Chronic Hepatitis bPhase 4NCT05147090
Effects of Empagliflozin on Fibrosis and Cirrhosis in Chronic Hepatitis B Patients
A Phase 4 study testing Empagliflozin 10 MG in people with Chronic Hepatitis b and NAFLD, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Chronic hepatitis B (CHB) affects 257million individuals worldwide. In 2017, it caused around 39.7 million cases of cirrhosis and 0.4 million cirrhosis-related deaths in 2017. However, there is no specific treatment for liver fibrosis/cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis b, NAFLD, Cirrhosis
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jan 2022to 31 Dec 2027
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be recruited if they have significant/advanced fibrosis or cirrhosis confirmed by MRE
Who cannot join
- decompensated cirrhosis (variceal bleeding, ascites, hepatic hydrothorax, hepatic encephalopathy),
- portal vein thrombosis,
- alcohol intake >20g within last 2 years,
- concurrent chronic liver disease (chronic hepatitis C infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cholangitis, drug-induced),
- history of malignancy including hepatocellular carcinoma (HCC),
- pregnancy,
- contraindications to empagliflozin (estimated glomerular filtration rate (eGFR) <45mL/min/1.73m2, recurrent genitourinary tract infections, gangrene, allergy),
- contraindications to MRI (e.g., claustrophobia, implanted devices with ferromagnetic properties).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong/Queen Mary Hospital
Hong Kong, Hong Kong, China, 852
About this study
Official title: Effects of Empagliflozin on Preventing Fibrosis and Cirrhosis Progression in Nucleos(t)Ide Analogue-treated Chronic Hepatitis B Patients With F2-F4 Fibrosis: a Randomized, Double-blind Placebo-controlled Trial
Chronic hepatitis B (CHB) affects 257million individuals worldwide. In 2017, it caused around 39.7 million cases of cirrhosis and 0.4 million cirrhosis-related deaths in 2017. However, there is no specific treatment for liver fibrosis/cirrhosis. Although nucleos(t)ide analogues (NAs) profoundly suppress viral replication, fibrosis/cirrhosis progression can still occur in NA-treated patients.
Sodium-glucose cotransporter type-2 (SGLT2) inhibitors are antidiabetic drugs that may prevent fibrosis/cirrhosis progression by reducing hepatic steatosis/inflammation, dampening renin-angiotensin aldosterone system (RAAS) activation, and reducing fluid retention, effects of which are independent of glycemic control. Clinical studies in diabetic patients show SGLT2 inhibitors reduce hepatis steatosis/inflammation, regress ascites (a cirrhotic complication), and improve liver function parameters and survival prognosis in terms of model for end-stage liver disease (MELD) score. There are currently no randomized controlled trials (RCTs) on role of SGLT2 inhibitors in preventing fibrosis/cirrhosis progression in CHB patients. Magnetic resonance elastography (MRE) and transient elastography (TE) are non-invasive techniques for liver stiffness measurement (LSM), although MRE is more accurate than TE.
Read more
The investigators propose a double-blind, randomized, placebo-controlled trial to compare effect of empagliflozin (an SGLT2 inhibitor) with placebo (1:1 ratio) in preventing fibrosis progression in both diabetic and non-diabetic NA-treated CHB patients with significant/advanced fibrosis or compensated cirrhosis. 108 patients will be randomly sampled from our pre-existing TE database. Empagliflozin 10mg daily will be given to treatment arm. Placebo pills will be manufactured identical in appearance to empagliflozin. Subjects will receive active or placebo pills for three years, and undergo clinical, anthropometric and laboratory assessments (at baseline, weeks 8, 16, and every 4 months thereafter). They will undergo LSM by TE at baseline, end of first, second and third year, and by MRE at baseline and end of third year. Primary outcome is difference in change to liver stiffness (measured by MRE) from baseline between the two groups at the end of third year.
The study results will determine whether SGLT2 inhibitors can prevent hepatic fibrosis/cirrhosis progression in NA-treated CHB patients.
Read the detailed description
Chronic hepatitis B (CHB) affects 257million individuals worldwide. In 2017, it caused around 39.7 million cases of cirrhosis and 0.4 million cirrhosis-related deaths in 2017. However, there is no specific treatment for liver fibrosis/cirrhosis. Although nucleos(t)ide analogues (NAs) profoundly suppress viral replication, fibrosis/cirrhosis progression can still occur in NA-treated patients.
Sodium-glucose cotransporter type-2 (SGLT2) inhibitors are antidiabetic drugs that may prevent fibrosis/cirrhosis progression by reducing hepatic steatosis/inflammation, dampening renin-angiotensin aldosterone system (RAAS) activation, and reducing fluid retention, effects of which are independent of glycemic control. Clinical studies in diabetic patients show SGLT2 inhibitors reduce hepatis steatosis/inflammation, regress ascites (a cirrhotic complication), and improve liver function parameters and survival prognosis in terms of model for end-stage liver disease (MELD) score. Our preliminary data from a territory-wide electronic healthcare database shows SGLT2 inhibitors were associated with 58% reduction in risk of cirrhosis development over three years among CHB patients with diabetes (n=9,502). There are currently no randomized controlled trials (RCTs) on role of SGLT2 inhibitors in preventing fibrosis/cirrhosis progression in CHB patients. Magnetic resonance elastography (MRE) and transient elastography (TE) are non-invasive techniques for liver stiffness measurement (LSM), although MRE is more accurate than TE.
The novelty of utilizing "drug repositioning" by changing role of SGLT2 inhibitors in treating diabetes mellitus (DM) to preventing fibrosis/cirrhosis progression in CHB deserves exploration. We propose a double-blind, randomized, placebo-controlled trial to compare effect of empagliflozin (an SLGT2 inhibitor) with placebo (1:1 ratio) in reducing liver stiffness in both diabetic and non-diabetic NA-treated CHB patients with significant/advanced fibrosis or compensated cirrhosis. 108 patients will be randomly sampled from our pre-existing TE database. Empagliflozin 10mg daily will be given to treatment arm. Placebo pills will be manufactured identical in appearance to empagliflozin. Subjects will receive active or placebo pills for three years, and undergo clinical, anthropometric and laboratory assessments (at baseline, weeks 8, 16, and every 4 months thereafter). They will undergo LSM by TE at baseline, end of first, second and third year, and by MRE at baseline and end of third year. Primary outcome is difference in change to liver stiffness (measured by MRE) from baseline between the two groups at the end of third year. Secondary outcomes are remission of advanced fibrosis/cirrhosis, progression of advanced fibrosis to cirrhosis, improvement of laboratory results (liver transaminases, ferritin, glucose, lipid profiles) and anthropometric measurements.
The study results will determine whether SGLT2 inhibitors can prevent hepatic fibrosis/cirrhosis progression in NA-treated CHB patients.
- Conditions
- Chronic Hepatitis b, NAFLD, Cirrhosis, Fibrosis, Liver, Empagliflozin, SGLT2 Inhibitors
- Being tested
- Empagliflozin 10 MG, Placebo pills
- Medical subject headings
- Hepatitis B, Chronic, Non-alcoholic Fatty Liver Disease, Fibrosis, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called empagliflozin
Empagliflozin 10mg daily
Placebo pillsDrug
Also called placebo
Identical in appearance to empagliflozin 10mg daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin group | Active comparator | Empagliflozin 10mg daily for 156 weeks Receives: Drug: Empagliflozin 10 MG |
| Placebo group | Placebo comparator | Placebo pills (identical in appearance to empagliflozin 10mg) daily for 156 weeks Receives: Drug: Placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver stiffness (measured by MRE)
difference in change to liver stiffness from baseline between the two groups at the end of year 3 as measured by MRE
Measured: week 156
Secondary outcomes (19)
Remission of significant/advanced fibrosis and cirrhosis
Remission of advanced fibrosis and cirrhosis (defined as a decrease in 1 fibrosis stage using MRE) at the end of year 3
Measured: week 156
Progression of significant/advanced fibrosis to cirrhosis (measured by MRE)
Progression of significant/advanced fibrosis to cirrhosis (as defined by MRE) at the end of year 3
Measured: week 156
Progression to decompensated cirrhosis
Progression to decompensated cirrhosis (ascites, variceal bleeding and/or hepatic encephalopathy) at the end of year 3
Measured: week 156
Change in liver stiffness (measured by transient elastography)
Difference in serial changes to liver stiffness from baseline between the two groups (LSM measured by transient elastography)
Measured: week 26, 52, 104 and 156
Change in fat content (measured by transient elastography)
Difference in serial changes to liver fat content from baseline between the two groups (CAP measured by transient elastography)
Measured: week 26, 52, 104 and 156
Changes of alanine aminotransferase (ALT)
Changes of ALT at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of aspartate aminotransferase (AST)
Changes of AST at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of alkaline phosphatase (ALP)
Changes of ALP at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of gamma glutamyl transferase (GGT)
Changes of GGT at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of fasting glucose
Changes of fasting glucose at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of haemoglobin A1c (HbA1c)
Changes of HbA1c at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of total cholesterol
Changes of total cholesterol at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of low density lipoprotein (LDL)
Changes of LDL at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of high density lipoprotein (HDL)
Changes of HDL at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of body weight
Changes of body weight at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of body mass index (BMI)
Changes of BMI at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of waist circumference
Changes of waist circumference at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of systolic blood pressure
Changes of systolic blood pressure at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Changes of diastolic blood pressure
Changes of diastolic blood pressure at week 26, 52, 104 and 156
Measured: week 26, 52, 104 and 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start2 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomly allocated to either the empagliflozin group or placebo group (i.e. control group)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grant Council
- Responsible party
- Sponsor
- Investigators
- Ka Shing Cheung, MD, MPH, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147090
- Sponsor's protocol ID
- UW-21023
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be made available in the form of excel files upon request by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Empagliflozin on Preventing Fibrosis and Cirrhosis Progression in Nucleos(t)Ide Analogue-treated Chronic Hepatitis B Patients With F2-F4 Fibrosis: a Randomized, Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05147090
- Acronym / sponsor ID
- UW-21023
- Conditions
- Chronic Hepatitis b, NAFLD, Cirrhosis, Fibrosis, Liver, Empagliflozin, SGLT2 Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Research Grant Council
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Dec 2021 (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.
Chronic hepatitis B (CHB) affects 257million individuals worldwide. In 2017, it caused around 39.7 million cases of cirrhosis and 0.4 million cirrhosis-related deaths in 2017. However, there is no specific treatment for liver fibrosis/cirrhosis. Although nucleos(t)ide analogues (NAs) profoundly suppress viral replication, fibrosis/cirrhosis progression can still occur in NA-treated patients.
Sodium-glucose cotransporter type-2 (SGLT2) inhibitors are antidiabetic drugs that may prevent fibrosis/cirrhosis progression by reducing hepatic steatosis/inflammation, dampening renin-angiotensin aldosterone system (RAAS) activation, and reducing fluid retention, effects of which are independent of glycemic control. Clinical studies in diabetic patients show SGLT2 inhibitors reduce hepatis steatosis/inflammation, regress ascites (a cirrhotic complication), and improve liver function parameters and survival prognosis in terms of model for end-stage liver disease (MELD) score. There are currently no randomized controlled trials (RCTs) on role of SGLT2 inhibitors in preventing fibrosis/cirrhosis progression in CHB patients. Magnetic resonance elastography (MRE) and transient elastography (TE) are non-invasive techniques for liver stiffness measurement (LSM), although MRE is more accurate than TE.
The investigators propose a double-blind, randomized, placebo-controlled trial to compare effect of empagliflozin (an SGLT2 inhibitor) with placebo (1:1 ratio) in preventing fibrosis progression in both diabetic and non-diabetic NA-treated CHB patients with significant/advanced fibrosis or compensated cirrhosis. 108 patients will be randomly sampled from our pre-existing TE database. Empagliflozin 10mg daily will be given to treatment arm. Placebo pills will be manufactured identical in appearance to empagliflozin. Subjects will receive active or placebo pills for three years, and undergo clinical, anthropometric and laboratory assessments (at baseline, weeks 8, 16, and every 4 months thereafter). They will undergo LSM by TE at baseline, end of first, second and third year, and by MRE at baseline and end of third year. Primary outcome is difference in change to liver stiffness (measured by MRE) from baseline between the two groups at the end of third year.
The study results will determine whether SGLT2 inhibitors can prevent hepatic fibrosis/cirrhosis progression in NA-treated CHB patients.
Detailed description
Chronic hepatitis B (CHB) affects 257million individuals worldwide. In 2017, it caused around 39.7 million cases of cirrhosis and 0.4 million cirrhosis-related deaths in 2017. However, there is no specific treatment for liver fibrosis/cirrhosis. Although nucleos(t)ide analogues (NAs) profoundly suppress viral replication, fibrosis/cirrhosis progression can still occur in NA-treated patients.
Sodium-glucose cotransporter type-2 (SGLT2) inhibitors are antidiabetic drugs that may prevent fibrosis/cirrhosis progression by reducing hepatic steatosis/inflammation, dampening renin-angiotensin aldosterone system (RAAS) activation, and reducing fluid retention, effects of which are independent of glycemic control. Clinical studies in diabetic patients show SGLT2 inhibitors reduce hepatis steatosis/inflammation, regress ascites (a cirrhotic complication), and improve liver function parameters and survival prognosis in terms of model for end-stage liver disease (MELD) score. Our preliminary data from a territory-wide electronic healthcare database shows SGLT2 inhibitors were associated with 58% reduction in risk of cirrhosis development over three years among CHB patients with diabetes (n=9,502). There are currently no randomized controlled trials (RCTs) on role of SGLT2 inhibitors in preventing fibrosis/cirrhosis progression in CHB patients. Magnetic resonance elastography (MRE) and transient elastography (TE) are non-invasive techniques for liver stiffness measurement (LSM), although MRE is more accurate than TE.
The novelty of utilizing "drug repositioning" by changing role of SGLT2 inhibitors in treating diabetes mellitus (DM) to preventing fibrosis/cirrhosis progression in CHB deserves exploration. We propose a double-blind, randomized, placebo-controlled trial to compare effect of empagliflozin (an SLGT2 inhibitor) with placebo (1:1 ratio) in reducing liver stiffness in both diabetic and non-diabetic NA-treated CHB patients with significant/advanced fibrosis or compensated cirrhosis. 108 patients will be randomly sampled from our pre-existing TE database. Empagliflozin 10mg daily will be given to treatment arm. Placebo pills will be manufactured identical in appearance to empagliflozin. Subjects will receive active or placebo pills for three years, and undergo clinical, anthropometric and laboratory assessments (at baseline, weeks 8, 16, and every 4 months thereafter). They will undergo LSM by TE at baseline, end of first, second and third year, and by MRE at baseline and end of third year. Primary outcome is difference in change to liver stiffness (measured by MRE) from baseline between the two groups at the end of third year. Secondary outcomes are remission of advanced fibrosis/cirrhosis, progression of advanced fibrosis to cirrhosis, improvement of laboratory results (liver transaminases, ferritin, glucose, lipid profiles) and anthropometric measurements.
The study results will determine whether SGLT2 inhibitors can prevent hepatic fibrosis/cirrhosis progression in NA-treated CHB patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomly allocated to either the empagliflozin group or placebo group (i.e. control group)
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin group | Active comparator | Drug: Empagliflozin 10 MGEmpagliflozin 10mg daily for 156 weeks |
| Placebo group | Placebo comparator | Drug: Placebo pillsPlacebo pills (identical in appearance to empagliflozin 10mg) daily for 156 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be recruited if they have significant/advanced fibrosis or cirrhosis confirmed by MRE
Key exclusion criteria (8 listed)
- decompensated cirrhosis (variceal bleeding, ascites, hepatic hydrothorax, hepatic encephalopathy),
- portal vein thrombosis,
- alcohol intake >20g within last 2 years,
- concurrent chronic liver disease (chronic hepatitis C infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cholangitis, drug-induced),
- history of malignancy including hepatocellular carcinoma (HCC),
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 |
|---|---|---|
| Empagliflozin 10 MGAlso: empagliflozinEmpagliflozin 10mg daily | Drug | Empagliflozin group |
| Placebo pillsAlso: placeboIdentical in appearance to empagliflozin 10mg daily | Drug | Placebo group |
Primary outcome
Change in liver stiffness (measured by MRE)
Time frame: week 156
difference in change to liver stiffness from baseline between the two groups at the end of year 3 as measured by MRE
19 secondary outcomes
Remission of significant/advanced fibrosis and cirrhosis
Time frame: week 156
Progression of significant/advanced fibrosis to cirrhosis (measured by MRE)
Time frame: week 156
Progression to decompensated cirrhosis
Time frame: week 156
Change in liver stiffness (measured by transient elastography)
Time frame: week 26, 52, 104 and 156
Change in fat content (measured by transient elastography)
Time frame: week 26, 52, 104 and 156
Changes of alanine aminotransferase (ALT)
Time frame: week 26, 52, 104 and 156
Changes of aspartate aminotransferase (AST)
Time frame: week 26, 52, 104 and 156
Changes of alkaline phosphatase (ALP)
Time frame: week 26, 52, 104 and 156
Changes of gamma glutamyl transferase (GGT)
Time frame: week 26, 52, 104 and 156
Changes of fasting glucose
Time frame: week 26, 52, 104 and 156
Changes of haemoglobin A1c (HbA1c)
Time frame: week 26, 52, 104 and 156
Changes of total cholesterol
Time frame: week 26, 52, 104 and 156
Changes of low density lipoprotein (LDL)
Time frame: week 26, 52, 104 and 156
Changes of high density lipoprotein (HDL)
Time frame: week 26, 52, 104 and 156
Changes of body weight
Time frame: week 26, 52, 104 and 156
Changes of body mass index (BMI)
Time frame: week 26, 52, 104 and 156
Changes of waist circumference
Time frame: week 26, 52, 104 and 156
Changes of systolic blood pressure
Time frame: week 26, 52, 104 and 156
Changes of diastolic blood pressure
Time frame: week 26, 52, 104 and 156
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 30 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be made available in the form of excel files upon request by other researchers
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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.
Ka Shing Cheung, MD, MPH principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 MG in people with Chronic Hepatitis b and NAFLD, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 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 Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Change in liver stiffness (measured by MRE) (time frame: week 156). 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 30 Jan 2026.