MAFLDPhase 1/2NCT07679542
Dihydroartemisinin for MAFLD
A Phase 1/2 study testing Dihydroartemisinin in people with MAFLD, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- MAFLD
- What is being tested?
- Dihydroartemisinin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 1 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu 210029
Nanjing, Jiangsu
Xuehao Wang, 86-025-68303211, wangxh@njmu.edu.cn
About this study
Official title: A Single-Arm, Proof-of-Concept Study of Dihydroartemisinin in Adults With Metabolic Associated Fatty Liver Disease
Brief Summary
Purpose:
Read more
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
- Being tested
- Dihydroartemisinin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydroartemisininDrug
Oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dihydroartemisinin Treatment Arm | Experimental | All enrolled participants will receive the investigational intervention: oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks. The drug is provided as 20mg tablets (Manufacturer: Beijing Fuyuan Pharmaceutical Co., Ltd.). This is followed by a 12-week post-treatment observational follow-up period. Receives: Drug: Dihydroartemisinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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
Measured: Baseline (Week 0) to End of Treatment (Week 12)
Secondary outcomes (3)
Change in Controlled Attenuation Parameter (CAP)
Absolute change in Controlled Attenuation Parameter (CAP, measured in dB/m) from baseline, as assessed by FibroScan.
Measured: 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).
Measured: Baseline (Week 0) to End of Treatment (Week 12)
Change in Body Weight
Absolute change in body weight (kg) from baseline.
Measured: Baseline (Week 0), End of Treatment (Week 12), End of Follow-up (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehao Wang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679542
- Sponsor's protocol ID
- 2026-SR-149
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Proof-of-Concept Study of Dihydroartemisinin in Adults With Metabolic Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07679542
- Acronym / sponsor ID
- 2026-SR-149
- Conditions
- MAFLD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dihydroartemisinin Treatment Arm | Experimental | Drug: DihydroartemisininAll enrolled participants will receive the investigational intervention: oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks. The drug is provided as 20mg tablets (Manufacturer: Beijing Fuyuan Pharmaceutical Co., Ltd.). This is followed by a 12-week post-treatment observational follow-up period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Aged 18-45 years (inclusive), any gender.
- Meets the diagnostic criteria for Metabolic Associated Fatty Liver Disease (MAFLD), requiring both 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DihydroartemisininOral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks | Drug | Dihydroartemisinin Treatment Arm |
Primary outcome
Change in Liver Fat Content Measured by MRI Proton Density Fat Fraction (MRI-PDFF)
Time frame: Baseline (Week 0) to End of Treatment (Week 12)
Absolute change in liver fat percentage (%) from baseline to the end of treatment, as assessed by MRI-PDFF
3 secondary outcomes
Change in Controlled Attenuation Parameter (CAP)
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)
Time frame: Baseline (Week 0) to End of Treatment (Week 12)
Change in Body Weight
Time frame: Baseline (Week 0), End of Treatment (Week 12), End of Follow-up (Week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dihydroartemisinin in people with MAFLD, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuehao Wang, Doctor (86-025-68303211, Wangxh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver Fat Content Measured by MRI Proton Density Fat Fraction (MRI-PDFF) (time frame: Baseline (Week 0) to End of Treatment (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.