A Pilot Study to Evaluate the Lipid Effects of TRIA-662
Condition: Hypertriglyceridemia; Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The primary objective of this pilot study is to assess the feasibility of a large,full-scale
      study that would evaluate the regulating 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. Upon
      completion of the 6 to 8 -week dietary-controlled baseline period, subjects meeting all
      inclusion and no exclusion criteria will be randomized to the double-blind treatment period.
      In the double-blind treatment period patients will be randomized such that at least 48
      subjects will be randomized to TRIA-662 and at least 16 patients will be randomized to
      placebo (3:1 ratio). The forced-dose titration will be achieved as follows: Weeks 1 - 2: Two
      500 mg tablets three times daily with meals (total daily dose 3000 mg); Weeks 3 - 14: Two
      1000 mg tablets three times daily with meals (total daily dose 6000 mg).

      Investigational product will be administered three times daily with meals (i.e., breakfast,
      lunch, and dinner). Down titration to 3000 mg daily (two 500 mg tablets, three times daily)
      is allowed in the event that a patient cannot tolerate the 6000 mg daily treatment for the
      stipulated period. Under this scenario, the down-titrated patient will remain on the
      tolerated dose for the remainder of the study. Lipid and ancillary exploratory parameters
      will be evaluated during the baseline period, upon randomization and throughout the active
      treatment period. Throughout the study, patients must adhere to a heart-healthy diet, abstain
      from/minimize ethyl alcohol intake and control any other variables that may alter serum lipid
      levels (e.g., exercise, weight loss programs, drugs including over the counter agents
      preparations that may alter serum lipid levels. Safety and tolerability will be assessed
      throughout the trial through the evaluation of physical exams, electrocardiograms (ECGs),
      routine hematology and blood chemistry testing, vital signs and adverse events.
    

Intervention name(s): TRIA-662; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Following Baseline randomized to active TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then active TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.; Following Baseline randomized to placebo TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then placebo TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hypertriglyceridemia; mixed hyperlipidemia