A clinical trial to study the effects of ZYH1 and Fenofibrate in patients with high lipid levels.(Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS I).

A 12 week, randomized, double blind parallel group prospective dose ranging study of ZYH1 with an open fenofibrate arm to evaluate the efficacy on dyslipidemia in patients without diabetes. - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000164

Enrollment

Registered

2010-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Dyslipidemia without diabetes mellitus Health Condition 2: E785- Hyperlipidemia, unspecified

Interventions

Intervention1: ZYH1 0.5mg, 1mg, 2mg and 4mg: one tablet once daily of either 0.5mg, 1mg, 2mg or 4mg in the morning for the entire duration of the study i.e. for 12 weeks. Control Intervention1: Fenofi

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex ï?³18 years of age. Established diagnosis of dyslipidemia with BMI 23-42kg/m2 with fasting triglyceride level ï?³ 150mg/dL. Normal routine hematological and biochemical test results. Informed consent of the patient / relative

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to sulpha drugs or ZYH1 2.Pregnancy & Lactation. 3.Patients with the active liver disease or hepatic dysfunction indicated by AST or ALT levels > or = 2.5 times the upper limit of normal. 4.Patients with the history of myopathy or evidence of active muscle disease. 5.Haemoglobin less than 11mg% 6.Patients on concomitant medications known to affect the lipid levels and who does not want to enter in the wash out period. 7.Patients with uncontrolled diabetes mellitus (fasting blood sugar > or =110 mg/dL). 8.Patients with any other serious concurrent illness or malignancy. 9.Presence or history of the gall stone. 10.Patients with continuing history of alcohol and / or drug abuse. 11.Participation in another clinical trial in the past 3 months

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoints: 1.Triglyceride 2.Low density Lipoproteins ( LDL) cholesterol, 3.Very low density lipoprotein (VLDL) cholesterol, 4.HDL cholesterol and 5.Fasting Glucose.Timepoint: From baseline, visit 2(Week 0)to visit 8 (Week 12)	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: 1.HbA1C, 2.Insulin and 3.C-Reactive protein(CRP) Timepoint: From baseline, visit 2 (Week 0)to visit 8 (Week 12)	—

Countries

India

Contacts

Public ContactDr RHJani

Cadila Healthcare Limited

rhjani@zyduscadila.com91-22-26186052

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026