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

Primary Purpose

Fatty Liver

Status
Recruiting
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Dapagliflozin 10Mg Tab
Placebo
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NTUHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dapagliflozin

Non-used drug

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2022
Last Updated
March 31, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05308160
Brief 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
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Active Comparator
Arm 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.
Arm Title
Non-used drug
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10Mg Tab
Intervention 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. 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
Intervention Name(s)
Placebo
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Safety Outcome Measure
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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. Exclusion criteria 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu Meng Weng
Phone
+886-2312-3456
Ext
66579
Email
wengmengtzu@gmail.com
Facility Information:
Facility Name
NTUH
City
Taipei City
State/Province
Zhongzheng Dist.
ZIP/Postal Code
100229
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzu Meng Weng
Phone
+886-2312-3456
Ext
66579
Email
wengmengtzu@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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