Non-alcoholic Fatty Liver DiseasePhase 4NCT02649465
SGLT2 Inhibitor Versus Sulfonylurea on Type 2 Diabetes With NAFLD
A Phase 4 study testing Tofogliflozin and Glimepiride in people with Non-alcoholic Fatty Liver Disease, run by Kanazawa University at 1 site in Japan.
Trial summary
The clinicopathological analyses revealed that reduction in HbA1c and use of insulin independently contribute to the reduction in liver fibrosis scores during the histological course of NAFLD development. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Tofogliflozin and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 11 Nov 2015to 30 Jun 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Hepatic virus infections (hepatitis B and C, cytomegalovirus, and Epstein-Barr virus), autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, alpha 1-antitrypsin deficiency, Wilson's disease, history of parenteral nutrition.
- Use of agents known to induce steatosis (e.g., valproate, amiodarone, or vitamin E)
- Hepatic injury caused by substance abuse.
- Current consumption of more than 20 g of alcohol daily.
- Hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding
- Elevated serum bilirubin level of more than two-fold the upper normal limit.
Show all 20Show fewer
- Tofogliflozin or glimepiride hypersensitivity or contraindications.
- History of type 1 diabetes.
- History of ketoacidosis.
- History of symptoms of severe hypoglycemia.
- Treatment with SGLT2 inhibitor including tofogliflozin within 4 weeks of screening.
- Treatment with glinide and sulfonylurea use within 4 weeks of screening.
- Concomitant corticosteroid therapy uses within 4 weeks of screening.
- Poorly controlled unstable diabetes (ketoacidosis or an increase in HbA1c of >3% in the 12 weeks before screening).
- Poorly controlled hypertension or systolic blood pressure of >160 mmHg or diastolic blood pressure of >100 mmHg.
- Artificial dialysis or moderate renal dysfunction.
- Poorly controlled dyslipidemia.
- Presence of a severe health problem, not being suitable for the study.
- Pregnant or breastfeeding.
- Inability to participate in the study (including psychiatric and psychosocial problems), as assessed by the investigators.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Kanazawa University Graduate School of Medical Sciences
Kanazawa, Ishikawa-ken, 920-8640
About this study
Official title: Pleiotropic Effects and Safety of Sodium Glucose Co-transporter 2 Inhibitor Versus Sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver
The clinicopathological analyses revealed that reduction in HbA1c and use of insulin independently contribute to the reduction in liver fibrosis scores during the histological course of NAFLD development. These findings led us to hypothesize that glycemic control and insulin ameliorate or protect against the histological progression of liver fibrosis in patients with NAFLD.
In the present study, we investigated the efficacy of SGLT2 inhibitor tofogliflozin and sulfonylurea glimepiride, which lower glucose levels similarly with reduction and elevation in circulating insulin levels, respectively, in NAFLD patients with type 2 diabetes for 48 weeks by examining liver histology, as well as hepatic enzymes, metabolic markers, and hepatic gene expression profiles.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD), ranging from simple fatty liver to nonalcoholic steatohepatitis (NASH), is a liver phenotype of metabolic disorders, such as diabetes, obesity, and metabolic syndrome. NAFLD and type 2 diabetes share epidemiological and pathophysiological features. Specifically, hyperglycemia is closely associated with liver fibrosis, which is associated with liver cirrhosis, hepatocellular carcinoma, and prognosis in patients with NASH.
To date, some anti-diabetic agents have been tested in patients with NAFLD. The guidelines in the Asian Pacific, European, and American association recommended the administration of PPAR gamma agonist (pioglitazone) and glucagon-like peptide receptor agonists (GLP1RA) for the treatment of diabetes with NAFLD/NASH. However, there are concerns about adverse effects such as weight gain, edema, fractures, and carcinogenesis in pioglitazone or gastrointestinal adverse effects and medication burden as an injection in GLP1 RA. In addition, because all of these anti-diabetic agents significantly reduced glycemic levels compared with placebo, liver histological improvement may be theoretically attributable to glucose reduction itself.
Both sodium-glucose cotransporter 2 (SGLT2) inhibitors and sulfonylureas are chosen as the second-line therapy when glycemic control cannot be achieved with metformin or as the first-line therapy when metformin is contraindicated or not tolerated. In animal models of NAFLD/NASH, SGLT2 inhibitors protect against steatosis, inflammation, and fibrosis. Previous clinical trials have demonstrated that SGLT2 inhibitors exert protective effects on liver enzymes and liver steatosis in patients with NAFLD/NASH. However, these studies lack a control group or histological examination, which precludes meaningful conclusions since the natural course of the disease or tight glycemic control may ameliorate liver histology in some patients with NAFLD. Sulfonylureas are still reliable and potent antidiabetic agents in insulinopenic patients with type 2 diabetes and therefore are used as the second-line therapy, especially when the cost is a significant issue. Besides, sulfonylureas reduce glucose and elevate weight, which may render positive and negative effects, respectively, on liver pathology in NAFLD/NASH. In the phase 3 trial, canagliflozin was non-inferior to glimepiride for reduction of HbA1c at 52 weeks. However, the differences between SGLT2 inhibitors and sulfonylureas on NAFLD patients with type 2 diabetes under similar glucose reduction remain uncertain.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Tofogliflozin, Glimepiride
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofogliflozinDrug
Also called DEBERZA
The group receiving Tofogliflozin (at a dose of 20mg once daily) for 48 weeks
GlimepirideDrug
Sulfonylurea dosage (Glimepiride): dosing from 0.5 mg for initial 4 weeks. Then, if there is no adverse effect or no improvement of glucose metabolism, glimepiride is escalated to 6 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 inhibitor | Active comparator | N=20 SGLT2 inhibitor dosage (Tofogliflozin): a dose of 20mg once daily for 48 weeks. Receives: Drug: Tofogliflozin |
| Sulfonylurea | Active comparator | N=20 Sulfonylurea (Glimepiride): an initial dose of 0.5 mg once daily for 48 weeks. Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement in histologic features of NAFLD
Measured: 48 weeks
Secondary outcomes (21)
Change from baseline in liver enzymes
Measured: 48 weeks
Change from baseline in body composition
Measured: 48 weeks
Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test
Measured: 48 weeks
Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study
Measured: 48 weeks
Change from baseline in lipid profile
Measured: 48 weeks
Change from baseline in renal function and electrolyte balances
Measured: 48 weeks
Change from baseline in oxidative stress
Measured: 48 weeks
Change from baseline in cytokine (TNF-alpha, leptin, adiponectin) levels
Measured: 48 weeks
Change from baseline in hepatokine (Selenoprotein P, LECT2) levels
Measured: 48 weeks
Change from baseline in organ-specific fat accumulation
Measured: 48 weeks
Change from baseline in oxidative and non-oxidative glucose disposal
Measured: 48 weeks
Change from baseline in respiratory quotients
Measured: 48 weeks
Change from baseline in energy expenditure
Measured: 48 weeks
Change from baseline in autonomic nerve function.
Measured: 48 weeks
Changes from baseline in minerals and bone metabolism
Measured: 48 weeks
Changes from baseline in endothelial functions
Measured: 48 weeks
Changes from baseline in fatty acids profiles
Measured: 48 weeks
Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response.
Measured: 48 weeks
Changes from baseline in gene expression profiles in the liver and blood cells
Measured: 48 weeks
Changes from baseline in microRNAs and exosome contents
Measured: 48 weeks
Epigenomic changes from baseline in genes of the liver and blood cells
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start11 Nov 2015
- Primary completion28 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanazawa University
- Sponsor type
- University, hospital or other
- Collaborators
- Kowa Company, Ltd.
- Responsible party
- Principal investigator, Toshinari Takamura, MD, PhD, Kanazawa University
- Investigators
- Toshinari Takamura, MD,PhD, Study chair, Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649465
- Sponsor's protocol ID
- CRB4180005
- Status last verified
- Jun 2021
- First submitted
- 5 Jan 2016
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The datasets are not readily available because several studies are ongoing using the datasets in the present study. Requests to access the datasets should be directed to the correspondence author. We will open raw data with the appropriate institutional ethics committee's prior approval.
Publications
Yasuda K, Iida N, Takeshita Y, Masuo Y, Honda M, Takamura T, Yamashita T. Tofogliflozin alters amino acid metabolism in gut microbiota linked to hepatic transcriptomic signatures in MASLD. J Gastroenterol. 2026 Jul 30. doi: 10.1007/s00535-026-02488-0. Online ahead of print.
PubMed 42530605Takeshita Y, Honda M, Harada K, Kita Y, Takata N, Tsujiguchi H, Tanaka T, Goto H, Nakano Y, Iida N, Arai K, Yamashita T, Mizukoshi E, Nakamura H, Kaneko S, Takamura T. Comparison of Tofogliflozin and Glimepiride Effects on Nonalcoholic Fatty Liver Disease in Participants With Type 2 Diabetes: A Randomized, 48-Week, Open-Label, Active-Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):2064-2075. doi: 10.2337/dc21-2049.
PubMed 35894933Takeshita Y, Kanamori T, Tanaka T, Kaikoi Y, Kita Y, Takata N, Iida N, Arai K, Yamashita T, Harada K, Gabata T, Nakamura H, Kaneko S, Takamura T. Study Protocol for Pleiotropic Effects and Safety of Sodium-Glucose Cotransporter 2 Inhibitor Versus Sulfonylurea in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease. Diabetes Ther. 2020 Feb;11(2):549-560. doi: 10.1007/s13300-020-00762-9. Epub 2020 Jan 20.
PubMed 31956961
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleiotropic Effects and Safety of Sodium Glucose Co-transporter 2 Inhibitor Versus Sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver
- ClinicalTrials.gov ID
- NCT02649465
- Acronym / sponsor ID
- CRB4180005
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kanazawa UniversityUniversity, hospital or other
- Collaborators
- Kowa Company, Ltd.
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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.
The clinicopathological analyses revealed that reduction in HbA1c and use of insulin independently contribute to the reduction in liver fibrosis scores during the histological course of NAFLD development. These findings led us to hypothesize that glycemic control and insulin ameliorate or protect against the histological progression of liver fibrosis in patients with NAFLD.
In the present study, we investigated the efficacy of SGLT2 inhibitor tofogliflozin and sulfonylurea glimepiride, which lower glucose levels similarly with reduction and elevation in circulating insulin levels, respectively, in NAFLD patients with type 2 diabetes for 48 weeks by examining liver histology, as well as hepatic enzymes, metabolic markers, and hepatic gene expression profiles.
Detailed description
Nonalcoholic fatty liver disease (NAFLD), ranging from simple fatty liver to nonalcoholic steatohepatitis (NASH), is a liver phenotype of metabolic disorders, such as diabetes, obesity, and metabolic syndrome. NAFLD and type 2 diabetes share epidemiological and pathophysiological features. Specifically, hyperglycemia is closely associated with liver fibrosis, which is associated with liver cirrhosis, hepatocellular carcinoma, and prognosis in patients with NASH.
To date, some anti-diabetic agents have been tested in patients with NAFLD. The guidelines in the Asian Pacific, European, and American association recommended the administration of PPAR gamma agonist (pioglitazone) and glucagon-like peptide receptor agonists (GLP1RA) for the treatment of diabetes with NAFLD/NASH. However, there are concerns about adverse effects such as weight gain, edema, fractures, and carcinogenesis in pioglitazone or gastrointestinal adverse effects and medication burden as an injection in GLP1 RA. In addition, because all of these anti-diabetic agents significantly reduced glycemic levels compared with placebo, liver histological improvement may be theoretically attributable to glucose reduction itself.
Both sodium-glucose cotransporter 2 (SGLT2) inhibitors and sulfonylureas are chosen as the second-line therapy when glycemic control cannot be achieved with metformin or as the first-line therapy when metformin is contraindicated or not tolerated. In animal models of NAFLD/NASH, SGLT2 inhibitors protect against steatosis, inflammation, and fibrosis. Previous clinical trials have demonstrated that SGLT2 inhibitors exert protective effects on liver enzymes and liver steatosis in patients with NAFLD/NASH. However, these studies lack a control group or histological examination, which precludes meaningful conclusions since the natural course of the disease or tight glycemic control may ameliorate liver histology in some patients with NAFLD. Sulfonylureas are still reliable and potent antidiabetic agents in insulinopenic patients with type 2 diabetes and therefore are used as the second-line therapy, especially when the cost is a significant issue. Besides, sulfonylureas reduce glucose and elevate weight, which may render positive and negative effects, respectively, on liver pathology in NAFLD/NASH. In the phase 3 trial, canagliflozin was non-inferior to glimepiride for reduction of HbA1c at 52 weeks. However, the differences between SGLT2 inhibitors and sulfonylureas on NAFLD patients with type 2 diabetes under similar glucose reduction remain uncertain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 inhibitor | Active comparator | Drug: TofogliflozinN=20 SGLT2 inhibitor dosage (Tofogliflozin): a dose of 20mg once daily for 48 weeks. |
| Sulfonylurea | Active comparator | Drug: GlimepirideN=20 Sulfonylurea (Glimepiride): an initial dose of 0.5 mg once daily for 48 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Hepatic virus infections (hepatitis B and C, cytomegalovirus, and Epstein-Barr virus), autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, alpha 1-antitrypsin deficiency, Wilson's disease, history of parenteral nutrition.
- Use of agents known to induce steatosis (e.g., valproate, amiodarone, or vitamin E)
- Hepatic injury caused by substance abuse.
- Current consumption of more than 20 g of alcohol daily.
- Hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding
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 |
|---|---|---|
| TofogliflozinAlso: DEBERZAThe group receiving Tofogliflozin (at a dose of 20mg once daily) for 48 weeks | Drug | SGLT2 inhibitor |
| GlimepirideSulfonylurea dosage (Glimepiride): dosing from 0.5 mg for initial 4 weeks. Then, if there is no adverse effect or no improvement of glucose metabolism, glimepiride is escalated to 6 mg once daily. | Drug | Sulfonylurea |
Primary outcome
The improvement in histologic features of NAFLD
Time frame: 48 weeks
21 secondary outcomes
Change from baseline in liver enzymes
Time frame: 48 weeks
Change from baseline in body composition
Time frame: 48 weeks
Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test
Time frame: 48 weeks
Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study
Time frame: 48 weeks
Change from baseline in lipid profile
Time frame: 48 weeks
Change from baseline in renal function and electrolyte balances
Time frame: 48 weeks
Change from baseline in oxidative stress
Time frame: 48 weeks
Change from baseline in cytokine (TNF-alpha, leptin, adiponectin) levels
Time frame: 48 weeks
Change from baseline in hepatokine (Selenoprotein P, LECT2) levels
Time frame: 48 weeks
Change from baseline in organ-specific fat accumulation
Time frame: 48 weeks
Change from baseline in oxidative and non-oxidative glucose disposal
Time frame: 48 weeks
Change from baseline in respiratory quotients
Time frame: 48 weeks
Change from baseline in energy expenditure
Time frame: 48 weeks
Change from baseline in autonomic nerve function.
Time frame: 48 weeks
Changes from baseline in minerals and bone metabolism
Time frame: 48 weeks
Changes from baseline in endothelial functions
Time frame: 48 weeks
Changes from baseline in fatty acids profiles
Time frame: 48 weeks
Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response.
Time frame: 48 weeks
Changes from baseline in gene expression profiles in the liver and blood cells
Time frame: 48 weeks
Changes from baseline in microRNAs and exosome contents
Time frame: 48 weeks
Epigenomic changes from baseline in genes of the liver and blood cells
Time frame: 48 weeks
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 Jul 2021.
- Derived from this study: PubMed 42530605Yasuda K, Iida N, Takeshita Y, Masuo Y, Honda M, Takamura T, Yamashita T. Tofogliflozin alters amino acid metabolism in gut microbiota linked to hepatic transcriptomic signatures in MASLD. J Gastroenterol. 2026 Jul 30. doi: 10.1007/s00535-026-02488-0. Online ahead of print.
- Derived from this study: PubMed 35894933Takeshita Y, Honda M, Harada K, Kita Y, Takata N, Tsujiguchi H, Tanaka T, Goto H, Nakano Y, Iida N, Arai K, Yamashita T, Mizukoshi E, Nakamura H, Kaneko S, Takamura T. Comparison of Tofogliflozin and Glimepiride Effects on Nonalcoholic Fatty Liver Disease in Participants With Type 2 Diabetes: A Randomized, 48-Week, Open-Label, Active-Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):2064-2075. doi: 10.2337/dc21-2049.
- Derived from this study: PubMed 31956961Takeshita Y, Kanamori T, Tanaka T, Kaikoi Y, Kita Y, Takata N, Iida N, Arai K, Yamashita T, Harada K, Gabata T, Nakamura H, Kaneko S, Takamura T. Study Protocol for Pleiotropic Effects and Safety of Sodium-Glucose Cotransporter 2 Inhibitor Versus Sulfonylurea in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease. Diabetes Ther. 2020 Feb;11(2):549-560. doi: 10.1007/s13300-020-00762-9. Epub 2020 Jan 20.
- Individual participant dataSharing planned: No. The datasets are not readily available because several studies are ongoing using the datasets in the present study. Requests to access the datasets should be directed to the correspondence author. We will open raw data with the appropriate institutional ethics committee's prior approval.
Related trials for Non-alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
Toshinari Takamura, MD,PhD study chair
Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences,
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 Tofogliflozin and Glimepiride in people with Non-alcoholic Fatty Liver Disease, run by Kanazawa University at 1 site in Japan.
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 0 inclusion and 20 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 Jul 2021. 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 Japan. 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 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?
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?
The improvement in histologic features of NAFLD (time frame: 48 weeks). 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 NCT02649465, which also lists 3 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 Jul 2021.