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NCT03723252: DEAN
Dapagliflozin Efficacy and Action in NASH
Phase 3 trial testing Dapagliflozin in Nonalcoholic Steatohepatitis in 154 participants. Completed in 28 March 2024.
22 March 2024
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 154 |
| Start date | 20 March 2019 |
| Primary completion | 22 March 2024 |
| Estimated completion | 28 March 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
- Placebo
Conditions studied
- Nonalcoholic Steatohepatitis — all drugs for Nonalcoholic Steatohepatitis →
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):
-
NAFLD: Mechanisms, Treatments, and Biomarkers.
Nassir F. · · 2022 · cited 245× · PMID 35740949 · DOI 10.3390/biom12060824 -
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 -
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 -
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 -
Metabolic Targets in Nonalcoholic Fatty Liver Disease.
Esler WP, Bence KK. · · 2019 · cited 105× · PMID 31004828 · DOI 10.1016/j.jcmgh.2019.04.007 -
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 -
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 -
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:
- PubMed search for NCT03723252
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Nonalcoholic Steatohepatitis
Currently open trials in the same condition.
- NCT07481734 — Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) · Phase 2 · recruiting
- NCT06465186 — A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017) · Phase 2 · active not recruiting
- NCT05526144 — Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans · Phase 2 · recruiting
- NCT05330923 — Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease · recruiting
- NCT04550481 — Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study · Phase 2 · active not recruiting
Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
- NCT07091994 — A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy · Phase 4 · not yet recruiting
- NCT06444022 — hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation · Phase 1 · withdrawn
- NCT07537777 — Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted T · Phase 2 · not yet recruiting
- NCT07481032 — Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients · NA · not yet recruiting
- NCT07511894 — Beta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03723252 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanfang Hospital, Southern Medical University
- Last refreshed: 29 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03723252.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing