Clinical study to evaluate efficacy and safety of Ursodeoxycholic acid tablet in patients with non-alcoholic fatty liver disease (NAFLD) with transaminitis.

A randomized, single blind, placebo-controlled, multicentre, Phase III study to evaluate the efficacy and safety of Ursodeoxycholic acid (150/300/450/600 mg) in patients with non-alcoholic fatty liver disease (NAFLD) with transaminitis. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084464

Enrollment

150

Registered

2025-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Ursodeoxycholic Acid (150/300/450/600 mg): 1 tablet twice a day for 6 months Control Intervention1: Placebo (150/300/450/600 mg): 1 tablet twice a day for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: a. Adult male and non-pregnant, non-lactating females between 18 60 years of age (inclusive), at study entry. b. Willing to provide informed consent for study participation. c. Confirmed Diagnosis of NAFLD established by imaging (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]). d. Subjects with alanine aminotransferase levels 1.5 times the upper limit of normal. e. Subject s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations.

Exclusion criteria

Exclusion criteria: o Subjects with a medical history of alcoholic liver disease. Note: In Indian patients, significant alcohol consumption is defined as intake of 20 gm of alcohol per day for both males and females (INASL 2023 guidelines). o Use of any drugs, in the investigator s opinion, having a potential effect on NAFLD with transaminitis patients within 1 month of screening. o Subjects with an active disease or known medical history of positive viral markers (hepatitis B surface antigen [HBsAg] and hepatitis C virus [anti-HCV] antibodies) or an ultrasound indicative of viral hepatitis. o Subjects with a known medical history of chronic liver disease other than NAFLD. o Subjects with a known medical history of ischemic heart disease. o Contraindications to ursodeoxycholic acid. o Medical history of severe illness or any other conditions that would make the subject, in the opinion of the investigator, ineligible for the study.

Design outcomes

Primary

Measure	Time frame
Percentage reduction of alanine transaminase (ALT) levels from baseline to 4 weeks after treatment with ursodeoxycholic acid (UDCA) plus standard of care (SOC) versus Placebo plus SOC in patients who have Non-Alcoholic Fatty Liver Disease (NAFLD) with transaminitis.Timepoint: Percentage reduction of alanine transaminase (ALT) levels from baseline to 4 weeks after treatment with ursodeoxycholic acid (UDCA) plus standard of care (SOC) versus Placebo plus SOC in patients who have Non-Alcoholic Fatty Liver Disease (NAFLD) with transaminitis.	—

Measure

Time frame

Percentage reduction of alanine transaminase (ALT) levels from baseline to 4 weeks after treatment with ursodeoxycholic acid (UDCA) plus standard of care (SOC) versus Placebo plus SOC in patients who have Non-Alcoholic Fatty Liver Disease (NAFLD) with transaminitis.Timepoint: Percentage reduction of alanine transaminase (ALT) levels from baseline to 4 weeks after treatment with ursodeoxycholic acid (UDCA) plus standard of care (SOC) versus Placebo plus SOC in patients who have Non-Alcoholic Fatty Liver Disease (NAFLD) with transaminitis.

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Secondary

Measure	Time frame
Percentage reduction of ALT levels from baseline after 3 months and 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis. Percentage reduction of aspartate transaminase (AST) levels after 1, 3 and 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis. percentage reduction of alkaline phosphatase (ALP) levels after 1, 3 and 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis. Proportion of patients showing ALT normalization after 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients of NAFLD with transaminitis. Mean reduction of Controlled Attenuation Parameter (CAP) score after 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis.Timepoint: 1, 3 and 6 months	—

Measure

Time frame

Percentage reduction of ALT levels from baseline after 3 months and 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis. Percentage reduction of aspartate transaminase (AST) levels after 1, 3 and 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis. percentage reduction of alkaline phosphatase (ALP) levels after 1, 3 and 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis. Proportion of patients showing ALT normalization after 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients of NAFLD with transaminitis. Mean reduction of Controlled Attenuation Parameter (CAP) score after 6 months of treatment with UDCA plus SOC versus Placebo plus SOC in patients who have NAFLD with transaminitis.Timepoint: 1, 3 and 6 months

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Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott India Limited

shivani.acharya@abbott.com912250460456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026