A randomized, double blind, placebo controlled , multicenter, 12 weeks study to assess safety ,tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis

A randomized, double-blind, placebo controlled, 3- part, adaptive design, multicenter study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with non-alcoholic steatohepatitis (NASH) - NASH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014509

Enrollment

250

Registered

2018-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: null- Non-alcoholic Steatohepatitis NASH

Interventions

Intervention1: Arm A LJN452 dose 1 : Once daily (morning fasting) treatment with 10 µg LJN452 for 12 weeks Intervention2: Arm B: Once daily (morning fasting) treatment with 10 µg LJN452 for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1 male/female patients, 18 years or older 2 written informed consent 3 presence of NASH by histological evidence (liver biopsy) and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM) 4 Liver fat equal to or higher than 10% by MRI

Exclusion criteria

Exclusion criteria: 1 previous exposure to OCA 2 patients taking prohibited medications 3 pregnant or nursing (lactating) women 4 current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening 5 uncontrolled diabetes mellitus 6 presence of cirrhosis 7 hepatic decompensation or severe liver impairment 8 previous diagnosis of other forms of chronic liver disease 9 patients with contraindications to MRI imaging

Design outcomes

Primary

Measure	Time frame
1 Adverse event profile of different doses of LJN452 in patients with NASH 2 Change in Transaminase levelsTimepoint: 12 weeks	—

Secondary

Measure	Time frame
1 Change from baseline in percentage of fat in the liver assessed using MRITimepoint: 12 weeks;2 Change from baseline in weightTimepoint: 12 weeks;Change from baseline in biomarker FGF19Timepoint: 12 weeks;Change from baseline on on markers of liver fibrosisTimepoint: 12 weeks;Change from baseline on gamma-glutamyl transferase (GGT)Timepoint: 12 weeks;Change from baseline on fasting lipid profileTimepoint: 12 weeks;Determine Ctrough of LJN452Timepoint: 12 weeks;Itch based on a visual analog scale (VAS) rating scaleTimepoint: 12 weeks;Change from baseline in BMITimepoint: 12 weeks;Change from baseline in waist-to-hip (WTH) ratioTimepoint: 12 weeks;Change from baseline in biomarker C4Timepoint: 12 weeks;Determine C2h of LJN452Timepoint: 12 weeks	—

Measure

Time frame

1 Change from baseline in percentage of fat in the liver assessed using MRITimepoint: 12 weeks;2 Change from baseline in weightTimepoint: 12 weeks;Change from baseline in biomarker FGF19Timepoint: 12 weeks;Change from baseline on on markers of liver fibrosisTimepoint: 12 weeks;Change from baseline on gamma-glutamyl transferase (GGT)Timepoint: 12 weeks;Change from baseline on fasting lipid profileTimepoint: 12 weeks;Determine Ctrough of LJN452Timepoint: 12 weeks;Itch based on a visual analog scale (VAS) rating scaleTimepoint: 12 weeks;Change from baseline in BMITimepoint: 12 weeks;Change from baseline in waist-to-hip (WTH) ratioTimepoint: 12 weeks;Change from baseline in biomarker C4Timepoint: 12 weeks;Determine C2h of LJN452Timepoint: 12 weeks

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Countries

Australia, Austria, Belgium, Canada, France, Germany, India, Italy, Netherlands, Slovakia, Spain, Switzerland, Taiwan, United States of America

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com02224958545

Outcome results

None listed

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