Dapagliflozin Efficacy and Action in NASH

Nonalcoholic Steatohepatitis Clinical Trial

— DEAN  

Official title:

Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis: a Multicentre, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723252
• Other study ID #: NFEC-2018-127
• Status: Completed
• Phase: Phase 3
• Start date: March 20, 2019
• Est. completion date: March 28, 2024

Study information

• Verified date: March 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 28, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• Dapagliflozin
Participants will receive dapagliflozin 10mg po qd
• Placebo
Participants will receive placebo po qd

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in scored liver histological improvement over 12 months		Baseline to 12 months
Secondary	Resolution of NASH	defined as a hepatocellular ballooning score of 0, and lobular inflammation score of 0 or 1) without worsening of fibrosis	Baseline to 12 months
Secondary	Improvement of fibrosis	defined as reduction in fibrosis of at least 1 stage) without worsening of NASH	Baseline to 12 months
Secondary	Change in fibrosis score		Baseline to 12 months
Secondary	Change in each component score in the NAS		Baseline to 12 months
Secondary	Change in body weight		Baseline to 12 months
Secondary	Change in waist circumference		Baseline to 12 months
Secondary	Change in visceral fat		Baseline to 12 months
Secondary	Change in liver fat		Baseline to 12 months
Secondary	Change in HbA1C		Baseline to 12 months
Secondary	Change in blood pressure		Baseline to 12 months
Secondary	Change in serum lipids		Baseline to 12 months
Secondary	Change in insulin resistance		Baseline to 12 months
Secondary	Change in inflammatory markers of NASH		Baseline to 12 months
Secondary	Change in health related quality of life scores (SF-36)		Baseline to 12 months