A clinical study to evaulate the efficacy and safety of Liv.52 DS tablets in Fatty Liver Disease.

Phase 3

• Conditions: Health Condition 1: E70-E88- Metabolic disorders

• Registration Number: CTRI/2022/03/041481
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adult male and female subjects aged between =18 and =65 years.

Subjects who are clinically diagnosed with Metabolic dysfunction-associated Fatty Liver Disease (MAFLD) defined as Hepatic Steatosis in adults (detected either by imaging techniques, blood biomarkers/scores or by liver histology) in addition to one of the following criterias, namely,

A. Overweight or obesity (defined as BMI =25 kg/m2 in Caucasians or BMI =23 kg/m2 in Asians)

B. Type 2 Diabetes Mellitus C. Lean or normal weight (defined as BMI <25 kg/m2 in Caucasians or BMI <23 kg/m2 in Asians) with the presence of at least 2 metabolic risk abnormalities from the listed below,

Waist circumference =102/88 cm in Caucasian men and women or =90/80 cm in Asian men and women

Blood pressure =130/85 mmHg or specific drug treatment

Plasma triglycerides =150 mg/dl (=1.70 mmol/L) or specific drug treatment Plasma HDL-cholesterol <40 mg/dl ( <1.0 mmol/L) for men and <50 mg/dl ( <1.3 mmol/L) for Women or specific drug treatment o Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl [5.6 to 6.9 mmol/L], or 2-hour post-load Glucose levels 140 to 199 mg/dl [7.8 to 11.0 mmol] or HbA1c 5.7% to 6.4% [39 to 47 mmol/mol])

Homeostasis model assessment of insulin resistance score =2.5 o Plasma high-sensitivity C-reactive protein level >2 mg/L 3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness as defined by,

Liver Stiffness Measurement score of =6.2 to = 9.8 Kpa from Vibration Controlled Transient Elastography (VCTE)

Any grade of steatosis (S1-S3) from Continuous Attenuation Parameter (CAP)

AST value of >1.5 times the Upper Limit of the Normal.

ALT = 1.5 times the Upper Limit of the Normal. 5. Female must be either of non-child bearing potential (surgically sterilized at least 6 months prior to screening or postmenopausal) or using one or more methods of contraception and non-lactating.

Subjects willing to sign informed consent.

Exclusion Criteria

FIBROSCAN confirmed LSM score > 9.8kpa (F3-F4) confirmed through VCTE.

History of histologic confirmed MAFLD with advanced fibrosis (stage 3, 4).

History of Cirrhosis or its complications(like HCC, Portal HTN, Liver failure).

Complications may involve:

Patients listed for living-related or orthotopic liver transplantation

Patients with a history of hepatocellular carcinoma (HCC) or history of HCC treatment.

Evidence of portal hypertension (e.g., low Platelet counts,

esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly)

(Radiologic imaging consistent with cirrhosis or portal hypertension would also be excluded)

Other cause of Steatosis (Hep-C, Wilson Disease, Medications, Severe malnutrition).

Subjects diagnosed as Alcoholic Liver Disease (ALD) ? on the basis of all of the following criteria:

Patient with a history of alcohol abuse based on AUDIT questionnaire (A total sum of >8 for men and >4 for women)

Active alcohol use until 4 weeks prior to screening

Patients with elevated liver function test of ALT and AST >1.5 times of upper limit of normal.

Ultrasound evidence Alcoholic fatty liver and / or Alcoholic Hepatitis Alcohol Liver disease.

Maddrey Discriminant function (DF) less than 32.

History of other co-existing Chronic Liver Diseases (such as Chronic Viral hepatitis, Hemochromatosis, Autoimmune Liver Disease, DILI, Alpha-1 Anti-trypsin Deficiency etc).

Subjects with history of myopathies or evidence of active muscle diseases.

Evidence of poorly-controlled diabetes [glycosylated haemoglobin (HbA1c) > 9%].

Subject with the history of type I diabetes mellitus.

Other Laboratory Screening Results:

• Total white blood cells (WBC) <3,000 cells/mm3

• Absolute neutrophil count (ANC) <1,500 cells/mm3

• Platelet count <1,00,000/mm3

• Prothrombin time > 1.2 INR

• Creatine kinase above the upper limit of normal (ULN) except when in relation with intense exercise.

• Serum creatinine >2 mg/dL or creatinine clearance <60 ml/min (based on MDRD)

Subject on fibrates (Other drugs for dyslipidaemia will be allowed provided dose is stable in last 6 months).

Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or MAFLD for more than12 consecutive weeks in the 1 year prior to start of the study; (these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens, valproate/valproic acid, chloroquine, anti-HIV drugs etc.).

Subjects with uncontrolled clinically significant serious conditions like severe anemia, severe cardiovascular disease, respiratory, hepatic, neurological, psychiatric, or malignancy/bleeding disorder or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this

study, or will make implementation of the protocol or interpretation of the study results difficult.

History of bariatric surgery within 1 year or planned Bariatric surgery.

Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines.

Known allergy, sensitivity or intolerance to the study drugs or their

Study & Design

• Study Type: Interventional
• Study Design: Not specified