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

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Hypertriglyceridemia
• Intervention / Treatment: Drug: ZYH7; Drug: ZYH7; Drug: ZYH7; Drug: Fenofibrate

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Room no 3027,Research block B,Department of Endocrinology PGIMER
  • Gujarat
    • Ahmedabad, Gujarat, India, 380007
      • Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi
    • Ahmedabad, Gujarat, India, 380008
      • Devi Hospital,Ground floor, Naranpura
    • Ahmedabad, Gujarat, India, 380009
      • Private clinic, 4, Stadium House, Ground Floor, Navrangpura
    • Ahmedabad, Gujarat, India, 380015
      • Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi
    • Bhavnagar, Gujarat, India, 364001
      • Govt. Medical College, Bhavnagar
    • Rajkot, Gujarat, India, 360001
      • Gastrocare Clinic,Ground floor, Karansinhji Main Road,
    • Vadodara, Gujarat, India, 390 023
      • Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura,
  • Karnataka
    • Bangalore, Karnataka, India, 560 043
      • Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi
    • Bangalore, Karnataka, India, 560085
      • Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage
    • Davangere, Karnataka, India, 577002
      • Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431001
      • Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station
    • Mumbai, Maharashtra, India, 400007
      • Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,
    • Pune, Maharashtra, India, 411005
      • Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House
  • Rajasthan
    • Jaipur, Rajasthan, India, 302024
      • Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632009
      • Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600094
      • Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Department of Endocrinology, Room No.9, 4 th Floor, Ronald Ross Building, Institute of Post Graduate Medical Education & Research, 244 AJC Bose Road.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ZYH7 4mg	Drug: ZYH7; ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.; Drug: ZYH7; ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.; Drug: ZYH7; ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
EXPERIMENTAL: ZYH7 8mg	Drug: ZYH7; ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.; Drug: ZYH7; ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.; Drug: ZYH7; ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
EXPERIMENTAL: ZYH7 16mg	Drug: ZYH7; ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.; Drug: ZYH7; ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.; Drug: ZYH7; ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
ACTIVE_COMPARATOR: Fenofibrate 160mg	Drug: Fenofibrate; Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.

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

Collaborators and Investigators

• Sponsor: Zydus Lifesciences Limited
• Investigators: Study Director: Rajendra H Jani, Ph.D (Medical), Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (ESTIMATE): February 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2013
• Last Update Submitted That Met QC Criteria: October 25, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Dyslipidemia; Hypertriglyceridemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: ZYH7.10.001.01; CTRI/2011/11/002147 (REGISTRY: Clinical Trials Registry - India)