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Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL

NCT03097107 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-02-08

No results posted yet for this study

Summary

To evaluate the safety and efficacy of Saroglitazar Magnesium 1, 2, and 4 mg in patients with fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL.

Conditions

  • Dyslipidemias

Interventions

DRUG

Saroglitazar Magnesium 1 mg

Randomly assigned patients will receive saroglitazar magnesium 1 mg orally once each morning before breakfast for 12 weeks

DRUG

Saroglitazar Magnesium 2 mg

Randomly assigned patients will receive saroglitazar magnesium 2 mg orally once each morning before breakfast for 12 weeks

DRUG

Saroglitazar Magnesium 4 mg

Randomly assigned patients will receive saroglitazar magnesium 4 mg orally once each morning before breakfast for 12 weeks

DRUG

Placebo

Randomly assigned patients will receive placebo orally once each morning before breakfast for 12 weeks

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven V Parmar, MD · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2023-12-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03097107 on ClinicalTrials.gov