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

Study Overview
=================
Brief Summary
-----------------
ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to decrease triglyceride level and also correct dyslipidemia.

Official Title
-----------------
A Multicentric Prospective Randomized Double Blind Parallel Group Active Controlled Study to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia

Conditions
-----------------
Hypertriglyceridemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: ZYH7
* Drug: ZYH7
* Drug: ZYH7
* Drug: Fenofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZYH7 4mg<br>ZYH7 4mg | Drug: ZYH7<br>* ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.<br>|
| Experimental: ZYH7 8mg<br>ZYH7 8mg | Drug: ZYH7<br>* ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.<br>|
| Experimental: ZYH7 16mg<br>ZYH7 16mg | Drug: ZYH7<br>* ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.<br>|
| Active Comparator: Fenofibrate 160mg<br>Fenofibrate 160mg | Drug: Fenofibrate<br>* Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in mean triglyceride level from baseline | Percentage change in mean triglyceride levels from baseline within and across each treatment of ZYH7 The changes will be compared with fenofibrate 160mg. | 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in lipid parameters | Percentage change from baseline in the following lipid parameters: Low Density Lipoprotein Cholesterol(LDL) Very Low Density Lipoprotein Cholesterol (VLDL) High Density Lipoprotein (HDL) Total cholesterol Non HDL Cholesterol (Measured value) Apo A Apo B High sensitive C-Reactive Protein (hs-CRP) | 4 and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertriglyceridemia, Dyslipidemia