At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two Part, Multicenter Phase IIa, Placebo Controlled Study, to Examine the Safety, Tolerability, and Effects of GSK256073 on Lipids in Subjects With Dyslipidemia
In Brief
A Phase 2 clinical trial evaluating GSK256073, Placebo, and 1 other intervention for Dyslipidaemias and Dyslipidemias. Completed, enrolled 80 participants across 11 sites.
Detailed Summary
This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the effect using the most relevant dose(s) (Part B: \~90 subjects). Doses of 5mg, 50mg and 150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease overall subject numbers needed in part B. Part B of the study will include a niaspan arm for relative comparison of the effects of GSK256073 and niacin on lipids and flushing
Study Details
Timeline
Interventions
5 mg for 8 weeks
50 mg for 8 weeks
150 mg for 8 weeks
placebo for 8 weeks
1500 mg for 8 weeks
x mg for 8 weeks based from data from Part A
optional dose based on data from Part A