Dapagliflozin Efficacy and Action in NASH (DEAN)

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 3

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03723252

NFEC-2018-127

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

Dapagliflozin group

Experimental group

Description:

Participants will receive dapagliflozin 10mg po qd.

Treatment:

Drug: Dapagliflozin

Placebo group

Placebo Comparator group

Description:

Participants will receive placebo po qd.

Treatment:

Drug: Placebo