# Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

> **NCT07216235** · PHASE3 · NOT_YET_RECRUITING · sponsor: **Zydus Therapeutics Inc.** · enrollment: 386 (estimated)

## Conditions studied

- Primary Biliary Cholangitis

## Interventions

- **DRUG:** Saroglitazar magnesium 1 mg
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT07216235
- **Lead sponsor:** Zydus Therapeutics Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-02
- **Primary completion:** 2032-11
- **Final completion:** 2032-11
- **Target enrollment:** 386 (ESTIMATED)
- **Last updated:** 2026-02-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07216235

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07216235, "Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT07216235. Licensed CC0.

---

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