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HypertriglyceridemiaPhase 2NCT01539616

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

A Phase 2 study testing ZYH7 and Fenofibrate in people with Hypertriglyceridemia and Dyslipidemia, run by Zydus Lifesciences Limited at 18 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypertriglyceridemia, Dyslipidemia
What is being tested?
ZYH7 and Fenofibrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
18 sitesIndia
Study dates
Nov 2011to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

India18 sites

  • Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi

    Ahmedabad, Gujarat, 380007

  • Devi Hospital,Ground floor, Naranpura

    Ahmedabad, Gujarat, 380008

  • Private clinic, 4, Stadium House, Ground Floor, Navrangpura

    Ahmedabad, Gujarat, 380009

  • Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi

    Ahmedabad, Gujarat, 380015

  • Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi

    Bangalore, Karnataka, 560 043

  • Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage

    Bangalore, Karnataka, 560085

  • Govt. Medical College, Bhavnagar

    Bhavnagar, Gujarat, 364001

  • Room no 3027,Research block B,Department of Endocrinology PGIMER

    Chandigarh, 160012

  • Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu

    Chennai, Tamil Nadu, 600094

  • Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station

    Chhatrapati Sambhajinagar, Maharashtra, 431001

  • Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,

    Davangere, Karnataka, 577002

  • Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road

    Jaipur, Rajasthan, 302024

  • 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, 700020

  • Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,

    Mumbai, Maharashtra, 400007

  • Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House

    Pune, Maharashtra, 411005

  • Gastrocare Clinic,Ground floor, Karansinhji Main Road,

    Rajkot, Gujarat, 360001

  • Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura,

    Vadodara, Gujarat, 390 023

  • Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari

    Vellore, Tamil Nadu, 632009

Other trials in India

About this study

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

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

Being tested
ZYH7, Fenofibrate
Keywords
Hypertriglyceridemia, Dyslipidemia
Medical subject headings
Hypertriglyceridemia, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZYH7Drug

    ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.

  • ZYH7Drug

    ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.

  • ZYH7Drug

    ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.

  • FenofibrateDrug

    Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.

Study groups in NCT01539616
Study groupRoleWhat they receive
ZYH7 4mgExperimentalZYH7 4mg
Receives: Drug: ZYH7
ZYH7 8mgExperimentalZYH7 8mg
Receives: Drug: ZYH7
ZYH7 16mgExperimentalZYH7 16mg
Receives: Drug: ZYH7
Fenofibrate 160mgActive comparatorFenofibrate 160mg
Receives: Drug: Fenofibrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 and 8 weeks

Secondary outcomes (1)

  1. Percentage change from baseline in lipid parameters

    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)

    Measured: 4 and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionJun 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01539616
Sponsor's protocol ID
ZYH7.10.001.01
Other IDs
CTRI/2011/11/002147
Status last verified
Oct 2013
First submitted
22 Feb 2012
Last updated
28 Oct 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZYH7 and Fenofibrate in people with Hypertriglyceridemia and Dyslipidemia, run by Zydus Lifesciences Limited at 18 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in mean triglyceride level from baseline (time frame: 4 and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01539616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013.

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