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203,234 studies31 sourcesUpdated 14 min ago
Peer-reviewedCC BYNature Medicine

Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial

  • Chloe Stanley1,2
  • Ritwika Mallik3,1,4,2
  • Nausheen Hamid5,1,2
  • Friedrich C. Jassil5,1,6,7,2
  • Victoria Reuven1,2
  • Tapiwa Ruwona1,2
  • Samuel James Dicken8,1,2
  • Sulmaaz Qamar1,2
  • Benjamin Charles Norton1,9,2
  • Helen Kingett10
  • Andrea B. F. Pucci5,1,2
  • Cormac G. Magee1,2
11 more authors
  • David R Boniface1
  • Rachel Louise Batterham5,1
  • Kalpana Devalia11
  • Jessica Mok1,11
  • Mohamed Elkalaawy5
  • JOHN LOY12
  • Andrew D. Jenkinson5
  • Haris Charalampos Markakis5
  • Marco Adamo5
  • Alanna Kathleen Brown1,2
  • Janine Makaronidis13,14,15,16,17
17 affiliations
  1. 1Centre for Obesity Research, University College London, London, UK
  2. 2National Institute for Health Research (NIHR) University College London Hospital Biomedical Research Centre, London, UK
  3. 3Blizard Institute, Queen Mary University of London, London, UK
  4. 4Department of Diabetes and Metabolism, Barts Health NHS Trust, London, UK
  5. 5Bariatric Centre for Weight Management and Metabolic Surgery, University College London Hospital (UCLH), London, UK
  6. 6Department of Endocrinology, Diabetology, and Metabolism, Geneva University Hospitals, Geneva, Switzerland
  7. 7Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
  8. 8Behavioural Science and Health, University College London, London, UK
  9. 9Digestive Disease & Surgery Institute, Cleveland Clinic London, London, UK
  10. 10Ashford and St Peter's Hospitals NHS Foundation Trust, Surrey, UK
  11. 11Homerton University Hospitals, London, UK
  12. 12Auralia Clinic, Dublin, Ireland
  13. 13Blizard Institute, Queen Mary University of London, London, UK. [email protected]
  14. 14Centre for Obesity Research, University College London, London, UK. [email protected]
  15. 15Department of Diabetes and Metabolism, Barts Health NHS Trust, London, UK. [email protected]
  16. 16Homerton University Hospitals, London, UK. [email protected]
  17. 17National Institute for Health Research (NIHR) University College London Hospital Biomedical Research Centre, London, UK. [email protected]
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Abstract

A suboptimal clinical response after metabolic and bariatric surgery (MBS) is common and carries considerable health concerns. Here a double-blinded, randomized (1:1), placebo-controlled trial using semaglutide 2.4 mg weekly (BARI-STEP) recruited adult participants at least 1 year after gastric bypass or sleeve gastrectomy with a suboptimal clinical response, defined as less than 20% weight loss from surgery. This was an adjunct to lifestyle intervention with a 500-kcal daily energy deficit. The primary outcome was percentage weight loss after 68-week treatment on an intention-to-treat analysis. Seventy participants (mean (s.d.) age = 47.3 (10.3) years, 58 (82.9%) female and 12 (17.1%) male) were randomized to receive 2.4 mg semaglutide (n = 35) or placebo (n = 35). The intention-to-treat sample included 63 participants. Estimated change in mean (s.d.) percentage weight loss from baseline to week 68 was -18.0 (9.2) with semaglutide 2.4 mg (n = 34) versus +0.4 (7.0) with placebo (n = 29). The mean adjusted treatment difference in percentage body weight change for semaglutide 2.4 mg versus placebo was -19.18 (95% confidence interval -23.4 to -14.8; P < 0.001). Adverse events (AEs) were consistent with the known safety and tolerability profile of semaglutide, with no new safety concerns for the post-bariatric population. There were eight serious AEs, one suspected unexpected serious adverse reaction and no treatment-related deaths. BARI-STEP demonstrates that in people with a suboptimal clinical response after MBS, semaglutide results in substantial and clinically significant body weight reduction along with improvement in metabolic parameters and quality of life, compared to placebo. These findings suggest that semaglutide 2.4 mg is a safe and effective treatment option for this patient population. ClinicalTrials.gov: NCT05073835 .

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Cite

BibTeXRIS
BibTeX
@article{stanley2026semaglutide,
  title = {{Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial}},
  author = {Chloe Stanley and Ritwika Mallik and Nausheen Hamid and Friedrich C. Jassil and Victoria Reuven and Tapiwa Ruwona and Samuel James Dicken and Sulmaaz Qamar and Benjamin Charles Norton and Helen Kingett and Andrea B. F. Pucci and Cormac G. Magee and David R Boniface and Rachel Louise Batterham and Kalpana Devalia and Jessica Mok and Mohamed Elkalaawy and JOHN LOY and Andrew D. Jenkinson and Haris Charalampos Markakis and Marco Adamo and Alanna Kathleen Brown and Janine Makaronidis},
  journal = {Nature Medicine},
  year = {2026},
  month = may,
  doi = {10.1038/s41591-026-04416-4},
  url = {https://doi.org/10.1038/s41591-026-04416-4},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial
AU  - Chloe Stanley
AU  - Ritwika Mallik
AU  - Nausheen Hamid
AU  - Friedrich C. Jassil
AU  - Victoria Reuven
AU  - Tapiwa Ruwona
AU  - Samuel James Dicken
AU  - Sulmaaz Qamar
AU  - Benjamin Charles Norton
AU  - Helen Kingett
AU  - Andrea B. F. Pucci
AU  - Cormac G. Magee
AU  - David R Boniface
AU  - Rachel Louise Batterham
AU  - Kalpana Devalia
AU  - Jessica Mok
AU  - Mohamed Elkalaawy
AU  - JOHN LOY
AU  - Andrew D. Jenkinson
AU  - Haris Charalampos Markakis
AU  - Marco Adamo
AU  - Alanna Kathleen Brown
AU  - Janine Makaronidis
PY  - 2026
DA  - 2026/05/22
JO  - Nature Medicine
DO  - 10.1038/s41591-026-04416-4
UR  - https://doi.org/10.1038/s41591-026-04416-4
AB  - A suboptimal clinical response after metabolic and bariatric surgery (MBS) is common and carries considerable health concerns. Here a double-blinded, randomized (1:1), placebo-controlled trial using semaglutide 2.4 mg weekly (BARI-STEP) recruited adult participants at least 1 year after gastric bypass or sleeve gastrectomy with a suboptimal clinical response, defined as less than 20% weight loss from surgery. This was an adjunct to lifestyle intervention with a 500-kcal daily energy deficit. The primary outcome was percentage weight loss after 68-week treatment on an intention-to-treat analysis. Seventy participants (mean (s.d.) age = 47.3 (10.3) years, 58 (82.9%) female and 12 (17.1%) male) were randomized to receive 2.4 mg semaglutide (n = 35) or placebo (n = 35). The intention-to-treat sample included 63 participants. Estimated change in mean (s.d.) percentage weight loss from baseline to week 68 was -18.0 (9.2) with semaglutide 2.4 mg (n = 34) versus +0.4 (7.0) with placebo (n = 29). The mean adjusted treatment difference in percentage body weight change for semaglutide 2.4 mg versus placebo was -19.18 (95% confidence interval -23.4 to -14.8; P < 0.001). Adverse events (AEs) were consistent with the known safety and tolerability profile of semaglutide, with no new safety concerns for the post-bariatric population. There were eight serious AEs, one suspected unexpected serious adverse reaction and no treatment-related deaths. BARI-STEP demonstrates that in people with a suboptimal clinical response after MBS, semaglutide results in substantial and clinically significant body weight reduction along with improvement in metabolic parameters and quality of life, compared to placebo. These findings suggest that semaglutide 2.4 mg is a safe and effective treatment option for this patient population. ClinicalTrials.gov: NCT05073835 .
SN  - 1078-8956
SN  - 1546-170X
SN  - 1744-7933
ER  -