Clinical trial NCT05308160: A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fatty Liver
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.


Eligibility criteria: Inclusion criteria

For inclusion in the study patients should fulfil the following criteria:

1. Provision of informed consent prior to the time of registration.
2. 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.

Exclusion criteria

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

1. Viral hepatitis or other types of liver disorder (e.g. drug-induced or autoimmune hepatitis).
2. Alcohol consumption above recommended limits (male: more than 30g/ day; female: more than 20g/day converting to ethanol).
3. Serious liver dysfunction (Child-Pugh B or C).
4. History of any other malignancy within 1 years (with the exception of successfully treated non-melanoma skin cancers).
5. Patients with a known hypersensitivity to investigator product (IP).
6. Participation in another clinical trial within the previous 30 days or involvement in the planning and/or conduct of the study.
7. Previous enrolment or randomisation in the present study.
8. Active gallbladder diseases
9. For women is currently pregnant (confirmed with positive pregnancy test) or breast feeding.

Primary outcomes:
measure: Safety Outcome Measure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: NTUH
state: Zhongzheng Dist.
Study officials:
References: