Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)NCT07433205
Study on Risk Factors and Prognosis of MASLD
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This longitudinal cohort study will enroll individuals with MASLD (and/or those at risk) and follow them over time to identify clinical and metabolic risk factors for disease progression and to evaluate predictors of long-term outcomes, including fibrosis progression and liver-related events, major cardiovascular… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- How many people
- 922 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 2 Years
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 20-90 years will be enrolled into a prospective observational cohort, including participants with MASLD and a comparison cohort without MASLD at baseline, recruited from the same source population. Participants will undergo standardized clinical assessment, laboratory testing, and noninvasive liver evaluation at baseline and during follow-up for up to 2 years to assess metabolic risk factors, MASLD progression, and clinical outcomes.
Who may be able to join
- Age 20 to 90 years at enrollment. Able and willing to provide written informed consent. Willing and able to comply with study assessments and follow-up for up to 2 years.
- Availability of baseline clinical evaluation and laboratory tests required by the protocol.
- For the MASLD cohort: Evidence of hepatic steatosis at baseline (e.g., imaging and/or noninvasive assessment) in the presence of metabolic dysfunction, consistent with contemporary MASLD criteria, and without alternative causes of steatosis per protocol.
- For the Control cohort: No evidence of MASLD/ hepatic steatosis at baseline (based on available imaging and/or noninvasive assessment), recruited from the same source population.
Who cannot join
- Significant alcohol consumption exceeding protocol-defined thresholds. Known chronic liver diseases other than MASLD (including but not limited to chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency).
- History of hepatocellular carcinoma, liver transplantation, or other active malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ) that may interfere with follow-up.
- Decompensated liver disease at baseline (e.g., ascites, variceal bleeding, hepatic encephalopathy) if not intended to be included per protocol.
- Use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic corticosteroids, tamoxifen) within a protocol-defined period, if judged to be the primary cause of steatosis.
- Pregnancy or breastfeeding at enrollment (if applicable to your protocol assessments).
- Any serious medical condition or psychiatric disorder that, in the investigator's opinion, would make participation unsafe or interfere with study assessments or follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan University affiliated Chengdu Second People's Hospital
Chengdu, Sichuan, 610041
About this study
Official title: Risk Factors and Prognosis of Metabolic Dysfunction-Associated Steatotic Liver Disease
This longitudinal cohort study will enroll individuals with MASLD (and/or those at risk) and follow them over time to identify clinical and metabolic risk factors for disease progression and to evaluate predictors of long-term outcomes, including fibrosis progression and liver-related events, major cardiovascular events, and all-cause mortality.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Participants without MASLD at baseline, serving as a comparison cohort. Individuals will be recruited from the same source population as the MASLD cohort and will undergo the same standardized baseline assessment and follow-up schedule, including clinical evaluation, laboratory testing, and noninvasive liver assessment as applicable. Participants will be followed for incident MASLD and longitudinal changes in metabolic risk factors and clinical outcomes during the study period. | |
| MASLD | Participants with MASLD at baseline, defined according to contemporary clinical criteria based on evidence of hepatic steatosis in the presence of metabolic dysfunction and in the absence of alternative causes of steatosis as specified in the protocol. Participants will undergo standardized baseline assessment and longitudinal follow-up, including clinical evaluation, laboratory testing, and noninvasive liver assessment (e.g., transient elastography and/or other validated measures as available). Follow-up will evaluate MASLD progression (including worsening steatosis and/or fibrosis) and the occurrence of clinical outcomes, such as liver-related events and major cardiovascular events, as well as all-cause mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis progression (noninvasive)
Change in liver fibrosis stage/risk assessed by transient elastography (liver stiffness measurement, LSM) and/or validated fibrosis scores (e.g., FIB-4, NAFLD Fibrosis Score).
Measured: Baseline to 2 years.
Composite liver-related clinical events
Incidence of liver-related events (composite), including hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), new diagnosis of cirrhosis, hepatocellular carcinoma, liver transplantation, or liver-related death.
Measured: Baseline to 2 years.
Secondary outcomes (2)
Steatosis change
Change in hepatic steatosis assessed by CAP (controlled attenuation parameter) and/or imaging (ultrasound/CT/MRI-PDFF if available).
Measured: Baseline to 2 years.
Liver enzymes improvement/worsening
Change in ALT and AST levels.
Measured: Baseline to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 922 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuesong Wen, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Xuesong Doctor, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433205
- Sponsor's protocol ID
- 20260220
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prognosis of Metabolic Dysfunction-Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07433205
- Acronym / sponsor ID
- 20260220
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Feb 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.
This longitudinal cohort study will enroll individuals with MASLD (and/or those at risk) and follow them over time to identify clinical and metabolic risk factors for disease progression and to evaluate predictors of long-term outcomes, including fibrosis progression and liver-related events, major cardiovascular events, and all-cause mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Participants without MASLD at baseline, serving as a comparison cohort. Individuals will be recruited from the same source population as the MASLD cohort and will undergo the same standardized baseline assessment and follow-up schedule, including clinical evaluation, laboratory testing, and noninvasive liver assessment as applicable. Participants will be followed for incident MASLD and longitudinal changes in metabolic risk factors and clinical outcomes during the study period. |
| MASLD | – | –Participants with MASLD at baseline, defined according to contemporary clinical criteria based on evidence of hepatic steatosis in the presence of metabolic dysfunction and in the absence of alternative causes of steatosis as specified in the protocol. Participants will undergo standardized baseline assessment and longitudinal follow-up, including clinical evaluation, laboratory testing, and noninvasive liver assessment (e.g., transient elastography and/or other validated measures as available). Follow-up will evaluate MASLD progression (including worsening steatosis and/or fibrosis) and the occurrence of clinical outcomes, such as liver-related events and major cardiovascular events, as well as all-cause mortality. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 20-90 years will be enrolled into a prospective observational cohort, including participants with MASLD and a comparison cohort without MASLD at baseline, recruited from the same source population. Participants will undergo standardized clinical assessment, laboratory testing, and noninvasive liver evaluation at baseline and during follow-up for up to 2 years to assess metabolic risk factors, MASLD progression, and clinical outcomes.
Key inclusion criteria (4 listed)
- Age 20 to 90 years at enrollment. Able and willing to provide written informed consent. Willing and able to comply with study assessments and follow-up for up to 2 years.
- Availability of baseline clinical evaluation and laboratory tests required by the protocol.
- For the MASLD cohort: Evidence of hepatic steatosis at baseline (e.g., imaging and/or noninvasive assessment) in the presence of metabolic dysfunction, consistent with contemporary MASLD criteria, and without alternative causes of steatosis per protocol.
- For the Control cohort: No evidence of MASLD/ hepatic steatosis at baseline (based on available imaging and/or noninvasive assessment), recruited from the same source population.
Key exclusion criteria (6 listed)
- Significant alcohol consumption exceeding protocol-defined thresholds. Known chronic liver diseases other than MASLD (including but not limited to chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency).
- History of hepatocellular carcinoma, liver transplantation, or other active malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ) that may interfere with follow-up.
- Decompensated liver disease at baseline (e.g., ascites, variceal bleeding, hepatic encephalopathy) if not intended to be included per protocol.
- Use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic corticosteroids, tamoxifen) within a protocol-defined period, if judged to be the primary cause of steatosis.
- Pregnancy or breastfeeding at enrollment (if applicable to your protocol assessments).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibrosis progression (noninvasive)
Time frame: Baseline to 2 years.
Change in liver fibrosis stage/risk assessed by transient elastography (liver stiffness measurement, LSM) and/or validated fibrosis scores (e.g., FIB-4, NAFLD Fibrosis Score).
Composite liver-related clinical events
Time frame: Baseline to 2 years.
Incidence of liver-related events (composite), including hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), new diagnosis of cirrhosis, hepatocellular carcinoma, liver transplantation, or liver-related death.
2 secondary outcomes
Steatosis change
Time frame: Baseline to 2 years.
Liver enzymes improvement/worsening
Time frame: Baseline to 2 years.
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 25 Feb 2026.
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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.
Xuesong Doctor study chair
First Affiliated Hospital of Chongqing Medical University
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 Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), run by First Affiliated Hospital of Chongqing 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 4 inclusion and 6 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 25 Feb 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?
Fibrosis progression (noninvasive) (time frame: Baseline to 2 years.). The study lists 2 primary outcomes in all. 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 25 Feb 2026.