Dapagliflozin Efficacy and Action in NASH

NCT03723252 | Completed Phase 3

• 1 other identifier: NFEC-2018-127
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic Steatohepatitis; SGLT-2 inhibitor

Outcome Measures

Primary Outcomes (1)

• Improvement in scored liver histological improvement over 12 months

  Baseline to 12 months

Secondary Outcomes (14)

• Resolution of NASH

  Baseline to 12 months

• Improvement of fibrosis

  Baseline to 12 months

• Change in fibrosis score

  Baseline to 12 months

• Change in each component score in the NAS

  Baseline to 12 months

• Change in body weight

  Baseline to 12 months

Study Arms (2)

Dapagliflozin group

EXPERIMENTAL

Participants will receive dapagliflozin 10mg po qd.

Drug: Dapagliflozin

Placebo group

PLACEBO COMPARATOR

Participants will receive placebo po qd.

Drug: Placebo

Interventions

Dapagliflozin DRUG

Participants will receive dapagliflozin 10mg po qd

Dapagliflozin group

Placebo DRUG

Participants will receive placebo po qd

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%) .

You may not qualify if:

• Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
• A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
• Obstructive biliary disease;
• Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
• 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);
• Taking any medication (i.e. cortisol, methotrexate)that would affect steatohepatitis for more than two weeks in the past year;
• Chronic kidney disease or severe impaired renal function (serum creatinine≥ 2.0mg/dl);
• Serum alanine aminotransferase (ALT) greater than 300U/L
• A history of Type 1 diabetes;
• A history of bladder cancer;
• Women who are pregnant or plan to become pregnant;
• Serious medical disease with likely life expectancy less than 5 years;
• Patients who cannot be followed for 24 months (due to a health situation or migration);
• Participation in other clinical trial in the 30 days before randomization;
• Patients who are unwilling or unable to give informed consent.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

• Lin J, Huang Y, Xu B, Gu X, Huang J, Sun J, Jia L, He J, Huang C, Wei X, Chen J, Chen X, Zhou J, Wu L, Zhang P, Zhu Y, Xia H, Wen G, Liu Y, Liu S, Zeng Y, Zhou L, Jia H, He H, Xue Y, Wu F, Zhang H. Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial. BMJ. 2025 Jun 4;389:e083735. doi: 10.1136/bmj-2024-083735.

  PMID: 40467095 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Huijie Zhang, MD.PhD.

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 29, 2018
• Study Start: March 20, 2019
• Primary Completion: March 22, 2024
• Study Completion: March 28, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)