NCT03097107

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

Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm, 12-week Study 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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

SARO.15.001.04 is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel arm, 12-week study designed 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. A total 124 subjects will be enrolled in a ratio of 1:1:1:1 to receive either Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg, or placebo.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-06
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2017-03-31
• Last updated: 2023-02-08

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study