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NCT03723252: DEAN

Dapagliflozin Efficacy and Action in NASH

Completed Phase 3 Last updated 29 March 2024
What this trial tests

Phase 3 trial testing Dapagliflozin in Nonalcoholic Steatohepatitis in 154 participants. Completed in 28 March 2024.

Timeline
20 March 2019
Primary endpoint
22 March 2024
28 March 2024

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment154
Start date20 March 2019
Primary completion22 March 2024
Estimated completion28 March 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

18 and older, any sex, with Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. NAFLD: Mechanisms, Treatments, and Biomarkers.
    Nassir F. · · 2022 · cited 245× · PMID 35740949 · DOI 10.3390/biom12060824
  2. Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH).
    Xu X, Poulsen KL, Wu L, Liu S, et al · · 2022 · cited 235× · PMID 35963848 · DOI 10.1038/s41392-022-01119-3
  3. Pathogenesis and treatment of non-alcoholic steatohepatitis and its fibrosis.
    Lee KC, Wu PS, Lin HC. · · 2023 · cited 145× · PMID 36226471 · DOI 10.3350/cmh.2022.0237
  4. An international multidisciplinary consensus statement on MAFLD and the risk of CVD.
    Zhou XD, Targher G, Byrne CD, Somers V, et al · · 2023 · cited 134× · PMID 37204656 · DOI 10.1007/s12072-023-10543-8
  5. Metabolic Targets in Nonalcoholic Fatty Liver Disease.
    Esler WP, Bence KK. · · 2019 · cited 105× · PMID 31004828 · DOI 10.1016/j.jcmgh.2019.04.007
  6. Metabolic liver disease in diabetes - From mechanisms to clinical trials.
    Dewidar B, Kahl S, Pafili K, Roden M. · · 2020 · cited 96× · PMID 32569680 · DOI 10.1016/j.metabol.2020.154299
  7. Metabolic dysfunction-associated fatty liver disease (MAFLD): an update of the recent advances in pharmacological treatment.
    Sangro P, de la Torre Aláez M, Sangro B, D'Avola D. · · 2023 · cited 91× · PMID 36976456 · DOI 10.1007/s13105-023-00954-4
  8. Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease.
    Fraile JM, Palliyil S, Barelle C, Porter AJ, et al · · 2021 · cited 91× · PMID 34588764 · DOI 10.2147/dddt.s315724

Verify or expand the search:

Other trials of Dapagliflozin

Trials testing the same drug.

Other recruiting trials for Nonalcoholic Steatohepatitis

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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