NCT03617263

Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)

Terminated Phase 2 Results posted Last updated 18 December 2025

What this trial tests

Phase 2 trial testing Saroglitazar Magnesium 4 mg Tablet in Non-alcoholic Fatty Liver Disease in Women With PCOS in 60 participants. Terminated before completion.

Timeline

12 February 2019

Primary endpoint
28 October 2024

28 October 2024

Quick facts

Lead sponsor	Zydus Therapeutics Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	12 February 2019
Primary completion	28 October 2024
Estimated completion	28 October 2024
Sites	19 locations across United States, Mexico

Drugs / interventions tested

• Saroglitazar Magnesium 4 mg Tablet
• Placebo

Conditions studied

• Non-alcoholic Fatty Liver Disease in Women With PCOS — all drugs for Non-alcoholic Fatty Liver Disease in Women With PCOS →

Sponsor

Zydus Therapeutics Inc. — full company profile →

Who can join

Adults 18 to 45, female only, with Non-alcoholic Fatty Liver Disease in Women With PCOS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hepatic Fat Content Primary · Baseline and Week 24

Change in hepatic fat content from baseline following 24 weeks of treatment as measured by Magnetic Resonance Imaging-derived Proton Density-fat Fraction (MRI-PDFF)

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-3.1741	± 1.01800
Placebo	-0.3499	± 1.06137

Liver Enzymes/Liver Function Tests Secondary · Baseline, Week 12, and Week 24

Changes from baseline to week 12 and week 24 in Alkaline phosphatase

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-22.64	± 1.954
Placebo	-3.91	± 2.083

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-20.07	± 2.520
Placebo	-1.66	± 2.627

Liver Enzymes/Liver Function Tests Secondary · Baseline, Week 12, and Week 24

Changes from baseline to week 12 and week 24 in Alanine aminotransferase

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-22.00	± 4.586
Placebo	-4.72	± 4.894

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-25.73	± 4.276
Placebo	-8.30	± 4.462

Liver Enzymes/Liver Function Tests Secondary · Baseline, Week 12, and Week 24

Changes from baseline to week 12 and week 24 in Aspartate Aminotransferase

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-9.97	± 4.233
Placebo	-3.31	± 4.514

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-11.27	± 4.437
Placebo	-2.88	± 4.627

Liver Enzymes/Liver Function Tests Secondary · Baseline, Week 12, and Week 24

Changes from baseline to week 12 and week 24 in gamma-glutamyl transferase

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-22.62	± 2.629
Placebo	-1.52	± 2.807

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-21.46	± 2.545
Placebo	-2.37	± 2.656

Liver Enzymes/Liver Function Tests Secondary · Baseline, Week 12, and Week 24

Changes from baseline to week 12 and week 24 in serum protein

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	0.01	± 0.072
Placebo	0.02	± 0.077

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-0.14	± 0.071
Placebo	0.03	± 0.074

Liver Enzymes/Liver Function Tests Secondary · Baseline, Week 12, and Week 24

Changes from baseline to week 12 and week 24 in albumin

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	1.06	± 0.477
Placebo	-0.39	± 0.510

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	0.06	± 0.485
Placebo	-0.15	± 0.507

Liver Enzymes/Liver Function Tests Secondary · Baseline, Week 12, and Week 24

Changes from baseline to week 12 and week 24 in total bilirubin.

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-0.076	± 0.0294
Placebo	-0.008	± 0.0313

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-0.066	± 0.0290
Placebo	-0.004	± 0.0302

Insulin Resistance Secondary · Baseline, Week 12, and Week 24

Evaluation of HOMA of Insulin Resistance Index determines insulin resistance and estimates insulin sensitivity, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance

Week 12

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-1.983	± 1.2192
Placebo	1.081	± 1.3004

Week 24

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	0.498	± 2.1910
Placebo	4.303	± 2.2852

Liver Injury Secondary · Baseline and Week 24

Changes from baseline to week 24 in Liver Injury, including Cytokeratin (CK)-18. CK18 \[M30\] and CK-18 \[M-65\] were measured as biomarkers of hepatocyte apoptosis. Both are important indicators for liver tissue conditions and effectively reflect hepatocyte damage. A negative change from baseline indicates a decrease in hepatocyte apoptosis or a decrease in hepatocyte damage.

M30

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-238.801	± 69.9009
Placebo	-92.160	± 72.8890

M65

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-260.232	± 100.6148
Placebo	-72.273	± 104.9207

Liver Injury Secondary · Baseline and Week 24

Changes from baseline to week 24 in high-sensitivity C-reactive protein (hs-CRP)

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	-1.00	± 1.381
Placebo	0.55	± 1.440

Liver Injury Secondary · Baseline and Week 24

Changes from baseline to week 24 in Tumor necrosis factor (TNFα)

Group	Value	95% CI
Saroglitazar Magnesium 4 mg	0.109	± 0.2711
Placebo	0.587	± 0.2827

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Saroglitazar Magnesium 4 mg

Serious: 0/30 (0%)

Deaths: 0/30

Placebo

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (21 terms — click to expand)

Reaction	System	Saroglitazar Magnesium 4 mg	Placebo
Headache	Nervous system disorders	—	—
General disorders and administration site conditions	General disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Gastritis	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Anxiety	Psychiatric disorders	—	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Sinusitis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Covid-19	Infections and infestations	—	—
Dysmenorrhea	Reproductive system and breast disorders	—	—
Heavy menstrual bleeding	Reproductive system and breast disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
ALT increased	Investigations	—	—
AST increased	Investigations	—	—

Data from ClinicalTrials.gov NCT03617263 adverse events section.

Sponsor's own description

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploration and Development of PPAR Modulators in Health and Disease: An Update of Clinical Evidence.
   Cheng HS, Tan WR, Low ZS, Marvalim C, et al · · 2019 · cited 196× · PMID 31614690 · DOI 10.3390/ijms20205055
2. PPAR Alpha as a Metabolic Modulator of the Liver: Role in the Pathogenesis of Nonalcoholic Steatohepatitis (NASH).
   Todisco S, Santarsiero A, Convertini P, De Stefano G, et al · · 2022 · cited 85× · PMID 35625520 · DOI 10.3390/biology11050792
3. Transcriptional Regulation of Metabolic Pathways via Lipid-Sensing Nuclear Receptors PPARs, FXR, and LXR in NASH.
   Cariello M, Piccinin E, Moschetta A. · · 2021 · cited 71× · PMID 33545430 · DOI 10.1016/j.jcmgh.2021.01.012
4. PPAR-Targeted Therapies in the Treatment of Non-Alcoholic Fatty Liver Disease in Diabetic Patients.
   Lange NF, Graf V, Caussy C, Dufour JF. · · 2022 · cited 52× · PMID 35457120 · DOI 10.3390/ijms23084305
5. Current Clinical Trial Status and Future Prospects of PPAR-Targeted Drugs for Treating Nonalcoholic Fatty Liver Disease.
   Kamata S, Honda A, Ishii I. · · 2023 · cited 42× · PMID 37627329 · DOI 10.3390/biom13081264
6. PPAR agonists for the treatment of primary biliary cholangitis: Old and new tales.
   Colapietro F, Gershwin ME, Lleo A. · · 2023 · cited 41× · PMID 36684809 · DOI 10.1016/j.jtauto.2023.100188
7. Obesity, non-alcoholic fatty liver disease and hepatocellular carcinoma: current status and therapeutic targets.
   Chen Y, Wang W, Morgan MP, Robson T, et al · · 2023 · cited 37× · PMID 37361533 · DOI 10.3389/fendo.2023.1148934
8. MetALD: Does it require a different therapeutic option?
   Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935