Dapagliflozin Efficacy and Action in NASH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2024-03-28

Brief Summary

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This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.

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Detailed Description

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Conditions

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Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dapagliflozin group

Participants will receive dapagliflozin 10mg po qd.

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Participants will receive dapagliflozin 10mg po qd

Placebo group

Participants will receive placebo po qd.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive placebo po qd

Interventions

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Dapagliflozin

Participants will receive dapagliflozin 10mg po qd

Intervention Type DRUG

Placebo

Participants will receive placebo po qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women aged≥18 years;
* Non-alcoholic steatohepatitis as determined by liver biopsies within 6 months;
* Patients with T2DM at screening had to have stable glycaemic control (HbA1c \<9.5%) .

Exclusion Criteria

1. Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
2. A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
3. Obstructive biliary disease;
4. Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
5. Poor glucose control (defined as HbA1C≤ 9.5% within 3 months) if diagnosed with T2DM, or taking any antidiabetic medication that would affect metabolism or weight loss (i.e. TZD, GLP-1, DPP-4i or initially using insulin in the past 3 months);
6. Taking any medication (i.e. cortisol, methotrexate)that would affect steatohepatitis for more than two weeks in the past year;
7. Chronic kidney disease or severe impaired renal function (serum creatinine≥ 2.0mg/dl);
8. Serum alanine aminotransferase (ALT) greater than 300U/L
9. A history of Type 1 diabetes;
10. A history of bladder cancer;
11. Women who are pregnant or plan to become pregnant;
12. Serious medical disease with likely life expectancy less than 5 years;
13. Patients who cannot be followed for 24 months (due to a health situation or migration);
14. Participation in other clinical trial in the 30 days before randomization;
15. Patients who are unwilling or unable to give informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No