A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia

Inclusion criteria

• Age 18-65 years
• Subjects of either gender, males or females
• Triglycerides between 200 to 500 mg/dl on screening visit.
• Body mass index (BMI) > 23 kg/m2
• If subject is diabetic, he should be controlled on a maximum of two oral anti diabetic agents except Thiazolidinedione.
• Subject has given informed consent for participation in this trial.

Exclusion criteria

• Pregnancy and lactation.
• History of 5% weight loss in past 6 months.
• Subjects on treatment with insulin and PPAR alpha or gamma agonist in the past 3 month.
• Subjects having unstable angina, acute myocardial infarction in past 3 months or heart failure of New York Heart Association (NYHA) class (III-IV).
• Uncontrolled hypertension (150/100 mm of Hg).(If Subject using Thiazides, ACE inhibitors, beta blockers they should be on minimum 3 month stable therapy and treatment not expected to change during trial participation)
• History of clinically significant edema.
• History of pancreatitis or gall stone diseases.
• Subject having thyroid-stimulating hormone (TSH) levels outside normal reference range, Subjects who are clinically euthyroid and on stable thyroid replacement therapy for 2 months prior to screening and who are anticipated to remain on this dose throughout the trial period will be allowed.
• Uncontrolled diabetes (HbA1c ≥ 9 gm %).
• History of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and Alanine Aminotransferase(ALT) ≥ 2.5 times of upper normal limit (UNL) or bilirubin ≥ 2 times UNL in the past 3 months.
• Renal dysfunction demonstrated by abnormal Glomerular Filtration Rate (GFR) (60 ml/min) or presence of ketonuria.
• History of myopathies or evidence of active muscle diseases demonstrated by Creatinine Phosphokinase(CPK) ≥ 10 times UNL.
• History of any other concurrent serious illness (e.g. tuberculosis, Human Immunodeficiency Virus(HIV) infection, malignancy, etc).
• History of alcohol and/or drug abuse.
• History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
• Subjects on any other lipid lowering medications. (Appendix I).
• If on contraceptive or hormone replacement therapy (HRT), therapy started or changed in last 3 months.
• Prolonged use of steroids (15 days) in last 3 months (topical preparations, nasal and intra-articular administration are permitted).
• History of long term use of non-steroidal anti-inflammatory drugs. (1 month)
• Participation in any other clinical trial in the past 3 months
• Unable to give informed consent and follow protocol requirements.