Dapagliflozin Efficacy and Action in NASH

Phase 3

Completed

• Conditions: Nonalcoholic Steatohepatitis
• Interventions: Drug: Dapagliflozin; Drug: Placebo

• Registration Number: NCT03723252
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Study Start: 2019-03-20
• Status Verified: 2024-03
• Primary Completion: 2024-03-22
• Study Completion: 2024-03-28
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin group	Dapagliflozin	Participants will receive dapagliflozin 10mg po qd.
Placebo group	Placebo	Participants will receive placebo po qd.

Primary Outcome Measures

Name	Time	Method
Improvement in scored liver histological improvement over 12 months	Baseline to 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China