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Peer-reviewedCC BYNature Medicine

Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial

  • Lee M. Kaplan1,2
  • Elena Startseva3
  • Carel Wynand le Roux4,5
  • Sean Wharton6,7
  • Biykem Bozkurt8
  • Daniel Ferraz de Campos Mazo3
  • Jessica von Schlippenbach9
  • Sandra González Maldonado10
  • Samina Ajaz Hussain3
  • Guy W. Neff11
  • Yaneicy Gonzalez Rojas12
  • Charles Smith11
34 more authors
  • Ramy Younes3
  • Arun Jayant Sanyal13
  • on behalf of the SYNCHRONIZE-MASLD Investigators
  • Antonio O. Martin
  • Juan Manuel Pericàs
  • Mark Leibowitz14
  • Douglas Scott Denham15
  • Kevin Korenblat16
  • Michael Herman17
  • Shekhar Challa18
  • Rasha Youssef19
  • Masi Khaja20
  • Apinya Vutikullird21
  • Humberto Aguilar22
  • Naga Chalasani23
  • James Maher24
  • Ronald Surowitz25
  • Cassandra Steimle26
  • Yaneicy G. Rojas12
  • Antonio Sanchez27
  • Ruth E. Kavcioglu28
  • Julio C. Vijil29
  • Robert Perry30
  • Guy Neff11
  • Martha G. Navarro31
  • Omer Khalid32
  • Rizwana Mohseni33,34
  • Michael A. Zimmerman
  • Julie Vu35
  • Gregg H. Lucksinger36
  • Satish Iduru37
  • Dmitry Shuster38
  • Bruce Segal39
  • Paul Hellstern40
40 affiliations
  1. 1Geisel School of Medicine at Dartmouth, Hanover, NH, USA. [email protected]
  2. 2The Obesity and Metabolism Institute, Boston, MA, USA. [email protected]
  3. 3Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
  4. 4Ulster University, Coleraine, UK
  5. 5University College Dublin School of Medicine, Dublin, Ireland
  6. 6McMaster University, Hamilton, Ontario, Canada
  7. 7University of Toronto, Toronto, Ontario, Canada
  8. 8Winters Center for Heart Failure Research, Cardiovascular Research Institute, Baylor College of Medicine, Houston, TX, USA
  9. 9Boehringer Ingelheim International GmbH, Biberach, Germany
  10. 10Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
  11. 11Covenant Metabolic Specialists, LLC, Sarasota and Fort Myers, FL, USA
  12. 12Optimus U Corp., Miami, FL, USA
  13. 13Stravitz Sanyal Institute for Liver Disease and Metabolic Health, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
  14. 14Velocity Clinical Research, Gardena, CA, USA
  15. 15Clinical Trials of Texas, LLC, San Antonio, dba Flourish Research, San Antonio, TX, USA
  16. 16Washington University School of Medicine, St. Louis, MO, USA
  17. 17Fleming Island Center for Clinical Research, Fleming Island, FL, USA
  18. 18Kansas Medical Clinic, Topeka, KS, USA
  19. 19Excel Medical Clinical Trials, LLC, Boca Raton, dba Flourish Research, Boca Raton, FL, USA
  20. 20Amel Med, LLC, Georgetown, TX, USA
  21. 21Ark Clinical Research – PARENT, Long Beach, CA, USA
  22. 22Louisiana Research Center, LLC, Shreveport, LA, USA
  23. 23Indiana University, Indianapolis, IN, USA
  24. 24Biopharma Informatic, LLC, McAllen, TX, USA
  25. 25Health Awareness, Inc., Jupiter, FL, USA
  26. 26DSI Research Northridge, LLC, Dayton, OH, USA
  27. 27University of Iowa Health Care, Iowa City, IA, USA
  28. 28Velocity Clinical Research, North Hollywood, CA, USA
  29. 29Velocity Clinical Research, Hallandale Beach, FL, USA
  30. 30Panax Clinical Research, LLC, Miami Lakes, FL, USA
  31. 31Ark Clinical Research, Fountain Valley, CA, USA
  32. 32GI Select Health Research, LLC, Richmond, VA, USA
  33. 33Catalina Research Institute, Montclair, CA, USA
  34. 34Velocity Clinical Research, Austin, TX, USA
  35. 35Velocity Clinical Research, Santa Ana, CA, USA
  36. 36Velocity Clinical Research, Waco, TX, USA
  37. 37Accurate Clinical Research, Inc., Richmond, TX, USA
  38. 38Springfield Clinic, Springfield, IL, USA
  39. 39Segal Drug Trials, Delray Beach, FL, USA
  40. 40Nature Coast Clinical Research, Inverness, FL, USA
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Abstract

Survodutide is a glucagon receptor/glucagon-like peptide-1 receptor dual agonist under investigation for treating obesity and related diseases. The SYNCHRONIZE-MASLD phase 3, randomized, double-blind, placebo-controlled trial included 216 adults (131 female and 85 male) with obesity (defined as a body mass index ≥30 kg m − 2 or ≥27 kg m − 2 with at least one obesity complication) and at-risk metabolic dysfunction-associated steatotic liver disease (MASLD), defined by MASLD with evidence of liver inflammation and/or fibrosis by noninvasive tests (NITs) or biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH). Participants were randomized (2:1) and treated with once-weekly subcutaneous injections of survodutide 6.0 mg ( n = 146) or placebo ( n = 70). The co-primary endpoints, ≥30% reduction in magnetic resonance imaging-proton density fat fraction (MRI-PDFF)-assessed liver fat content (LFC) and percentage change in body weight (both baseline to week 48), were met. In total, 84.2% of survodutide-treated patients versus 24.3% of placebo-treated patients had ≥30% reduction in LFC using the efficacy estimand ( P < 0.0001; treatment regimen estimand: 68.5% versus 28.6%, respectively; P < 0.0001). Mean percentage change in body weight was −12.2% with survodutide and −1.0% with placebo using the efficacy estimand ( P < 0.0001; treatment regimen estimand: −8.7% versus −1.4%, respectively; P < 0.0001). The most frequently reported adverse events with survodutide were gastrointestinal, commonly occurring during dose escalation, and were generally of mild-to-moderate severity. In adults with obesity and at-risk MASLD, survodutide treatment was statistically and clinically superior to placebo for reductions in MRI-PDFF-assessed LFC and body weight. Limitations included short trial duration (48 weeks) and limited global reach (participants recruited in the United States and Spain).

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Cite

BibTeXRIS
BibTeX
@article{kaplan2026survodutide,
  title = {{Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial}},
  author = {Lee M. Kaplan and Elena Startseva and Carel Wynand le Roux and Sean Wharton and Biykem Bozkurt and Daniel Ferraz de Campos Mazo and Jessica von Schlippenbach and Sandra González Maldonado and Samina Ajaz Hussain and Guy W. Neff and Yaneicy Gonzalez Rojas and Charles Smith and Ramy Younes and Arun Jayant Sanyal and on behalf of the SYNCHRONIZE-MASLD Investigators and Antonio O. Martin and Juan Manuel Pericàs and Mark Leibowitz and Douglas Scott Denham and Kevin Korenblat and Michael Herman and Shekhar Challa and Rasha Youssef and Masi Khaja and Apinya Vutikullird and Humberto Aguilar and Naga Chalasani and James Maher and Ronald Surowitz and Cassandra Steimle and Yaneicy G. Rojas and Antonio Sanchez and Ruth E. Kavcioglu and Julio C. Vijil and Robert Perry and Guy Neff and Martha G. Navarro and Omer Khalid and Rizwana Mohseni and Michael A. Zimmerman and Julie Vu and Gregg H. Lucksinger and Satish Iduru and Dmitry Shuster and Bruce Segal and Paul Hellstern},
  journal = {Nature Medicine},
  year = {2026},
  month = jun,
  doi = {10.1038/s41591-026-04479-3},
  url = {https://doi.org/10.1038/s41591-026-04479-3},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial
AU  - Lee M. Kaplan
AU  - Elena Startseva
AU  - Carel Wynand le Roux
AU  - Sean Wharton
AU  - Biykem Bozkurt
AU  - Daniel Ferraz de Campos Mazo
AU  - Jessica von Schlippenbach
AU  - Sandra González Maldonado
AU  - Samina Ajaz Hussain
AU  - Guy W. Neff
AU  - Yaneicy Gonzalez Rojas
AU  - Charles Smith
AU  - Ramy Younes
AU  - Arun Jayant Sanyal
AU  - on behalf of the SYNCHRONIZE-MASLD Investigators
AU  - Antonio O. Martin
AU  - Juan Manuel Pericàs
AU  - Mark Leibowitz
AU  - Douglas Scott Denham
AU  - Kevin Korenblat
AU  - Michael Herman
AU  - Shekhar Challa
AU  - Rasha Youssef
AU  - Masi Khaja
AU  - Apinya Vutikullird
AU  - Humberto Aguilar
AU  - Naga Chalasani
AU  - James Maher
AU  - Ronald Surowitz
AU  - Cassandra Steimle
AU  - Yaneicy G. Rojas
AU  - Antonio Sanchez
AU  - Ruth E. Kavcioglu
AU  - Julio C. Vijil
AU  - Robert Perry
AU  - Guy Neff
AU  - Martha G. Navarro
AU  - Omer Khalid
AU  - Rizwana Mohseni
AU  - Michael A. Zimmerman
AU  - Julie Vu
AU  - Gregg H. Lucksinger
AU  - Satish Iduru
AU  - Dmitry Shuster
AU  - Bruce Segal
AU  - Paul Hellstern
PY  - 2026
DA  - 2026/06/07
JO  - Nature Medicine
DO  - 10.1038/s41591-026-04479-3
UR  - https://doi.org/10.1038/s41591-026-04479-3
AB  - Survodutide is a glucagon receptor/glucagon-like peptide-1 receptor dual agonist under investigation for treating obesity and related diseases. The SYNCHRONIZE-MASLD phase 3, randomized, double-blind, placebo-controlled trial included 216 adults (131 female and 85 male) with obesity (defined as a body mass index ≥30 kg m − 2 or ≥27 kg m − 2 with at least one obesity complication) and at-risk metabolic dysfunction-associated steatotic liver disease (MASLD), defined by MASLD with evidence of liver inflammation and/or fibrosis by noninvasive tests (NITs) or biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH). Participants were randomized (2:1) and treated with once-weekly subcutaneous injections of survodutide 6.0 mg ( n = 146) or placebo ( n = 70). The co-primary endpoints, ≥30% reduction in magnetic resonance imaging-proton density fat fraction (MRI-PDFF)-assessed liver fat content (LFC) and percentage change in body weight (both baseline to week 48), were met. In total, 84.2% of survodutide-treated patients versus 24.3% of placebo-treated patients had ≥30% reduction in LFC using the efficacy estimand ( P < 0.0001; treatment regimen estimand: 68.5% versus 28.6%, respectively; P < 0.0001). Mean percentage change in body weight was −12.2% with survodutide and −1.0% with placebo using the efficacy estimand ( P < 0.0001; treatment regimen estimand: −8.7% versus −1.4%, respectively; P < 0.0001). The most frequently reported adverse events with survodutide were gastrointestinal, commonly occurring during dose escalation, and were generally of mild-to-moderate severity. In adults with obesity and at-risk MASLD, survodutide treatment was statistically and clinically superior to placebo for reductions in MRI-PDFF-assessed LFC and body weight. Limitations included short trial duration (48 weeks) and limited global reach (participants recruited in the United States and Spain).
SN  - 1078-8956
SN  - 1546-170X
SN  - 1744-7933
ER  -