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

NCT ID: NCT05308160

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2024-04-30

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.

Conditions

Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dapagliflozin

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.

Group Type: ACTIVE_COMPARATOR

Dapagliflozin 10Mg Tab

Intervention Type: DRUG

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.

Non-used drug

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Dapagliflozin 10Mg Tab

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NTUH

Taipei, Zhongzheng Dist., Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tzu Meng Weng

Role: CONTACT

wengmengtzu@gmail.com

+886-2312-3456 ext. 66579

Facility Contacts

Tzu Meng Weng

Role: primary

wengmengtzu@gmail.com

+886-2312-3456 ext. 66579

Other Identifiers

202104098MIPC

Identifier Type: -

Identifier Source: org_study_id