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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu 210029
Nanjing, Jiangsu, China
RECRUITINGChange in Liver Fat Content Measured by MRI Proton Density Fat Fraction (MRI-PDFF)
Absolute change in liver fat percentage (%) from baseline to the end of treatment, as assessed by MRI-PDFF
Time frame: Baseline (Week 0) to End of Treatment (Week 12)
Change in Controlled Attenuation Parameter (CAP)
Absolute change in Controlled Attenuation Parameter (CAP, measured in dB/m) from baseline, as assessed by FibroScan.
Time frame: Baseline (Week 0), End of Treatment (Week 12), End of Follow-up (Week 24)
Change in Liver Fat Content Measured by Ultrasound-derived Fat Fraction (UDFF)
Absolute change in liver fat percentage (%) from baseline to the end of 12-week treatment, as quantitatively assessed by Ultrasound-derived Fat Fraction (UDFF).
Time frame: Baseline (Week 0) to End of Treatment (Week 12)
Change in Body Weight
Absolute change in body weight (kg) from baseline.
Time frame: Baseline (Week 0), End of Treatment (Week 12), End of Follow-up (Week 24)
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