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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
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.
Crowfoot Village Family Practice
Calgary, Alberta, Canada
Dr. Senaratne Professional Corporation
Edmonton, Alberta, Canada
The Bailey Clinic
Red Deer, Alberta, Canada
Manna Research Vancouver
Vancouver, British Columbia, Canada
GA Research Associates, Ltd
Moncton, New Brunswick, Canada
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, Canada
Scisco Clinical Research
Cornwall, Ontario, Canada
Sameh Fikry Medicine Professional Corp
Kitchener, Ontario, Canada
Aging, Rehabilitation & Geriatric Care, Lawson Health Research Institute-St Joseph's Health Care, Parkwood
London, Ontario, Canada
Prime Health Clinical Research
Toronto, Ontario, Canada
...and 7 more locations
Recruitment Rate
The number of patients randomized per site per month during the study
Time frame: 12 months
Compliance to investigational product
The proportion of randomized patients receiving the investigational product as per protocol.
Time frame: 14 weeks
Completion rate
The proportion of randomized patients completing the 14-week follow-up.
Time frame: 12 months
Effect on serum high-density lipoprotein cholesterol (HDL-C)
The difference between groups in change from baseline to end of study in serum HDL-C.
Time frame: 14 weeks
Variability of serum triglycerides
The standard deviation of the change from baseline to end of study in serum triglycerides.
Time frame: 14 weeks
Effect on fasting glucose
The difference between groups in change from baseline to end of study in fasting glucose.
Time frame: 14 weeks
Effect on C-reactive protein
The difference between groups in change from baseline to end of study in C-reactive protein.
Time frame: 14 weeks
Effect on interleukin-6 (IL-6)
The difference between groups in change from baseline to end of study in IL-6.
Time frame: 14 weeks
Effect on total cholesterol (TC)
The difference between groups in change from baseline to end of study in TC
Time frame: 14 weeks
Effect on low-density lipoprotein cholesterol (LDL-C)
The difference between groups in change from baseline to end of study in LDL-C
Time frame: 14 weeks
Effect on very low-density lipoprotein cholesterol (VLDL-C)
The difference between groups in change from baseline to end of study in (VLDL-C),
Time frame: 14 weeks
Effect on total apolipoprotein B (apoB)
The difference between groups in change from baseline to end of study in apoB
Time frame: 14 weeks
Effect on total apolipoprotein A1 (apoA1)
The difference between groups in change from baseline to end of study in apoA1
Time frame: 14 weeks
Effect on lipoprotein (a) [Lp(a)]
The difference between groups in change from baseline to end of study in Lp(a)
Time frame: 14 weeks
Effect on non-high density lipoprotein cholesterol (non-HDL-C)
The difference between groups in change from baseline to end of study in non-HDL-C
Time frame: 14 weeks
Effect on TG/HDL-C ratio
The difference between groups in change from baseline to end of study in TG/HDL-C ratio
Time frame: 14 weeks
Effect on tumor necrosis factor - alpha (TNF-α)
The difference between groups in change from baseline to end of study in TNF-α
Time frame: 14 weeks
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