HDLD-092320 for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Two-arm, Comparative, Multicentric, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of HDLD-092320 in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) - MASLD

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078148

Enrollment

120

Registered

2024-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: E70-E88- Metabolic disorders

Interventions

Intervention1: HDLD-092320: Investigational Product Two tablets twice daily orally after food for 180 days Control Intervention1: Placebo: Placebo Two tablets twice daily orally after food for 180 day

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 adults detected either by imaging techniques or biopsy 3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness with 8 to 12 Kpa

Exclusion criteria

Exclusion criteria: 1. LSM score more than 12kpa Fibrosis stage F3 to F4 confirmed through Fibroscan VCTE. 2. History of histologically confirmed MASLD with advanced fibrosis stage F3 & 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. 2. Change in Liver controlled attenuation parameter [CAP); steatosis] score through VCTE Timepoint: Visit 1: Screening (-14 days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 30± 3 days Visit 4: Day 60± 3 days/ Telephonic visit Visit 5: Day 90± 3 days Visit 6: Day 135±3 days/ Telephonic visit Visit 7: Day 180±3 days/ EOS	—

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Soorya Nayaran H

Himalaya Wellness Company

rajesh.kumawat@himalayawellness.com8067549904

Outcome results

None listed

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