Fatty LiverPhase 3NCT05308160
A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease
A Phase 3 study testing Dapagliflozin 10Mg Tab in people with Fatty Liver, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Dapagliflozin 10Mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jun 2021to 30 Apr 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study patients should fulfil the following criteria:
- Provision of informed consent prior to the time of registration.
- Aged 20-74 years male or female who are diagnosed with NAFLD and FibroScan shows CAP score ≥ 252 dB/m (≥Steatosis grade 2).
- 3.30 or more mL/min/1.73 m2 of estimated glomerular filtration rate 4.Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 1 month after the last dose of IP to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
- 5.Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.
Who cannot join
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Viral hepatitis or other types of liver disorder (e.g. drug-induced or autoimmune hepatitis).
- Alcohol consumption above recommended limits (male: more than 30g/ day; female: more than 20g/day converting to ethanol).
- Serious liver dysfunction (Child-Pugh B or C).
- History of any other malignancy within 1 years (with the exception of successfully treated non-melanoma skin cancers).
- Patients with a known hypersensitivity to investigator product (IP).
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- Participation in another clinical trial within the previous 30 days or involvement in the planning and/or conduct of the study.
- Previous enrolment or randomisation in the present study.
- Active gallbladder diseases
- For women is currently pregnant (confirmed with positive pregnancy test) or breast feeding.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei, Zhongzheng Dist., 100229
Tzu Meng Weng, +886-2312-3456 ext. 66579, wengmengtzu@gmail.com
About this study
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.
- Conditions
- Fatty Liver
- Being tested
- Dapagliflozin 10Mg Tab, Placebo
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.
PlaceboDrug
This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. Receives: Drug: Dapagliflozin 10Mg Tab |
| Non-used drug | Placebo comparator | This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome Measure
Patients who meet all inclusion criteria and none of the exclusion criteria and are not screen failures for reasons listed above will be randomized in a 1:1 ratio to either receive 10 mg per day dapagliflozin or enter control group at Visit 2.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start28 Jun 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308160
- Sponsor's protocol ID
- 202104098MIPC
- Status last verified
- Jun 2021
- First submitted
- 7 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05308160
- Acronym / sponsor ID
- 202104098MIPC
- Conditions
- Fatty Liver
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 1 Apr 2022 (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 trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: Dapagliflozin 10Mg TabThis trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. |
| Non-used drug | Placebo comparator | Drug: PlaceboThis trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to the time of registration.
- Aged 20-74 years male or female who are diagnosed with NAFLD and FibroScan shows CAP score ≥ 252 dB/m (≥Steatosis grade 2).
- 3.30 or more mL/min/1.73 m2 of estimated glomerular filtration rate 4.Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 1 month after the last dose of IP to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
- 5.Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.
Key exclusion criteria (10 listed)
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Viral hepatitis or other types of liver disorder (e.g. drug-induced or autoimmune hepatitis).
- Alcohol consumption above recommended limits (male: more than 30g/ day; female: more than 20g/day converting to ethanol).
- Serious liver dysfunction (Child-Pugh B or C).
- History of any other malignancy within 1 years (with the exception of successfully treated non-melanoma skin cancers).
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 |
|---|---|---|
| Dapagliflozin 10Mg TabThis trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca. | Drug | Dapagliflozin |
| PlaceboThis trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca. | Drug | Non-used drug |
Primary outcome
Safety Outcome Measure
Time frame: 6 months
Patients who meet all inclusion criteria and none of the exclusion criteria and are not screen failures for reasons listed above will be randomized in a 1:1 ratio to either receive 10 mg per day dapagliflozin or enter control group at Visit 2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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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.
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 10Mg Tab in people with Fatty Liver, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Apr 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu Meng Weng (+886-2312-3456 ext. 66579, wengmengtzu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome Measure (time frame: 6 months). 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 1 Apr 2022.