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Dihydroartemisinin for MAFLD

NCT07679542 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-01

No results posted yet for this study

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).

Conditions

  • MAFLD

Interventions

DRUG

Dihydroartemisinin

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2026-06-30
Completion
2026-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679542 on ClinicalTrials.gov