Clinical study to evaluate HLTX-072522 for the safety and improvement in liver parameters in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Two-arm, Comparative, Multicentric Clinical Study to Evaluate the Safety and Efficacy of HLTX-072522 in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). - MASLD

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100484

Enrollment

120

Registered

2026-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: E713- Disorders of fatty-acid metabolism

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult male and female participants aged between 18 and 60 years. 2. Diagnosed with Metabolic dysfunction-associated steatotic liver disease defined as hepatic steatosis in adultsdetected either by imaging techniques or biopsy 3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness with 8 to 10 Kpa

Exclusion criteria

Exclusion criteria: 1. LSM score more than 10kpa Fibrosis stage F3 to F4 confirmed through Fibroscan VCTE. 2. History of histologically confirmed MASLD with advanced fibrosis stage F4. 3. History of Cirrhosis or its complications Elevated liver parameters ALT, AST, ALP more than 5 times ULN and Total Bilirubin more 3 times ULN

Design outcomes

Primary

Measure	Time frame
1. Change in Liver Stiffness Measurement [(LSM); fibrosis] score through VCTE from baseline to EOS. 2. Change in Liver controlled attenuation parameter [CAP); steatosis] score through VCTE from baseline to EOS.Timepoint: Visit 1: Screening (-14 days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 30Â± 3 days Visit 4: Day 60Â± 3 days/ Telephonic visit Visit 5: Day 90Â± 3 days Visit 6: Day 135Â±3 days/ Telephonic visit Visit 7: Day 180Â±3 days/ EOS	—

Measure

Time frame

1. Change in Liver Stiffness Measurement [(LSM); fibrosis] score through VCTE from baseline to EOS. 2. Change in Liver controlled attenuation parameter [CAP); steatosis] score through VCTE from baseline to EOS.Timepoint: Visit 1: Screening (-14 days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 30Â± 3 days Visit 4: Day 60Â± 3 days/ Telephonic visit Visit 5: Day 90Â± 3 days Visit 6: Day 135Â±3 days/ Telephonic visit Visit 7: Day 180Â±3 days/ EOS

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Secondary

Measure	Time frame
1. Change in BMI and/or Waist circumference at baseline, visit 3, visit 5 and EOS. 2. Change in Lipid Profile (HDL, Triglycerides) from baseline to EOS. 3. Change in HbA1C at baseline, visit 5, and EOS. 4. Change in Fasting serum glucose level at baseline, visit 3, visit 5 and EOS. 5. Change in Systolic BP and Diastolic BP from baseline to EOS. 6. Change in Liver function test (AST, ALT, ALP, Total bilirubin) at baseline, visit 3, visit 5 and EOS. 7.Incidence of adverse events during the study period.Timepoint: Visit 1: Screening (-14 days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 30Â± 3 days Visit 4: Day 60Â± 3 days/ Telephonic visit Visit 5: Day 90Â± 3 days Visit 6: Day 135Â±3 days/ Telephonic visit Visit 7: Day 180Â±3 days/ EOS;Improvement in quality of life from baseline to EOS using questionnaire.Timepoint: Visit 2:Baseline/Day 1 Visit 7:Day 180Â±3 days/ EOS	—

Measure

Time frame

1. Change in BMI and/or Waist circumference at baseline, visit 3, visit 5 and EOS. 2. Change in Lipid Profile (HDL, Triglycerides) from baseline to EOS. 3. Change in HbA1C at baseline, visit 5, and EOS. 4. Change in Fasting serum glucose level at baseline, visit 3, visit 5 and EOS. 5. Change in Systolic BP and Diastolic BP from baseline to EOS. 6. Change in Liver function test (AST, ALT, ALP, Total bilirubin) at baseline, visit 3, visit 5 and EOS. 7.Incidence of adverse events during the study period.Timepoint: Visit 1: Screening (-14 days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 30Â± 3 days Visit 4: Day 60Â± 3 days/ Telephonic visit Visit 5: Day 90Â± 3 days Visit 6: Day 135Â±3 days/ Telephonic visit Visit 7: Day 180Â±3 days/ EOS;Improvement in quality of life from baseline to EOS using questionnaire.Timepoint: Visit 2:Baseline/Day 1 Visit 7:Day 180Â±3 days/ EOS

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Countries

India

Contacts

Public ContactDr Soorya Narayan H

Himalaya Wellness Company

rajesh.kumawat@himalayawellness.com08067549904

Outcome results