Saroglitazar Magnesium for Cholestatic Liver Disease

Recruiting at 1 trial location

Overseen By Deven Parmar

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Zydus Therapeutics Inc.

Must not be taking: Antibiotics, Antifungals, Antivirals, others

Disqualifiers: Malignancy, Surgery, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Saroglitazar Magnesium for individuals with liver problems due to cholestatic liver disease. The goal is to understand how the body processes this drug and determine its safety. Participants will take a small dose of the medication every other day for 29 days. Ideal candidates for this trial have been diagnosed with moderate liver impairment and cirrhosis from cholestatic liver disease. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial investigator to get a clear answer.

Is there any evidence suggesting that Saroglitazar Magnesium is likely to be safe for humans?

Research has shown that Saroglitazar Magnesium is safe and well-tolerated in individuals with cholestatic cirrhosis, a type of liver disease. Studies found that 1 or 2 mg doses did not significantly affect drug metabolism, even in those with severe kidney problems. Another study demonstrated that Saroglitazar improved liver function in patients with primary biliary cholangitis, another liver disease, and was safe over 16 weeks. These findings suggest that Saroglitazar Magnesium is generally well-tolerated in people with liver issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Saroglitazar Magnesium is unique because it targets cholestatic liver disease with a dual action on both lipid and glucose metabolism, which is different from most current treatments that primarily focus on managing symptoms or slowing disease progression. Unlike the standard bile acid sequestrants, this drug works as a dual PPAR alpha and gamma agonist, potentially addressing the root metabolic disturbances in the liver more effectively. Researchers are excited because this novel mechanism could offer a more comprehensive treatment approach, possibly improving liver function and reducing symptoms more quickly and effectively than existing options.

What evidence suggests that Saroglitazar Magnesium might be an effective treatment for cholestatic liver disease?

Research has shown that Saroglitazar Magnesium may help treat liver conditions. Studies have found it can improve liver enzymes and fat levels in the blood, both crucial for liver health. It was tested in people with primary biliary cholangitis (PBC), a type of liver disease, with positive results. Saroglitazar Magnesium activates certain proteins that control metabolism and reduce inflammation, potentially lessening liver damage and improving liver function in those with liver disease. Participants in this trial will receive Saroglitazar Magnesium 1 mg to further evaluate its effects on cholestatic liver disease. ^{1 2 4 6 7}

Who Is on the Research Team?

Deven Parmar

Principal Investigator

Zydus Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for adults with moderate liver impairment and cirrhosis due to cholestatic liver disease. They must have certain blood test results within specific ranges, no liver cancer, a BMI of 18-48 kg/m2, and the ability to swallow pills. Participants need to consent to follow the trial rules.

Inclusion Criteria

I can swallow and keep down pills.

I agree to participate in the trial and follow its rules.

Alkaline Phosphatase \> upper limit of normal Alanine aminotransferase/Aspartate aminotransferase value ≤ 10 × upper limit of normal Absolute neutrophil count ≥ 750/mm3 Platelets ≥ 25,000/mm3 Hemoglobin ≥ 8 g/dL α-fetoprotein \<50 ng/mL or 50-80 ng/mL with negative imaging study (Ultrasound \[US\], computed tomography scan \[CT\], Magnetic Resonance Imaging \[MRI\]). Imaging study that excluded presence of liver cancer (US in the preceding 6 months and CT or MRI in the preceding 1 year)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast, for the duration of treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Saroglitazar Magnesium

Trial Overview The study tests Saroglitazar Magnesium (1 mg taken every other day) in patients with moderate hepatic impairment from cholestatic liver diseases. It aims to understand how the drug moves through and affects these patients.

How Is the Trial Designed?

Group I: Saroglitazar Magnesium 1 mg Experimental Treatment 1 Intervention

Saroglitazar Magnesium 1 mg tablet orally administered on alternate days in the morning before breakfast without food, for the duration of treatment (29 days)

Who Is Running the Clinical Trial?

Zydus Therapeutics Inc.

Lead Sponsor

Trials

16

Recruited

1,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12395119/

Evaluation of Effectiveness and Tolerability of Saroglitazar in ... Saroglitazar demonstrated significant improvements in glycemic control, lipid profile, and liver enzymes with a favorable safety profile in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07216235

NCT07216235 | Long-Term Study to Evaluate the Safety ... To evaluate the effect of saroglitazar magnesium compared to placebo, based on time to the first occurrence of the defined clinical outcome ...

3. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3450?af=R

Pharmacokinetic, Safety, and Pharmacodynamic Profiles of ... Saroglitazar (1 and 2 mg) was safe and well-tolerated in cholestatic cirrhosis with mild HI and participants with severe RI without major PK changes.

4. empr.com empr.com/news/saroglitizar-demonstrates-efficacy-in-primary-biliary-cholangitis/

Saroglitazar Demonstrates Efficacy in Primary Biliary ... “Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive phase 3 data in patients with PBC and has the potential to bring ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06825559

NCT06825559 | Evaluate PK & Safety of Saroglitazar in ... A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168827821020237

Proof-of-concept study to evaluate the safety and efficacy of ... Saroglitazar resulted in a rapid and sustained improvement in alkaline phosphatase levels in patients with primary biliary cholangitis.

7. journals.lww.com journals.lww.com/ctg/fulltext/2021/04000/a_multicenter,_open_label,_single_arm_study_to.1.aspx

A Multicenter, Open-Label, Single-Arm Study to Evaluate ... Saroglitazar daily for 16 weeks resulted in rapid and sustained improvements in ALP with an acceptable safety profile in patients with PBC.