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Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial
  1. Fabienne Baur1,2,
  2. Cihan Atila1,2,
  3. Sophia Lengsfeld1,2,
  4. Thilo Burkard3,
  5. Andrea Meienberg3,
  6. Cemile Bathelt1,2,
  7. Mirjam Christ-Crain1,2 and
  8. Bettina Winzeler1,2
  1. 1Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland
  2. 2Department of Clinical Research, University of Basel, Basel, Switzerland
  3. 3Medical Outpatient Department, University Hospital Basel, Basel, Switzerland
  1. Correspondence to Dr Bettina Winzeler; bettina.winzeler{at}


Background Women seem to have more difficulty quitting smoking than men. This is particularly concerning as smoking puts women at a higher risk of developing smoking-associated diseases. Greater concerns about postcessation weight gain in women have been postulated as a possible explanation.

Methods Predefined secondary analysis of a placebo-controlled, double-blind, parallel-group, superiority randomised trial including 255 adults who smoke daily (155 women, 100 men). Participants received weekly dulaglutide (1.5 mg) or placebo (0.9% sodium chloride) in addition to standardised smoking cessation care (varenicline 2 mg/day plus behavioural counselling) over 12 weeks. We aimed to investigate gender differences in weight change after dulaglutide-assisted smoking cessation. Weight change between baseline and week 12 was analysed as absolute and revative weight change and as substantial weight gain (defined as >6% increase).

Results No gender differences were observed in absolute or relative weight change neither on dulaglutide nor placebo treatment. However, substantial weight gain (defined as >6% increase) in the placebo group was almost five times more frequent in females than males (24% vs 5%). Female patients were less likely to have substantial weight gain on dulaglutide compared with placebo (1% (n=1/83) vs 24% (n=17/72); p<0.001), while this dulaglutide effect was less pronounced in males (0% (n=0/44) vs 5% (n=3/56); p=0.333).

Conclusion Dulaglutide reduced postcessation weight gain in both genders and was very effective in preventing substantial weight gain, which seems to be a specific observation in females.

Trial registration number NCT03204396.

  • Weight management
  • Metabolic syndrome

Data availability statement

Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Data availability statement

Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request.

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  • FB and CA contributed equally.

  • Presented at This work has previously been presented as a poster at the Endocrine Society’s Annual Meeting (ENDO) 2023 and at the European Congress of Endocrinology (ECE) 2023.

  • Contributors FB: investigation, data curation, formal analysis, writing–original draft preparation (lead). CA: formal analysis (lead), visualisation, writing–original draft preparation. SL: investigation, conceptualisation, writing–review and editing. TB and AM: conceptualisation, writing–review and editing. CB: investigation, project administration. MC-C: conceptualisation, supervision, writing–review and editing. BW: conceptualisation, formal analysis, methodology, funding acquisition, project administration, supervision, writing–review and editing. FB, CA and BW are responsible for the overall content as guarantors. All authors edited and approved the final manuscript.

  • Funding Swiss National Foundation (PZ00P3_193206), G&J Bangerter-Rhyner Foundation, Goldschmidt-Jacobson Foundation, Hemmi Foundation, Swiss Academy of Medical Sciences and funds of the University of Basel and University Hospital Basel.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed by Tera Fazzino, UK of Great Britain and Northern Ireland, and by Jose Seijas-Amigo, Complexo Hospitalario Universitario de Santiago de Compostela, Spain.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.