MAFLDPWHNCT06940375
Incidence of Liver Disease-Related Outcomes in People With HIV
An observational study of MAFLD and Liver Fibrosis, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
Antiretroviral therapy can effectively control the replication of HIV, prolong the lifespan of patients infected with HIV, and improve their quality of life.At the same time, non-AIDS-related diseases such as diabetes and chronic liver diseases are increasing day by day.Metabolic associated fatty liver disease (MAFLD)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MAFLD, Liver Fibrosis, MASH
- What is being tested?
- Abdominal ultrasound , Fibroscan and body composition analysis examination
- Type of treatment
- Injection or infusion
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically diagnosed HIV
Who may be able to join
- Aged between 18 and 70 years old
- HIV positive individuls
- Had abdominal ultrasound and Fibroscan done between December 2019 and April 2020, with available data of LSM and CAP, and had routine follow - up at our hospital's outpatient department from April 2020 to April 2025.
Who cannot join
- Men with excessive alcohol consumption (more than 210g/week) and women with excessive alcohol consumption (more than 140g/week).
- Suffering from other liver diseases, such as viral hepatitis, drug-induced liver disease, autoimmune liver disease, decompensated liver cirrhosis, liver malignancy, or having had a liver transplantation.
- Pregnant women and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
About this study
Official title: Construction of Prediction Models for Metabolic - Associated Fatty Liver Disease and Liver Fibrosis in HIV - Infected Individuals
Antiretroviral therapy can effectively control the replication of HIV, prolong the lifespan of patients infected with HIV, and improve their quality of life.At the same time, non-AIDS-related diseases such as diabetes and chronic liver diseases are increasing day by day.Metabolic associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by overnutrition and insulin resistance in genetically susceptible individuals. It was formerly known as non-alcoholic fatty liver disease (NAFLD).With the continuous improvement of living standards and the constant change of lifestyles, the incidence of metabolic associated fatty liver disease is gradually increasing. Metabolic associated steatohepatitis (MASH) may further develop into liver cirrhosis, liver failure and hepatocellular carcinoma, and is the third most common cause of liver transplantation.
In HIV patients, early identification of significant liver fibrosis and MASH with fibrosis is of vital importance.However, due to the fact that the pathogenesis of liver fibrosis in HIV patients is more complex than that in the general population, it involves multiple factors such as the virus, reverse transcriptase drugs, chronic inflammation, and immune disorders.However, the current clinical research on metabolic-related fatty liver fibrosis in people with HIV is still rather limited.
Read the detailed description
Chronic liver injury caused by various etiologies can lead to liver fibrosis. Liver fibrosis refers to the imbalance between the synthesis and degradation of extracellular matrix in the liver under the influence of various pathogenic factors (viruses, ethanol, autoimmunity, steatosis). For HIV patients, the causes of liver fibrosis are more complex. Firstly, the impact of HIV infection itself, including chronic inflammation and immune activation caused by HIV.Secondly, the liver toxicity side effects of antiretroviral drugs and the immune reconstitution inflammatory syndrome that occurs in some patients at the beginning of treatment, causing liver inflammation and fibrosis.Third, combine various liver diseases-induced fibrosis, including metabolic associated fatty liver fibrosis, etc.In HIV patients, early identification of significant liver fibrosis and MASH with fibrosis is of vital importance. APRI and FIB-4 are currently widely used non-invasive methods for assessing the severity of liver fibrosis.However, due to the more complex pathogenesis of liver fibrosis in HIV patients compared to the general population, the accuracy of APRI and FIB-4 in diagnosis may be affected. Recently, the Fibroscan - aspartate aminotransferase (FAST) score was established to identify high-risk patients with significant liver fibrosis (F2-F4) associated with metabolic associated steatohepatitis (MASH). The FAST score was calculated using the controlled attenuation parameter (CAP), liver stiffness measurement (LSM), and aspartate aminotransferase (AST) level. Moreover, the FAST score has been validated in global clinical trials targeting metabolic associated steatohepatitis.However, in HIV-infected individuals, clinical trials targeting metabolic-associated fatty liver fibrosis are still lacking, and there is a lack of prognostic data for patients with HIV combined with MAFLD.
This study employed a retrospectively constructed cohort with prospective longitudinal follow-up. The investigators aim to Investigate the 5-year incidence and progression of hepatic steatosis and liver fibrosis in PWH using serial CAP and LSM. Additionally, the investigators intend to integrate this with metabolomics to construct prediction models for MAFLD that are suitable for HIV - infected individuals.
- Conditions
- MAFLD, Liver Fibrosis, MASH, HIV, Hepatic Steatosis, Metabolic Syndrome (MetS)
- Being tested
- Abdominal ultrasound , Fibroscan and body composition analysis examination
- Keywords
- people with HIV, metabolic associated fatty liver disease, liver fibrosis, prognosis
- Medical subject headings
- Liver Cirrhosis, Fatty Liver, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasound , Fibroscan and body composition analysis examinationOther
Also called TE, BIA
Abdominal ultrasound and Fibroscan examinations were conducted to obtain LSM, CAP, and calculate the FAST score. Bioelectrical impedance analysis was performed to obtain the content of subcutaneous and visceral fat.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who progress from non - MAFLD to MAFLD
Patients will be divided into three groups based on the different severity characteristics of metabolic-associated fatty liver disease (MAFLD).
One group consists of patients with non - metabolic - associated fatty liver. Another group is composed of patients with metabolic - associated fatty liver but not at risk of metabolic (dysfunction) - associated steatohepatitis (MASH). The last group is the one at risk of MASH.
The diagnosis of metabolic - associated fatty liver disease (MAFLD) is based on abdominal ultrasound, Fibroscan, and metabolic status.
A cutoff of FAST>0.35 is used to define MASH at risk.
Measured: Baseline
Number of participants with hepatic steatosis progression
Count and proportion of participants who, among those with a baseline controlled attenuation parameter (CAP) value less than 292 decibels per meter (dB/m), either (a) newly develop hepatic steatosis of any grade-defined per the study protocol as CAP at or above the prespecified threshold for steatosis-or (b) transition to severe hepatic steatosis, defined as CAP at or above 292 dB/m. CAP will be measured using vibration-controlled transient elastography (FibroScan device) with concurrent CAP assessment at scheduled study visits, following standardized acquisition and quality control procedures.
Measured: Baseline
Number of participants with liver fibrosis progression
Count and proportion of participants who meet either of the following criteria, with all thresholds prespecified and liver stiffness measured in kilopascals using vibration-controlled transient elastography (VCTE; FibroScan device):
- Incident significant liver fibrosis among those without significant fibrosis at baseline, defined as any follow-up liver stiffness measurement (LSM) ≥ 7.1 kPa (corresponding to fibrosis stages F2-F4 per protocol); or
- Transition to cirrhosis among those with baseline LSM ≥ 7.1 kPa and < 12.5 kPa, defined as any follow-up LSM > 12.5 kPa (corresponding to fibrosis stage F4)
Measured: Baseline
Secondary outcomes (3)
Number of participants with cardiovascular events
cardiovascular events include myocardial infarction, arrhythmia and heart failure
Measured: Baseline
Number of participants with extrahepatic tumors
these will be assessed as open-ended questions
Measured: Baseline
Lipidomic signature of MASLD-related significant fibrosis
Plasma lipidomics-derived signature to discriminate ≥F2 fibrosis, reporting AUROC, sensitivity, specificity, and optimal decision threshold (Youden's J), using same-day LSM as the reference standard. Internal cross-validation and bootstrap confidence intervals will assess robustness.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jul 2025
- Primary completion26 Feb 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yinzhong Shen, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940375
- Sponsor's protocol ID
- GKT1190
- Other IDs
- SHDC22024317
- Acronym
- PWH
- Status last verified
- May 2026
- First submitted
- 21 Mar 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Privacy Issues
Publications
Newsome PN, Sasso M, Deeks JJ, Paredes A, Boursier J, Chan WK, Yilmaz Y, Czernichow S, Zheng MH, Wong VW, Allison M, Tsochatzis E, Anstee QM, Sheridan DA, Eddowes PJ, Guha IN, Cobbold JF, Paradis V, Bedossa P, Miette V, Fournier-Poizat C, Sandrin L, Harrison SA. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):362-373. doi: 10.1016/S2468-1253(19)30383-8. Epub 2020 Feb 3.
PubMed 32027858Cervo A, Shengir M, Patel K, Sebastiani G. NASH in HIV. Curr HIV/AIDS Rep. 2020 Dec;17(6):601-614. doi: 10.1007/s11904-020-00531-0.
PubMed 32984925Kaspar MB, Sterling RK. Mechanisms of liver disease in patients infected with HIV. BMJ Open Gastroenterol. 2017 Oct 26;4(1):e000166. doi: 10.1136/bmjgast-2017-000166. eCollection 2017.
PubMed 29119002Rivera CG, Otto AO, Zeuli JD, Temesgen Z. Hepatotoxicity of contemporary antiretroviral drugs. Curr Opin HIV AIDS. 2021 Nov 1;16(6):279-285. doi: 10.1097/COH.0000000000000706.
PubMed 34545037Fan JG, Xu XY, Yang RX, Nan YM, Wei L, Jia JD, Zhuang H, Shi JP, Li XY, Sun C, Li J, Wong VW, Duan ZP; Chinese Society of Hepatology, Chinese Medical Association. Guideline for the Prevention and Treatment of Metabolic Dysfunction-associated Fatty Liver Disease (Version 2024). J Clin Transl Hepatol. 2024 Nov 28;12(11):955-974. doi: 10.14218/JCTH.2024.00311. Epub 2024 Nov 4.
PubMed 39544247Navarro J. HIV and liver disease. AIDS Rev. 2022;25(2):87-96. doi: 10.24875/AIDSRev.M22000052.
PubMed 35901073Acquired Immunodeficiency Syndrome Professional Group, Society of Infectious Diseases, Chinese Medical Association; Chinese Center for Disease Control and Prevention. Chinese guidelines for the diagnosis and treatment of human immunodeficiency virus infection/acquired immunodeficiency syndrome (2024 edition). Chin Med J (Engl). 2024 Nov 20;137(22):2654-2680. doi: 10.1097/CM9.0000000000003383. Epub 2024 Nov 18.
PubMed 39602327European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
PubMed 38851997
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Prediction Models for Metabolic - Associated Fatty Liver Disease and Liver Fibrosis in HIV - Infected Individuals
- ClinicalTrials.gov ID
- NCT06940375
- Acronym / sponsor ID
- PWH / GKT1190
- Conditions
- MAFLD, Liver Fibrosis, MASH, HIV, Hepatic Steatosis, Metabolic Syndrome (MetS)
- Keywords
- people with HIV, metabolic associated fatty liver disease, liver fibrosis, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 23 Apr 2025 (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.
Antiretroviral therapy can effectively control the replication of HIV, prolong the lifespan of patients infected with HIV, and improve their quality of life.At the same time, non-AIDS-related diseases such as diabetes and chronic liver diseases are increasing day by day.Metabolic associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by overnutrition and insulin resistance in genetically susceptible individuals. It was formerly known as non-alcoholic fatty liver disease (NAFLD).With the continuous improvement of living standards and the constant change of lifestyles, the incidence of metabolic associated fatty liver disease is gradually increasing. Metabolic associated steatohepatitis (MASH) may further develop into liver cirrhosis, liver failure and hepatocellular carcinoma, and is the third most common cause of liver transplantation.
In HIV patients, early identification of significant liver fibrosis and MASH with fibrosis is of vital importance.However, due to the fact that the pathogenesis of liver fibrosis in HIV patients is more complex than that in the general population, it involves multiple factors such as the virus, reverse transcriptase drugs, chronic inflammation, and immune disorders.However, the current clinical research on metabolic-related fatty liver fibrosis in people with HIV is still rather limited.
Detailed description
Chronic liver injury caused by various etiologies can lead to liver fibrosis. Liver fibrosis refers to the imbalance between the synthesis and degradation of extracellular matrix in the liver under the influence of various pathogenic factors (viruses, ethanol, autoimmunity, steatosis). For HIV patients, the causes of liver fibrosis are more complex. Firstly, the impact of HIV infection itself, including chronic inflammation and immune activation caused by HIV.Secondly, the liver toxicity side effects of antiretroviral drugs and the immune reconstitution inflammatory syndrome that occurs in some patients at the beginning of treatment, causing liver inflammation and fibrosis.Third, combine various liver diseases-induced fibrosis, including metabolic associated fatty liver fibrosis, etc.In HIV patients, early identification of significant liver fibrosis and MASH with fibrosis is of vital importance. APRI and FIB-4 are currently widely used non-invasive methods for assessing the severity of liver fibrosis.However, due to the more complex pathogenesis of liver fibrosis in HIV patients compared to the general population, the accuracy of APRI and FIB-4 in diagnosis may be affected. Recently, the Fibroscan - aspartate aminotransferase (FAST) score was established to identify high-risk patients with significant liver fibrosis (F2-F4) associated with metabolic associated steatohepatitis (MASH). The FAST score was calculated using the controlled attenuation parameter (CAP), liver stiffness measurement (LSM), and aspartate aminotransferase (AST) level. Moreover, the FAST score has been validated in global clinical trials targeting metabolic associated steatohepatitis.However, in HIV-infected individuals, clinical trials targeting metabolic-associated fatty liver fibrosis are still lacking, and there is a lack of prognostic data for patients with HIV combined with MAFLD.
This study employed a retrospectively constructed cohort with prospective longitudinal follow-up. The investigators aim to Investigate the 5-year incidence and progression of hepatic steatosis and liver fibrosis in PWH using serial CAP and LSM. Additionally, the investigators intend to integrate this with metabolomics to construct prediction models for MAFLD that are suitable for HIV - infected individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically diagnosed HIV
Key inclusion criteria (3 listed)
- Aged between 18 and 70 years old
- HIV positive individuls
- Had abdominal ultrasound and Fibroscan done between December 2019 and April 2020, with available data of LSM and CAP, and had routine follow - up at our hospital's outpatient department from April 2020 to April 2025.
Key exclusion criteria (3 listed)
- Men with excessive alcohol consumption (more than 210g/week) and women with excessive alcohol consumption (more than 140g/week).
- Suffering from other liver diseases, such as viral hepatitis, drug-induced liver disease, autoimmune liver disease, decompensated liver cirrhosis, liver malignancy, or having had a liver transplantation.
- Pregnant women and lactating women.
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 |
|---|---|---|
| Abdominal ultrasound , Fibroscan and body composition analysis examinationAlso: TE, BIAAbdominal ultrasound and Fibroscan examinations were conducted to obtain LSM, CAP, and calculate the FAST score. Bioelectrical impedance analysis was performed to obtain the content of subcutaneous and visceral fat. | Other | – |
Primary outcome
Number of patients who progress from non - MAFLD to MAFLD
Time frame: Baseline
Patients will be divided into three groups based on the different severity characteristics of metabolic-associated fatty liver disease (MAFLD). One group consists of patients with non - metabolic - associated fatty liver. Another group is composed of patients with metabolic - associated fatty liver but not at risk of metabolic (dysfunction) - associated steatohepatitis (MASH). The last group is the one at risk of MASH. The diagnosis of metabolic - associated fatty liver disease (MAFLD) is based on abdominal ultrasound, Fibroscan, and metabolic status. A cutoff of FAST>0.35 is used to define MASH at risk.
Number of participants with hepatic steatosis progression
Time frame: Baseline
Count and proportion of participants who, among those with a baseline controlled attenuation parameter (CAP) value less than 292 decibels per meter (dB/m), either (a) newly develop hepatic steatosis of any grade-defined per the study protocol as CAP at or above the prespecified threshold for steatosis-or (b) transition to severe hepatic steatosis, defined as CAP at or above 292 dB/m. CAP will be measured using vibration-controlled transient elastography (FibroScan device) with concurrent CAP assessment at scheduled study visits, following standardized acquisition and quality control procedures.
Number of participants with liver fibrosis progression
Time frame: Baseline
Count and proportion of participants who meet either of the following criteria, with all thresholds prespecified and liver stiffness measured in kilopascals using vibration-controlled transient elastography (VCTE; FibroScan device): 1. Incident significant liver fibrosis among those without significant fibrosis at baseline, defined as any follow-up liver stiffness measurement (LSM) ≥ 7.1 kPa (corresponding to fibrosis stages F2-F4 per protocol); or 2. Transition to cirrhosis among those with baseline LSM ≥ 7.1 kPa and < 12.5 kPa, defined as any follow-up LSM > 12.5 kPa (corresponding to fibrosis stage F4)
3 secondary outcomes
Number of participants with cardiovascular events
Time frame: Baseline
Number of participants with extrahepatic tumors
Time frame: Baseline
Lipidomic signature of MASLD-related significant fibrosis
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Results publication: PubMed 32027858Newsome PN, Sasso M, Deeks JJ, Paredes A, Boursier J, Chan WK, Yilmaz Y, Czernichow S, Zheng MH, Wong VW, Allison M, Tsochatzis E, Anstee QM, Sheridan DA, Eddowes PJ, Guha IN, Cobbold JF, Paradis V, Bedossa P, Miette V, Fournier-Poizat C, Sandrin L, Harrison SA. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):362-373. doi: 10.1016/S2468-1253(19)30383-8. Epub 2020 Feb 3.
- Results publication: PubMed 32984925Cervo A, Shengir M, Patel K, Sebastiani G. NASH in HIV. Curr HIV/AIDS Rep. 2020 Dec;17(6):601-614. doi: 10.1007/s11904-020-00531-0.
- Results publication: PubMed 29119002Kaspar MB, Sterling RK. Mechanisms of liver disease in patients infected with HIV. BMJ Open Gastroenterol. 2017 Oct 26;4(1):e000166. doi: 10.1136/bmjgast-2017-000166. eCollection 2017.
- Results publication: PubMed 34545037Rivera CG, Otto AO, Zeuli JD, Temesgen Z. Hepatotoxicity of contemporary antiretroviral drugs. Curr Opin HIV AIDS. 2021 Nov 1;16(6):279-285. doi: 10.1097/COH.0000000000000706.
- Results publication: PubMed 39544247Fan JG, Xu XY, Yang RX, Nan YM, Wei L, Jia JD, Zhuang H, Shi JP, Li XY, Sun C, Li J, Wong VW, Duan ZP; Chinese Society of Hepatology, Chinese Medical Association. Guideline for the Prevention and Treatment of Metabolic Dysfunction-associated Fatty Liver Disease (Version 2024). J Clin Transl Hepatol. 2024 Nov 28;12(11):955-974. doi: 10.14218/JCTH.2024.00311. Epub 2024 Nov 4.
- Results publication: PubMed 35901073Navarro J. HIV and liver disease. AIDS Rev. 2022;25(2):87-96. doi: 10.24875/AIDSRev.M22000052.
- Results publication: PubMed 39602327Acquired Immunodeficiency Syndrome Professional Group, Society of Infectious Diseases, Chinese Medical Association; Chinese Center for Disease Control and Prevention. Chinese guidelines for the diagnosis and treatment of human immunodeficiency virus infection/acquired immunodeficiency syndrome (2024 edition). Chin Med J (Engl). 2024 Nov 20;137(22):2654-2680. doi: 10.1097/CM9.0000000000003383. Epub 2024 Nov 18.
- Results publication: PubMed 38851997European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
- Individual participant dataSharing planned: No. Patient Privacy Issues
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MAFLD and Liver Fibrosis, run by Shanghai Public Health Clinical Center 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jun 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who progress from non - MAFLD to MAFLD (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940375, which also lists 8 linked publications.
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 2 Jun 2026.