Clinical Trial: A Pilot Study to Evaluate the Lipid Effects of TRIA-662

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, Forced Dose-escalation, Multi-center Pilot Study to Evaluate the Lipid Regulating Effects of TRIA-662 (1-methylnicotinamide Chloride)

Brief 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 Summary:

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 tha
Sponsor: Cortria Corporation

Current Primary Outcome:

• Recruitment Rate [ Time Frame: 12 months ]
  The number of patients randomized per site per month during the study
• Compliance to investigational product [ Time Frame: 14 weeks ]
  The proportion of randomized patients receiving the investigational product as per protocol.
• Completion rate [ Time Frame: 12 months ]
  The proportion of randomized patients completing the 14-week follow-up.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Effect on serum high-density lipoprotein cholesterol (HDL-C) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in serum HDL-C.
• Variability of serum triglycerides [ Time Frame: 14 weeks ]
  The standard deviation of the change from baseline to end of study in serum triglycerides.
• Effect on fasting glucose [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in fasting glucose.
• Effect on C-reactive protein [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in C-reactive protein.
• Effect on interleukin-6 (IL-6) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in IL-6.
• Effect on total cholesterol (TC) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in TC
• Effect on low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in LDL-C
• Effect on very low-density lipoprotein cholesterol (VLDL-C) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in (VLDL-C),
• Effect on total apolipoprotein B (apoB) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in apoB
• Effect on total apolipoprotein A1 (apoA1) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in apoA1
• Effect on lipoprotein (a) [Lp(a)] [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in Lp(a)
• Effect on non-high density lipoprotein cholesterol (non-HDL-C) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in non-HDL-C
• Effect on TG/HDL-C ratio [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in TG/HDL-C ratio
• Effect on tumor necrosis factor - alpha (TNF-α) [ Time Frame: 14 weeks ]
  The difference between groups in change from baseline to end of study in TNF-α

Original Secondary Outcome: Same as current

Information By: Cortria Corporation

Dates:
Date Received: December 6, 2013
Date Started: December 2013
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016