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

Phase 2

Completed

• Conditions: Dyslipidemia; Hypertriglyceridemia
• Interventions: Drug: ZYH7; Drug: Fenofibrate

• Registration Number: NCT01539616
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

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

Exclusion Criteria

1. Pregnancy and lactation.
2. History of 5% weight loss in past 6 months.
3. Subjects on treatment with insulin and PPAR alpha or gamma agonist in the past 3 month.
4. Subjects having unstable angina, acute myocardial infarction in past 3 months or heart failure of New York Heart Association (NYHA) class (III-IV).
5. 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)
6. History of clinically significant edema.
7. History of pancreatitis or gall stone diseases.
8. 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.
9. Uncontrolled diabetes (HbA1c ≥ 9 gm %).
10. 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.
11. Renal dysfunction demonstrated by abnormal Glomerular Filtration Rate (GFR) (60 ml/min) or presence of ketonuria.
12. History of myopathies or evidence of active muscle diseases demonstrated by Creatinine Phosphokinase(CPK) ≥ 10 times UNL.
13. History of any other concurrent serious illness (e.g. tuberculosis, Human Immunodeficiency Virus(HIV) infection, malignancy, etc).
14. History of alcohol and/or drug abuse.
15. History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
16. Subjects on any other lipid lowering medications. (Appendix I).
17. If on contraceptive or hormone replacement therapy (HRT), therapy started or changed in last 3 months.
18. Prolonged use of steroids (15 days) in last 3 months (topical preparations, nasal and intra-articular administration are permitted).
19. History of long term use of non-steroidal anti-inflammatory drugs. (1 month)
20. Participation in any other clinical trial in the past 3 months
21. Unable to give informed consent and follow protocol requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZYH7 16mg	ZYH7	ZYH7 16mg
ZYH7 4mg	ZYH7	ZYH7 4mg
ZYH7 8mg	ZYH7	ZYH7 8mg
Fenofibrate 160mg	Fenofibrate	Fenofibrate 160mg

Primary Outcome Measures

Name	Time	Method
Percentage change in mean triglyceride level from baseline	4 and 8 weeks	Percentage change in mean triglyceride levels from baseline within and across each treatment of ZYH7 The changes will be compared with fenofibrate 160mg.

Secondary Outcome Measures

Name	Time	Method
Percentage change from baseline in lipid parameters	4 and 8 weeks	Percentage change from baseline in the following lipid parameters: 1. Low Density Lipoprotein Cholesterol(LDL); 2. Very Low Density Lipoprotein Cholesterol (VLDL); 3. High Density Lipoprotein (HDL); 4. Total cholesterol; 5. Non HDL Cholesterol (Measured value); 6. Apo A; 7. Apo B; 8. High sensitive C-Reactive Protein (hs-CRP)

Trial Locations

Locations (18)

Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road; 🇮🇳 Jaipur, Rajasthan, India

Gastrocare Clinic,Ground floor, Karansinhji Main Road,; 🇮🇳 Rajkot, Gujarat, India

Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,; 🇮🇳 Mumbai, Maharashtra, India

Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu; 🇮🇳 Chennai, Tamilnadu, India

Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi; 🇮🇳 Ahmedabad, Gujarat, India

Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House; 🇮🇳 Pune, Maharashtra, India

Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi; 🇮🇳 Bangalore, Karnataka, India

Devi Hospital,Ground floor, Naranpura; 🇮🇳 Ahmedabad, Gujarat, India

Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi; 🇮🇳 Ahmedabad, Gujarat, India

Private clinic, 4, Stadium House, Ground Floor, Navrangpura; 🇮🇳 Ahmedabad, Gujarat, India

Govt. Medical College, Bhavnagar; 🇮🇳 Bhavnagar, Gujarat, India

Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura,; 🇮🇳 Vadodara, Gujarat, India

Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage; 🇮🇳 Bangalore, Karnataka, India

Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,; 🇮🇳 Davangere, Karnataka, India

Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station; 🇮🇳 Aurangabad, Maharashtra, India

Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari; 🇮🇳 Vellore, Tamil Nadu, India

Room no 3027,Research block B,Department of Endocrinology PGIMER; 🇮🇳 Chandigarh, India

Department of Endocrinology, Room No.9, 4 th Floor, Ronald Ross Building, Institute of Post Graduate Medical Education & Research, 244 AJC Bose Road.; 🇮🇳 Kolkata, West Bengal, India