Clinical trial: A Pilot Study to Evaluate the Lipid Effects of TRIA-662 (NCT02008084)

Eligibility criteria:
Inclusion Criteria:

          1. Women of childbearing potential must have a negative serum pregnancy test at screening
             and Visit 4

             Women are considered not of childbearing potential if they:

               1. have had a hysterectomy or tubal ligation prior to Visit 1.

               2. are postmenopausal (12 months no menses or menopausal follicle stimulating
                  hormone level) Women of childbearing potential must agree to use an effective
                  method of birth control throughout the study. Acceptable means of birth control
                  include: implantable contraceptives, injectable contraceptives, oral
                  contraceptives, transdermal contraceptives, intrauterine devices, male or female
                  condoms with spermicide, abstinence, or a sterile sexual partner.

          2. Patients who at Weeks -4 and -2 demonstrate mean LDL-C at the levels at which
             lipid-modifying drug therapy is not indicated according to investigator judgment under
             ATP III guidelines.

          3. Patients who demonstrate mean serum triglycerides = or >200 mg/dL (2.26 mmol/L) but <
             or = 500 mg/dL (5.65 mmol/L) as measured at 2 sequential visits during the dietary
             controlled baseline period (Visits 2 and 3 or Visits 3 and 3a) and having lower level
             within 25% of upper level (higher value minus lower value)/higher value < 0.25).

          4. Patients willing to maintain a stable diet and physical activity level throughout the
             study

          5. Patients willing and able to sign the information and consent form and follow the
             protocol including availability for all visits/telephone follow-up for approximately
             24 weeks.

        Exclusion Criteria:

          1. pregnant, planning to become pregnancy during the study, or nursing

          2. clinically significant electrocardiographic abnormalities at Visit 1 or 4

          3. body mass index > 45 kg/m2 at Visit 1

          4. weight change of > 5% of initial body weight between Visit 1 and 4

          5. poorly controlled diabetes defined as a hemoglobin A1c > 9.5% prior to Visit 4

          6. evidence of hepatic disease (ALT or AST greater than 2.0 upper limit of normal (ULN),
             bilirubin > 1.5 ULN, or cirrhosis) at visit 1

          7. renal dysfunction defined as glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 at
             Visit 1

          8. hypothyroidism that is not treated or not stable for at least 6 months prior to study
             entry

          9. poorly controlled hypertension defined as a mean systolic blood pressure > 160 mm Hg
             and/or diastolic blood pressure > 100 mmHg at Visit 1. In individuals with end-organ
             damage, mean systolic blood pressure > 140 mmHg and mean diastolic blood pressure > 90
             mmHg at Visit 1

         10. severe hypotension defined as systolic blood pressure =< 90 mm Hg or diastolic blood
             pressure =< 60 mm Hg AND symptomatic

         11. active peptic ulcer

         12. known intolerance or allergy to niacin (nicotinic acid), niacinamide (nicotinamide),
             or any of the tablet ingredients: 1-methylnicotinamide chloride, microcrystalline
             cellulose, povidone, silicified microcrystalline cellulose, crospovidone, anhydrous
             dibasic calcium phosphate, hydroxypropyl cellulose, magnesium stearate (vegetable
             origin), polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol, methacrylic
             acid copolymer, and sodium bicarbonate.

         13. any known history of coronary artery disease, cerebrovascular disease or peripheral
             arterial disease

         14. Use after screening to the conclusion of the study of any of the following lipid
             modifying medications/supplements:

               1. Niacin (nicotinic acid) or niacinamide (nicotinamide)

               2. Fibrates/fibric acid derivatives like fenofibrate, gemfibrozil, clofibrate

               3. Bile acid sequestrants like cholestyramine, colesevelam, colestipol

               4. HMG-CoA reductase inhibitors (statins) including atorvastatin, cerivastatin,
                  fluvastatin, lovastatin, pravastatin, simvastatin, rosuvastatin

               5. Ezetimibe

               6. Omega-3 fatty acids

               7. Supplements containing flaxseed, tryptophan, fish oil, or algal oil.

               8. Sterol/stanol products

               9. Red yeast rice supplements or soy isoflavone supplements.

              10. Dietary fiber supplements including > 2 teaspoonfuls of Metamucil® or psyllium
                  containing supplements per day.

              11. Other natural health products or prescription agents judged by the investigator
                  to have the potential to alter serum lipid levels in an individual subject.

         15. history of angina or myocardial infarction

         16. hyperuricemia or with a history of gouty arthritis

         17. known nephritic syndrome or >3 g protein/day in urine at Visit 1

         18. known familial lipoprotein lipase deficiency, apo CII deficiency, or familial
             dysbetalipoproteinemia.

         19. requirement for peritoneal dialysis or hemodialysis for renal insufficiency.

         20. history of malignancy, except patients who have been disease-free for > 5 yrs, or
             resected basal or squamous cell skin carcinoma or cervical carcinoma in situ.

         21. history of bariatric surgery.

         22. history of pancreatitis, except secondary to cholelithiasis.

         23. anticipation of major surgery during the study.

         24. treatment with weight loss drugs or programs during the trial.

         25. treatment with HIV-protease inhibitors, cyclophosphamide or isotretinoin.

         26. treatment with tamoxifen, estrogens, or progestins that have not been stable for > 4
             week prior to screening at Visit 1

         27. routine or anticipated use of all systemic corticosteroids at Visit 1. Local, topical,
             inhaled, or nasal corticosteroids are permitted

         28. blood donation of > pint (0.5 L) within 30 days prior to screening, or plasma donation
             within 7 days prior to screening at Visit 1

         29. consumption of > 14 alcoholic drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5
             oz hard liquor) at Visit 1.

         30. history of drug abuse at Visit 1

         31. participation in another clinical trial within 30 days of signing the information and
             consent form.

         32. non-compliant to single blind investigational product (< 80% investigational product)
             or diet as per local judgment between Visit 1 and 4.

         33. Any condition or therapy that the investigator believes might pose a risk or make
             participation in the study not in the patient's best interest.

         34. Poor mental function or any reason to expect difficulty complying with the
             requirements of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? 0