Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease

ConditionMAFLD

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorHongyan Wu

About this trial

Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic progressive liver disease in China, posing a significant risk for hepatic decompensation, cardiovascular disease (CVD), chronic kidney disease (CKD), and various malignancies. It severely impacts patient quality of life and life expectancy, creating a substantial socioeconomic burden. Currently, no safe and effective drug exists to reverse MAFLD.

Rhubarb (Dà Huáng), a classic Traditional Chinese Medicine (TCM) herb for liver disorders, has a cold nature, bitter taste, and targets the liver, spleen, stomach, large intestine, and pericardium meridians. Its primary active component, Rhein, demonstrates therapeutic potential by targeting key MAFLD pathological processes-insulin resistance, hepatic steatosis, inflammation, and fibrosis. Supporting this, a previous randomized, double-blind, placebo-controlled trial by our group on diacerein (a Rhein derivative) for simple obesity showed that it not only reduced body weight but also improved liver function, Controlled Attenuation Parameter (CAP), and Liver Stiffness Measurement (LSM).

Therefore, this study will investigate diacerein-a marketed drug metabolized to Rhein in vivo-for MAFLD treatment using a randomized, double-blind, placebo-controlled design. The aim is to generate clinical evidence for diacerein and other Rhein derivatives within an integrative medicine framework, providing an evidence-based rationale for expanding the application of rhubarb in MAFLD management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand this study and voluntarily sign the informed consent form; willing to comply with and capable of completing all trial procedures.

Meet the diagnostic criteria for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Age ≥18 and ≤60 years, regardless of gender.

Disqualifiers

Patients with other diseases that may secondarily cause fatty liver disease, including hepatitis B or C virus infection, α-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or HIV infection.

Alcohol consumption ≥140 g/week for females or ≥210 g/week for males.

Patients with current or history of cirrhosis or any prior event of hepatic decompensation (i.e., ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, esophageal varices, and/or hepatorenal syndrome).

Patients with severe cardiovascular or cerebrovascular diseases (including uncontrolled hypertension, defined as systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg), renal diseases, hematopoietic system diseases, psychiatric disorders, autoimmune diseases, or active cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

Diacerein 50 mg Capsule
Drug
Drug:Diacerein 50 mg Capsule. Weeks 1-4: 50 mg/day; Weeks 5-24: 100 mg/day.
Placebo 50 mg
Drug
Drug:Placebo 50 mg Capsule. Weeks 1-4: 50 mg/day; Weeks 5-24: 100 mg/day.

Treatment groups

74 Participants

are divided into 2 treatment groups

Group A: Diacerein 50 mg CapsuleExperimental treatment 1 intervention

Group B: Placebo 50 mg CapsulePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Absolute change or relative change in Intrahepatic Lipid Content, by Magnetic resonance imaging-proton density fat fraction(MRI-PDFF).

Absolute percentage change in intrahepatic lipid content, quantified by MRI-PDFF

Time frame

From enrollment to the end of treatment at 6 months

Secondary outcomes

CAP（Controlled Attenuation Parameter）、LSM（Liver Stiffness Measurement）、ALT（Alanine Aminotransferase）、AST（Aspartate Aminotransferase）、Agile Score、FAST Score（FibroScan-AST Score）

CAP(dB/m) and LSM(kPa) values measured by Fibroscan; ALT（U/L）and AST（U/L）levels from liver function tests; the Agile score calculates based on LSM, CAP, ALT, AST, platelet count, age, sex, and diabetes status; the FAST score derives from LSM, CAP, and AST measurements. Agile Score (range 0-1): A score exceeding the threshold of 0.67 warrants high clinical suspicion for advanced hepatic fibrosis. FAST Score (range 0-1): FAST Score \< 0.35: Indicates a very low probability of the patient having both non-alcoholic steatohepatitis (NASH) and significant fibrosis (NASH + ≥F2). 0.35 ≤ FAST Score ≤ 0.67: Suggests that a liver biopsy may be necessary to confirm the diagnosis. FAST Score \> 0.67: Indicates a high likelihood that the patient belongs to a high-risk group with NASH and significant fibrosis.

Time frame

From enrollment to the end of treatment at 6 Months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hongyan Wu

Lead sponsor

Nanjing University of Traditional Chinese Medicine

Sponsor institution

Source ClinicalTrials.gov

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