A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease

National Taiwan University

Status and phase: Unknown; Phase 3

Conditions: Fatty Liver

Treatments: Drug: Placebo; Drug: Dapagliflozin 10Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05308160

202104098MIPC

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups, including a placebo group

Dapagliflozin

Active Comparator group

Description:

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.

Treatment:

Drug: Dapagliflozin 10Mg Tab

Non-used drug

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo