A Pilot Study to Evaluate the Lipid Effects of TRIA-662
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this pilot study is to learn what study factors are important in designing a
large, full-scale study of the effects of TRIA-662 on serum triglycerides (TG) and
high-density lipoprotein cholesterol (HDL-C) levels. In this study, patients will first enter
a Single-blind, dietary-controlled baseline period and receive 1000 mg placebo or active drug
three times daily with meals (i.e., breakfast, lunch, and dinner) for 6 - 8 weeks. If the
qualify to continue, they will then receive up to 2000 mg of active or placebo drug for an
additional 14 weeks. Active drug will be given to 48 patients and placebo drug will be given
to 16 patients. However, neither the patients not the clinic staff will know which patients
are on active or placebo drug until the end of the study.