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NCT06825559
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Phase 1 trial testing Saroglitazar Magnesium 1 mg in Cholestatic Liver Disease in 6 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Zydus Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 5 August 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Saroglitazar Magnesium 1 mg — full drug profile →
Conditions studied
- Cholestatic Liver Disease — all drugs for Cholestatic Liver Disease →
Sponsor
Zydus Therapeutics Inc. — full company profile →
Who can join
Adults 18 to 80, any sex, with Cholestatic Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Primary biliary cholangitis. Treatment options in 2025. A narrative review.
Angelara M, Papachristou K, Papatheodoridi M, Nasiri-Ansari N, et al · · 2025 · cited 1× · PMID 41256868 · DOI 10.3389/fimmu.2025.1698833
Verify or expand the search:
- PubMed search for NCT06825559
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Saroglitazar Magnesium 1 mg
Trials testing the same drug.
- NCT06427395 — Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
- NCT05133336 — Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis · Phase 2, PHASE3 · completed
- NCT05045482 — Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease · Phase 1 · recruiting
Other recruiting trials for Cholestatic Liver Disease
Currently open trials in the same condition.
- NCT07317193 — DEFINING THE GENETIC DRIVERS OF ADULT-ONSET CHOLESTATIC LIVER DISEASE · NA · recruiting
- NCT05045482 — Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease · Phase 1 · recruiting
Other Zydus Therapeutics Inc. trials
Trials by the same sponsor.
- NCT06427395 — Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
- NCT05211284 — Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US · Phase 2 · terminated
- NCT05133336 — Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis · Phase 2, PHASE3 · completed
- NCT05045482 — Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease · Phase 1 · recruiting
- NCT05011305 — Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06825559 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zydus Therapeutics Inc.
- Last refreshed: 24 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06825559.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing