Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis, Fibrosis

In brief

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Key facts

Study ID

NCT05011305

Run by

Zydus Therapeutics Inc.

People needed

189

Starts

2021-08-18

Expected to finish

2025-09-12

Last updated by the study team

2025-10-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, between 18 and 75 years of age, both inclusive at screening.
• BMI ≤45 kg/m²
• Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥4 with at least one-point score in each of the three components of the NAFLD activity score [NAS] (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3) and NASH by pattern recognition Note: The biopsy must not have been performed more than 24 weeks before randomization.
• The subjects must have a stable body weight (no more than 5% change) between the time of biopsy and randomization.
• Fibrosis stage 2 and 3, according to the NASH CRN fibrosis staging, reported by central pathologist.
• If the subjects have type 2 diabetes mellitus, then it must be moderately controlled with HbA1c ≤ 9.5% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening until randomization.
• If the subjects are taking vitamin E > 400 IU/day, then it must be on a stable dose for at least 24 weeks prior to screening or, if a historical biopsy is used, at least 24 weeks prior to baseline liver biopsy until randomization.
• Must provide written informed consent and agree to comply with the trial protocol.

You may not qualify if…

• Consumption of >2 units of alcohol per day (>14 units per week) if male and >1 units of alcohol per day (>7 units per week) if female for at least 12 consecutive weeks within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor)
• History or presence of other concomitant liver diseases at screening:
• Chronic hepatitis B (HBV) or hepatitis C virus (HCV) infection (However, If the subject has been treated for the HCV infection and has been cured at least 5 years from screening, such subjects can be enrolled in the study)
• Primary biliary cholangitis (PBC)
• Primary sclerosing cholangitis (PSC)
• Definite autoimmune liver disease or overlap syndrome
• Alcoholic liver disease
• Hemochromatosis
• Wilsons disease
• Alpha-1 antitrypsin deficiency
• Subject with known cirrhosis, either based on histology, clinical criteria or any non-invasive diagnostic modality, within 24 weeks prior to the randomization.
• Evidence of portal hypertension (low platelet count, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly) at screening.
• Treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium glucose cotransporter- 2 (SGLT-2) inhibitors, and dipeptidyl peptidase 4 inhibitors (gliptins) unless stable for 120 days prior to screening or, if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.
• Use of concurrent medications prior to screening including:
• Anti-NASH therapy(s) including S-adenosyl methionine (SAMe), ursodeoxycholic acid (UDCA), and obeticholic acid in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization. For resmetirom; 120 days prior to screening or if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.
• Antidiabetic mediation which may impact NASH histology including thiazolidinediones (pioglitazone, rosiglitazone) in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization.
• Immune modulatory agents including anti-TNF-α therapies (infliximab, adalimumab, etanercept) or anti-integrin therapy (namixilab) in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.
• Any treatment or anticipated initiation (intended use for more than 14 consecutive days) of medications known to have an effect on steatosis (e.g. treatment with corticosteroids [topical and inhaled are allowed]), methotrexate, tamoxifen, valproic acid, amiodarone or tetracycline, estrogens in doses higher than used in oral contraceptives, vitamin A, L-asparaginase, valproate, chloroquine, or antiretroviral drugs in the period from 28 days prior to screening or, if a historical biopsy is used, from 28 days prior to baseline liver biopsy until randomization.
• Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion, or naltrexone alone, or in combination or any other medication, that could promote weight loss, in the opinion of the investigator, in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.
• Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening until randomization.
• Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening until randomization.
• History of liver transplant
• Any weight reduction surgery in the 2 years prior to screening or planned during the study (weight reduction surgery is disallowed during the study), and malabsorptive weight loss surgery (Rouxen-Y or distal gastric bypass) at any time prior to screening.
• Note: Lap banding, if the band has been removed >6 months before baseline liver biopsy, or intragastric balloon, if the balloon has been removed > 6 months before baseline liver biopsy, is allowed.
• Type 1 diabetes mellitus

Where it is running

• Zydus US001 — Maitland, Florida, United States
• Zydus US032 — Birmingham, Alabama, United States
• Zydus US079 — Homewood, Alabama, United States
• Zydus US047 — Phoenix, Arizona, United States
• Zydus US025 — Tucson, Arizona, United States
• Zydus US087 — Tucson, Arizona, United States
• Zydus US029 — Tucson, Arizona, United States
• Zydus US118 — Chula Vista, California, United States
• Zydus US041 — Fresno, California, United States
• Zydus US111 — Gardena, California, United States
• Zydus US013 — Huntington Park, California, United States
• Zydus US065 — La Jolla, California, United States
• Zydus US094 — Lancaster, California, United States
• Zydus US080 — Long Beach, California, United States
• Zydus US090 — Long Beach, California, United States
• Zydus US022 — Los Angeles, California, United States
• Zydus US062 — Los Angeles, California, United States
• Zydus US023 — Murrieta, California, United States
• Zydus US052 — Orange, California, United States
• Zydus US012 — Panorama City, California, United States
• Zydus US039 — Aurora, Colorado, United States
• Zydus US122 — Clearwater, Florida, United States
• Zydus US057 — Fort Myers, Florida, United States
• Zydus US108 — Hallandale, Florida, United States
• Zydus US124 — Maitland, Florida, United States

Full record on ClinicalTrials.gov

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