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New treatment option for MAFLD
Official title Dihydroartemisinin for MAFLD
ClinicalTrials.gov ID: NCT07679542
What this study is testing
What is Dihydroartemisinin?
Dihydroartemisinin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mafld.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Brief Summary Purpose: This is a proof-of-concept clinical trial to evaluate whether Dihydroartemisinin (DHA), a medication commonly used to treat malaria, can effectively reduce liver fat in adults with Metabolic Associated Fatty Liver Disease (MAFLD). The study will also rigorously assess the safety and tolerability of DHA in this specific patient population.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- 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).
You likely can't join if
- 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...
- Long-term use (exceeding 2 weeks) of drugs known to cause hepatic steatosis or fibrosis (e.g., glucocorticoids, valproate, methotrexate, tamoxifen...
- 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...
- History of leukopenia or agranulocytosis.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.