Could a malaria drug melt liver fat? new trial investigates
NCT ID NCT07679542
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether dihydroartemisinin, a drug used for malaria, can safely reduce liver fat in adults with Metabolic Associated Fatty Liver Disease (MAFLD). About 30 participants aged 18 to 45 will take the drug three times daily for 12 weeks. The main goal is to measure changes in liver fat using MRI scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dihydroartemisinin
- What this could lead to
- If successful, this could point toward a new treatment option for metabolic fatty liver disease using a well-known malaria drug.
- What could go wrong
- This is a small, early-phase proof-of-concept study with no control group, so results may not be conclusive. The drug's effectiveness for liver fat reduction is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu 210029
RECRUITINGNanjing, Jiangsu, China
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