NCT03112681

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC). A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.

Detailed description

Study SARO.16.004.02 is a prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis. A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo. The primary objective is to investigate the effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on alkaline phosphatase (ALP) levels in patients with Primary Biliary Cholangitis.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Saroglitazar magnesium 2 mg	Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
DRUG	Saroglitazar magnesium 4 mg	Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
DRUG	Placebo Oral Tablet	Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.

Timeline

• Start date: 2017-08-18
• Primary completion: 2020-08-07
• Completion: 2020-08-07
• First posted: 2017-04-13
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study