemia |
Metabolic Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Metabolic Disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Dyslipidemias Lipid Metabolism Disorders |