RecruitingPhase 1/2

Dihydroartemisinin for MAFLD

China30 participantsStarted 2026-03-30

Plain-language summary

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. Study Design: This is a single-center, open-label, single-arm study. All qualified participants will receive the investigational treatment, with each individual serving as their own baseline control to measure pre- and post-treatment changes. To minimize lifestyle-related confounding factors, all participants will receive standardized dietary and physical activity counseling at baseline and will be instructed to strictly maintain their established lifestyle routines throughout the study period. Participants: The study plans to enroll approximately 30 adult patients (ages 18 to 45 years) formally diagnosed with MAFLD. MAFLD is defined by the presence of excessive hepatic fat accumulation concurrent with specific metabolic dysfunctions, such as overweight/obesity, hypertension, elevated blood sugar, or dyslipidemia. Intervention: Participants will be administered oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for a continuous duration of 12 weeks. Upon completion of the intervention, participants will enter a 12-week observational follow-up period to monitor the durability of the treatment effects and long-term safety. Main Things We Will Measure (Outcomes): Primary Outcome: Absolute change in liver fat content from baseline to the end of the 12-week treatment, quantitatively assessed by the gold-standard MRI Proton Density Fat Fraction (MRI-PDFF). Secondary Outcomes: Changes in supplementary non-invasive liver fat assessments (including Ultrasound-derived Fat Fraction \[UDFF\] and FibroScan Controlled Attenuation Parameter \[CAP\]), as well as changes in body weight, blood pressure, heart rate, and routine laboratory safety panels (e.g., comprehensive liver and kidney function tests).

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 informe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Liver Fat Content Measured by MRI Proton Density Fat Fraction (MRI-PDFF)

Timeframe: Baseline (Week 0) to End of Treatment (Week 12)

Trial details

NCT IDNCT07679542

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Xuehao Wang, Doctor

86-025-68303211 Wangxh@njmu.edu.cn

View on ClinicalTrials.gov More MAFLD trials