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

> **NCT03112681** · PHASE2 · COMPLETED · sponsor: **Zydus Therapeutics Inc.** · enrollment: 37 (actual)

## Conditions studied

- Primary Biliary Cirrhosis

## Interventions

- **DRUG:** Saroglitazar magnesium 2 mg
- **DRUG:** Saroglitazar magnesium 4 mg
- **DRUG:** Placebo Oral Tablet

## Key facts

- **NCT ID:** NCT03112681
- **Lead sponsor:** Zydus Therapeutics Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-08-18
- **Primary completion:** 2020-08-07
- **Final completion:** 2020-08-07
- **Target enrollment:** 37 (ACTUAL)
- **Last updated:** 2024-09-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03112681

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03112681, "Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT03112681. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*