Nonalcoholic SteatohepatitisPhase 3DEANNCT03723252
Dapagliflozin Efficacy and Action in NASH
A Phase 3 study testing Dapagliflozin in people with Nonalcoholic Steatohepatitis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 28 Mar 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged≥18 years;
- Non-alcoholic steatohepatitis as determined by liver biopsies within 6 months;
- Patients with T2DM at screening had to have stable glycaemic control (HbA1c <9.5%) .
Who cannot join
- Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
- A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
- Obstructive biliary disease;
- Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
- Poor glucose control (defined as HbA1C≤ 9.5% within 3 months) if diagnosed with T2DM, or taking any antidiabetic medication that would affect metabolism or weight loss (i.e. TZD, GLP-1, DPP-4i or initially using insulin in the past 3 months);
- Taking any medication (i.e. cortisol, methotrexate)that would affect steatohepatitis for more than two weeks in the past year;
Show all 15Show fewer
- Chronic kidney disease or severe impaired renal function (serum creatinine≥ 2.0mg/dl);
- Serum alanine aminotransferase (ALT) greater than 300U/L
- A history of Type 1 diabetes;
- A history of bladder cancer;
- Women who are pregnant or plan to become pregnant;
- Serious medical disease with likely life expectancy less than 5 years;
- Patients who cannot be followed for 24 months (due to a health situation or migration);
- Participation in other clinical trial in the 30 days before randomization;
- Patients who are unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis: a Multicentre, Randomized, Placebo-controlled Trial
This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- Dapagliflozin, Placebo
- Keywords
- Nonalcoholic Steatohepatitis, SGLT-2 inhibitor
- 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.
DapagliflozinDrug
Participants will receive dapagliflozin 10mg po qd
PlaceboDrug
Participants will receive placebo po qd
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Experimental | Participants will receive dapagliflozin 10mg po qd. Receives: Drug: Dapagliflozin |
| Placebo group | Placebo comparator | Participants will receive placebo po qd. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in scored liver histological improvement over 12 months
Measured: Baseline to 12 months
Secondary outcomes (14)
Resolution of NASH
defined as a hepatocellular ballooning score of 0, and lobular inflammation score of 0 or 1) without worsening of fibrosis
Measured: Baseline to 12 months
Improvement of fibrosis
defined as reduction in fibrosis of at least 1 stage) without worsening of NASH
Measured: Baseline to 12 months
Change in fibrosis score
Measured: Baseline to 12 months
Change in each component score in the NAS
Measured: Baseline to 12 months
Change in body weight
Measured: Baseline to 12 months
Change in waist circumference
Measured: Baseline to 12 months
Change in visceral fat
Measured: Baseline to 12 months
Change in liver fat
Measured: Baseline to 12 months
Change in HbA1C
Measured: Baseline to 12 months
Change in blood pressure
Measured: Baseline to 12 months
Change in serum lipids
Measured: Baseline to 12 months
Change in insulin resistance
Measured: Baseline to 12 months
Change in inflammatory markers of NASH
Measured: Baseline to 12 months
Change in health related quality of life scores (SF-36)
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start20 Mar 2019
- Primary completion22 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijie Zhang, Nanfang Hospital, Southern Medical University
- Investigators
- Huijie Zhang, MD.PhD., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723252
- Sponsor's protocol ID
- NFEC-2018-127
- Acronym
- DEAN
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2018
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin J, Huang Y, Xu B, Gu X, Huang J, Sun J, Jia L, He J, Huang C, Wei X, Chen J, Chen X, Zhou J, Wu L, Zhang P, Zhu Y, Xia H, Wen G, Liu Y, Liu S, Zeng Y, Zhou L, Jia H, He H, Xue Y, Wu F, Zhang H. Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial. BMJ. 2025 Jun 4;389:e083735. doi: 10.1136/bmj-2024-083735.
PubMed 40467095
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis: a Multicentre, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03723252
- Acronym / sponsor ID
- DEAN / NFEC-2018-127
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- Nonalcoholic Steatohepatitis, SGLT-2 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 29 Oct 2018 (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 is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Experimental | Drug: DapagliflozinParticipants will receive dapagliflozin 10mg po qd. |
| Placebo group | Placebo comparator | Drug: PlaceboParticipants will receive placebo po qd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged≥18 years;
- Non-alcoholic steatohepatitis as determined by liver biopsies within 6 months;
- Patients with T2DM at screening had to have stable glycaemic control (HbA1c <9.5%) .
Key exclusion criteria (15 listed)
- Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
- A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
- Obstructive biliary disease;
- Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
- Poor glucose control (defined as HbA1C≤ 9.5% within 3 months) if diagnosed with T2DM, or taking any antidiabetic medication that would affect metabolism or weight loss (i.e. TZD, GLP-1, DPP-4i or initially using insulin in the past 3 months);
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 |
|---|---|---|
| DapagliflozinParticipants will receive dapagliflozin 10mg po qd | Drug | Dapagliflozin group |
| PlaceboParticipants will receive placebo po qd | Drug | Placebo group |
Primary outcome
Improvement in scored liver histological improvement over 12 months
Time frame: Baseline to 12 months
14 secondary outcomes
Resolution of NASH
Time frame: Baseline to 12 months
Improvement of fibrosis
Time frame: Baseline to 12 months
Change in fibrosis score
Time frame: Baseline to 12 months
Change in each component score in the NAS
Time frame: Baseline to 12 months
Change in body weight
Time frame: Baseline to 12 months
Change in waist circumference
Time frame: Baseline to 12 months
Change in visceral fat
Time frame: Baseline to 12 months
Change in liver fat
Time frame: Baseline to 12 months
Change in HbA1C
Time frame: Baseline to 12 months
Change in blood pressure
Time frame: Baseline to 12 months
Change in serum lipids
Time frame: Baseline to 12 months
Change in insulin resistance
Time frame: Baseline to 12 months
Change in inflammatory markers of NASH
Time frame: Baseline to 12 months
Change in health related quality of life scores (SF-36)
Time frame: Baseline to 12 months
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 29 Mar 2024.
- Derived from this study: PubMed 40467095Lin J, Huang Y, Xu B, Gu X, Huang J, Sun J, Jia L, He J, Huang C, Wei X, Chen J, Chen X, Zhou J, Wu L, Zhang P, Zhu Y, Xia H, Wen G, Liu Y, Liu S, Zeng Y, Zhou L, Jia H, He H, Xue Y, Wu F, Zhang H. Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial. BMJ. 2025 Jun 4;389:e083735. doi: 10.1136/bmj-2024-083735.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huijie Zhang, MD.PhD. principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin in people with Nonalcoholic Steatohepatitis, run by Nanfang Hospital, Southern 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 3 inclusion and 15 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 29 Mar 2024. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Improvement in scored liver histological improvement over 12 months (time frame: Baseline to 12 months). 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 NCT03723252, which also lists 1 linked publication.
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 29 Mar 2024.