Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

NCT05045482

Hepatic Impairment Cirrhosis Cholestatic Liver Disease

RECRUITING PHASE1

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

NCT04469920

Hepatic Impairment

COMPLETED PHASE1

Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

NCT03061721

Non-Alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

COMPLETED PHASE2

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

NCT03863574

Non Alcoholic Steatohepatitis

COMPLETED PHASE2

Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)

NCT03639623

Liver Transplant; Complications NAFLD

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholestatic Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saroglitazar Magnesium 1 mg

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

Group Type EXPERIMENTAL

Saroglitazar Magnesium 1 mg

Intervention Type DRUG

Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saroglitazar Magnesium 1 mg

Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Not any

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
2. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
3. Ability to swallow and retain oral medication.
4. Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.
5. Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening:

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)
6. Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria

1. Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
2. History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).
3. History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
4. The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
5. Any major surgery within 3 months of screening.
6. Donation of blood or blood products within 3 months of screening.
7. Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
8. Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
9. Estimated glomerular filtration rate (\<45 mL/min/1.73 m2 by CKD-EPI 2021 formula at screening.
10. Any individual with poor peripheral venous access.
11. Receipt of blood products within 1 month of check in.
12. Human immunodeficiency virus type 1 antibody positive at screening.
13. Other known causes of liver disease, such as non-alcoholic steatohepatitis , alcoholic steatohepatitis, autoimmune hepatitis, or acute or chronic viral hepatitis (including Hepatitis B and C) as determined by the investigator and subject's medical records.
14. Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the subject's medical history and deemed clinically significant by the investigator.
15. Subjects having - History of gastrointestinal bleeding within 1 month of screening. Current functioning organ transplant. Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.
16. Pregnancy-related exclusions, including:

Pregnant/lactating female (including positive pregnancy test at screening) Pregnancy should be avoided by male and female subjects either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No