NCT04446507 is a Phase 1 clinical trial of Saroglitazar magnesium in Renal Impairment, sponsored by Zydus Therapeutics Inc..

Who is sponsoring NCT04446507?

NCT04446507 is sponsored by Zydus Therapeutics Inc..

What drugs are being tested in NCT04446507?

Interventions in NCT04446507: Saroglitazar magnesium.

What condition does NCT04446507 study?

NCT04446507 studies Renal Impairment.

Is NCT04446507 still recruiting?

NCT04446507 is currently completed. Last updated 20 September 2024.

Last reviewed 2024-09-20 · How we verify

NCT04446507

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function

Completed Phase 1 Last updated 20 September 2024

What this trial tests

Phase 1 trial testing Saroglitazar magnesium in Renal Impairment in 32 participants. Completed in 28 May 2024.

Timeline

27 July 2020

Primary endpoint
28 May 2024

28 May 2024

Quick facts

Lead sponsor	Zydus Therapeutics Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	32
Start date	27 July 2020
Primary completion	28 May 2024
Estimated completion	28 May 2024
Sites	2 locations across United States

Drugs / interventions tested

Saroglitazar magnesium — full drug profile →

Conditions studied

Renal Impairment — all drugs for Renal Impairment →

Sponsor

Zydus Therapeutics Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacokinetic, Safety, and Pharmacodynamic Profiles of Saroglitazar Magnesium in Cholestatic Cirrhosis With Hepatic Impairment and Participants With Renal Impairment.
Vuppalanchi R, Cruz MM, Momin T, Shaikh F, et al · · 2025 · cited 6× · PMID 39355940 · DOI 10.1002/cpt.3450

Verify or expand the search:

Other trials of Saroglitazar magnesium

Trials testing the same drug.

NCT04112446 — Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects · Phase 1 · completed

Other recruiting trials for Renal Impairment

Currently open trials in the same condition.

NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting

Other Zydus Therapeutics Inc. trials

Trials by the same sponsor.

NCT06825559 — Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease · Phase 1 · recruiting
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

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04446507 (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: 20 September 2024

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/NCT04446507.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing