RecruitingPhase 1Phase 2NCT07679542

Dihydroartemisinin for MAFLD

A Single-Arm, Proof-of-Concept Study of Dihydroartemisinin in Adults With Metabolic Associated Fatty Liver Disease


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

30 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dihydroartemisinin for people with mafld. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDihydroartemisinin

Oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks


Locations(1)

The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu 210029

Nanjing, Jiangsu, China

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NCT07679542


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