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

NCT05308160 | Unknown Phase 3

• 1 other identifier: 202104098MIPC
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Dapagliflozin 10Mg Tab 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.

Dapagliflozin

Placebo 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

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, Zhongzheng Dist., 100229, Taiwan

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Tzu Meng Weng

CONTACT

+886-2312-3456; wengmengtzu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 1, 2022
• Study Start: June 28, 2021
• Primary Completion: June 30, 2023
• Study Completion: April 30, 2024
• Last Updated: April 1, 2022

Record last verified: 2021-06

Locations

TW (1)