Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis
Summary
This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board (IEC/IRB) and the local regulatory authority.
Timeline
- Start
- 2019-06-12
- Primary completion
- 2020-03-20
- Completion
- 2020-03-20
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (other test); Saroglitazar Magnesium 2 mg vs Placebo; p = 0.7689; t-test, 2 sided reads as missed primary endpoint NCT03863574 ↗
registry analysis (other test); Saroglitazar Magnesium 4 mg vs Placebo; p = 0.6007; t-test, 2 sided reads as missed primary endpoint NCT03863574 ↗
release “Saroglitazar Magnesium has achieved the primary end -points in the EVIDENCES IV trial in patients with” reads as met primary endpoint zyduslife.com ↗
Publications
- Background Siddiqui MS, Parmar D, Sheikh F, Sarin SK, Cisneros L, Gawrieh S, Momin T, Duseja A, Sanyal AJ. Saroglitazar, a Dual PPAR alpha/gamma Agonist, Improves Atherogenic Dyslipidemia in Patients With Non-Cirrhotic Nonalcoholic Fatty Liver Disease: A Pooled Analysis. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2597-2605.e2. doi: 10.1016/j.cgh.2023.01.018. Epub 2023 Jan 31.
- Results Siddiqui MS, Idowu MO, Parmar D, Borg BB, Denham D, Loo NM, Lazas D, Younes Z, Sanyal AJ. A Phase 2 Double Blinded, Randomized Controlled Trial of Saroglitazar in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2670-2672. doi: 10.1016/j.cgh.2020.10.051. Epub 2020 Nov 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Saroglitazar | Small molecule | 2 mg | Oral |
| Subject | Saroglitazar | Small molecule | 4 mg | Oral |