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

NCT07199933 | Not Yet Recruiting DMC

• 2 other identifiers: 2025NL-167-02SJCX25_0997
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

MAFLD

Keywords

MAFLD; Diacerein

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (1)

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

  From enrollment to the end of treatment at 6 Months

Study Arms (2)

Diacerein 50 mg Capsule

EXPERIMENTAL

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

Drug: Diacerein 50 mg Capsule

Placebo 50 mg Capsule

PLACEBO COMPARATOR

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

Drug: Placebo 50 mg

Interventions

Diacerein 50 mg Capsule DRUG

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

Also known as: serial numbers:0106408804979, Shuangcuruiyin Jiaonang

Diacerein 50 mg Capsule

Placebo 50 mg DRUG

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

Placebo 50 mg Capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• (4) Patients with abnormal vital signs, complete blood count (CBC), renal function, or thyroid function (Alanine Aminotransferase \[ALT\] \>5× upper limit of normal \[ULN\]; Creatinine \[Cr\] \>ULN; Albumin \[ALB\] \<3.5 g/L; TSH \>2× ULN; electrolyte imbalances).
• 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.
• Glycated Hemoglobin A1c (HbA1c) \>7% (in patients without prior history of diabetes).
• Patients with inflammatory bowel disease, intestinal obstruction or pseudo-obstruction, chronic diarrhea, or unexplained abdominal pain.
• History of bariatric surgery within the past 2 years.
• History of allergy to diacerein or anthraquinone derivatives.
• Use of diacerein within the past 3 months.
• Pregnant or lactating women, or those planning pregnancy within the next 6 months.
• Participation in another clinical trial involving investigational drugs or devices.
• Contraindications to conventional MRI (e.g., metal implants).
• Inability to complete the study or comply with its requirements, as determined by the investigator.
• Weight gain or loss \>5% within 6 months prior to baseline, or \>10% within 12 months prior to screening.

Sponsors & Collaborators

• Hongyan Wu: lead

MeSH Terms

Interventions

diacerein

Study Officials

• Yingjie Chen

  Affiliated Hospital of Nanjing University of Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Wenbin Shang

CONTACT

025-85811146; wbshang@njucm.edu.cn

Hongyan Wu

CONTACT

15850562780; whyan618@njucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical graduate student

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share