Dihydroartemisinin for MAFLD in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label study where all eligible participants receive dihydroartemisinin and serve as their own controls by comparing measurements before and after treatment. Approximately 30 adults aged 18 to 45 with MAFLD will be enrolled and will receive standardized lifestyle counseling at baseline to minimize confounding. The trial will assess changes in liver fat and evaluate the safety and tolerability of dihydroartemisinin in this population. Enrollment is restricted to those meeting imaging, biopsy, or CAP-based criteria for hepatic steatosis and metabolic dysfunction. The study design does not include a control arm and focuses on early feasibility and safety signals, guiding future investigations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Aged 18-45 years (inclusive), any gender.

Meets the diagnostic criteria for Metabolic Associated Fatty Liver Disease (MAFLD), requiring both of the following:

Evidence of hepatic steatosis (at least one of the following):

Imaging: Ultrasound, CT, or MRI-PDFF showing liver fat content ≥5%.

Liver biopsy: Histologically confirmed steatosis ≥5% (within 6 months prior to enrollment).

FibroScan: Controlled Attenuation Parameter (CAP) ≥248 dB/m.

Evidence of metabolic dysfunction (at least one of the following):

Overweight/Obesity: BMI ≥24 kg/m² or waist circumference ≥90 cm (male) / ≥85 cm (female).

Elevated blood pressure/Hypertension: Blood pressure ≥130/85 mmHg, or on antihypertensive medication.

Pre-diabetes or Type 2 Diabetes: Fasting blood glucose ≥6.1 mmol/L, or 2-hour post-load glucose ≥7.8 mmol/L, or HbA1c ≥5.7%, or history of T2DM, or HOMA-IR ≥2.5.

Elevated blood triglycerides: Fasting serum TG ≥1.70 mmol/L, or on lipid-lowering medication.

Reduced HDL-cholesterol: Serum HDL ≤1.0 mmol/L (male) / ≤1.3 mmol/L (female), or on lipid-lowering medication.

Participants on glucose-, blood pressure-, or lipid-lowering medications must have been on a stable dose for at least 3 months prior to screening.

All participants must have stable body weight (defined as weight loss or gain not exceeding 5% within 3 months prior to screening and from screening to enrollment).

Voluntary participation, willingness to cooperate with follow-up, and signed informed consent.

Exclusion Criteria:

Liver function impairment (defined as any one of ALT, AST, GGT, ALP exceeding 2 times the upper limit of normal (ULN) and/or bilirubin exceeding 1.5 times ULN).

Long-term use (exceeding 2 weeks) of drugs known to cause hepatic steatosis or fibrosis (e.g., glucocorticoids, valproate, methotrexate, tamoxifen, amiodarone, oral vitamin E) within the past year.

Excessive alcohol consumption: weekly ethanol intake ≥210 g (male) or ≥140 g (female).

Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCV-Ab).

Specific liver diseases that can cause fatty liver (e.g., autoimmune hepatitis, Wilson's disease) or other specific conditions (e.g., total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome).

History of leukopenia or agranulocytosis.

History of bariatric surgery within the past 2 years.

Pregnant, planning pregnancy, or lactating women.

History of malignancy, cardiovascular disease, chronic kidney disease, decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome), or liver transplantation.

Use of any category of antibiotics within 2 weeks prior to enrollment.

Considered by the clinical investigator to be unsuitable for participation in the study.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu 210029
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xuehao Wang, Doctor
• Email: Wangxh@njmu.edu.cn
• Phone: 86-025-68303211

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.