Saroglitazar Magnesium for Primary Biliary Cirrhosis
Recruiting in Palo Alto (17 mi)
+45 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Zydus Therapeutics Inc.
Must not be taking: Thiazolidinediones, Fibrates, PPAR agonists, others
Disqualifiers: Liver diseases, Cirrhosis, Cardiovascular, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as Thiazolidinediones, Fibrates, and other specific drugs, at least 12 weeks before screening. If you're on these medications, you may need to stop them before joining the trial.
Eligibility Criteria
This trial is for individuals who have completed the SARO.21.001 study on primary biliary cholangitis and agreed to follow the protocol. They must not be heavy drinkers, have a MELD score under 15, or suffer from other liver diseases, unstable heart disease, uncontrolled thyroid issues, muscle diseases, or severe illnesses.Inclusion Criteria
Must provide written informed consent and agree to comply with the trial protocol
Participated and completed SARO.21.001, the double-blind treatment phase study
Exclusion Criteria
I have been drinking no more than the daily limit for my gender for the past 3 months.
Participants with MELD 3.0 score of 15 or greater
History or presence of other concomitant liver diseases at screening: Chronic hepatitis B or C virus (HBV, HCV) infection, Primary sclerosing cholangitis (PSC), Alcoholic liver disease, Autoimmune hepatitis (AIH)-PBC overlap syndrome, Hemochromatosis, Non-alcoholic steatohepatitis (NASH) on historical biopsy, Cirrhosis with complications, Use of Thiazolidinediones or Fibrates, Use of Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids, History of bowel surgery, Unstable cardiovascular disease, An uncontrolled thyroid disorder, History of myopathies or evidence of active muscle disease, Abnormal laboratory values, Participation in another interventional clinical study, History of malignancy, Known allergy, sensitivity or intolerance to the study medication or formulation ingredients, Pregnancy-related exclusions, History or other evidence of severe illness or any other conditions that would make the participant unsuitable for the study, Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Saroglitazar Magnesium 1 mg tablet orally once daily for 24 months
24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
Open-label extension
Continuation of treatment to evaluate long-term safety and efficacy
24 months
Participant Groups
The trial tests Saroglitazar Magnesium at a dose of 1 mg in patients with primary biliary cholangitis. It's an open-label extension which means everyone knows they're getting the actual drug and there's no placebo involved.
1Treatment groups
Experimental Treatment
Group I: Saroglitazar Magnesium 1 mgExperimental Treatment1 Intervention
Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).
Saroglitazar Magnesium is already approved in India for the following indications:
🇮🇳 Approved in India as Lipaglyn for:
- Type 2 diabetes mellitus
- Dyslipidemia
- Non-alcoholic fatty liver disease (NAFLD)
- Non-alcoholic steatohepatitis (NASH)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Zydus US020Marietta, GA
Zydus US030Saint Louis, MO
Zydus US022Aurora, CO
Zydus US001Indianapolis, IN
More Trial Locations
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Who Is Running the Clinical Trial?
Zydus Therapeutics Inc.Lead Sponsor
References
A Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Saroglitazar in Patients With Primary Biliary Cholangitis. [2023]Patients with primary biliary cholangitis (PBC) without biochemical response to ursodeoxycholic acid (UDCA) are at increased risk of liver-related mortality. Saroglitazar is a novel peroxisome proliferator-activated receptor (PPAR) agonist with dual PPAR agonistic properties (α/γ). There is a strong mechanistic rationale for studying saroglitazar in PBC because PPARα is a molecular target of fibrates that showed improvements in liver tests in patients with PBC.
Proof-of-concept study to evaluate the safety and efficacy of saroglitazar in patients with primary biliary cholangitis. [2022]Saroglitazar is a novel peroxisome proliferator-activated receptor (PPAR) agonist with dual agonistic properties (α/γ). Due to a strong mechanistic rationale, we aimed to test the safety and efficacy of saroglitazar in patients with primary biliary cholangitis (PBC) who were either ursodeoxycholic acid (UDCA) resistant or intolerant.
Pharmacokinetics and Safety Evaluation of Single-Dose Saroglitazar Magnesium in Subjects with Hepatic Impairment. [2023]Saroglitazar magnesium, a dual peroxisome proliferator-activated receptor agonist, is under evaluation for treating various liver conditions. While the pharmacokinetics (PK) of saroglitazar have been extensively studied in diverse preclinical models and healthy subjects, a comprehensive assessment of its PK behavior under conditions of hepatic impairment is lacking. In this Phase 1, open-label, parallel-group study, the PK of a single dose of 4-mg saroglitazar magnesium was investigated in subjects having varying degrees of hepatic impairment with and without portal hypertension compared with appropriately matched individuals having normal hepatic function. Treatment-emergent adverse events for safety were also evaluated. Thirty-two subjects were enrolled in the hepatic-impaired groups and 23 subjects in the normal hepatic function group. Mild and moderate hepatic impairment did not significantly affect the PK of saroglitazar, compared with normal hepatic function. Although severe hepatic impairment did not alter maximum observed plasma concentration and half-life; saroglitazar exposure (area under the plasma concentration-time curve from time 0 to infinity) increased 3-fold, while the clearance was 61% lower compared to the subjects with normal hepatic function. This may require close monitoring or dose adjustments in individuals with severe hepatic impairment. A single oral dose of saroglitazar magnesium 4 mg was found to be safe and well tolerated in subjects with varying degrees of hepatic function.
Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]This systematic review and meta-analysis was conducted to evaluate the efficacy and safety of 4 mg saroglitazar treatment in patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH).
Saroglitazar for Nonalcoholic Fatty Liver Disease: A Single Centre Experience in 91 Patients. [2023]Saroglitazar is a novel, dual peroxisome proliferator-activated receptors-α/γ agonist and is being investigated for the treatment of nonalcoholic fatty liver disease (NAFLD).