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Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet
  1. Simon Birk Kjær Jensen1,2,
  2. Julie Rehné Lundgren1,2,
  3. Charlotte Janus1,2,
  4. Christian Rimer Juhl1,2,
  5. Lisa Møller Olsen1,2,
  6. Mads Rosenkilde1,2,
  7. Jens Juul Holst1,2,
  8. Bente Merete Stallknecht1,
  9. Sten Madsbad3,
  10. Signe Sørensen Torekov1,2
  1. 1 Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark
  2. 2 Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark
  3. 3 Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
  1. Correspondence to Dr Signe Sørensen Torekov; torekov{at}sund.ku.dk

Abstract

Introduction The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.

Methods and analysis This is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18–65 years) with obesity (body mass index 32–43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.

Ethics and dissemination The trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

Trial registration number 2015-005585-32

  • weight loss
  • weight loss maintenance
  • liraglutide
  • exercise
  • obesity
  • GLP-1 receptor agonist

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Footnotes

  • SBKJ, JRL and CJ contributed equally.

  • Contributors SST formulated, initiated and designed the study. BMS, JJH, SM, MR, CJ and JRL contributed to the overall study design. SST, SBKJ, JRL, CJ, CRJ and LMO contributed to detailed description of interventions, assessments and/or data analysis plan. SBKJ, JRL, CJ and SST drafted the manuscript. All authors have contributed to and approved the final version of the manuscript. Authorship eligibility will follow the Vancouver guidelines.

  • Funding This work is supported by an excellence grant from the Novo Nordisk Foundation (NNF16OC0019968), a Novo Nordisk Foundation Center for Basic Metabolic Research synergy grant and a grant from Helsefonden. The GLP-1 RA (liraglutide 3.0 mg) and placebo are provided by Novo Nordisk. Cambridge weight plan diet products for the initial 8 weeks weight loss programme are provided by Cambridge weight plan. JRL is funded by a PhD grant from Faculty of Health and Medical Sciences, University of Copenhagen. CJ is funded by a PhD grant from Danish Diabetes Academy.

  • Disclaimer The planning and conduct of the study, interpretation of data, and writing of manuscripts are completely independent of the funders.

  • Competing interests SST has received research grants from Novo Nordisk. SM has received research grants from Novo Nordisk and Boehringer Ingelheim; lecture fees from AstraZeneca, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk and Sanofi Aventis; and is a member of advisory boards of AstraZeneca, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, Intarcia Therapeutics, Johnson & Johnson, Merck Sharp & Dohme, Novartis, Novo Nordisk and Sanofi Aventis. JJH has served on advisory panels for GlaxoSmithKline, Novo Nordisk, Zealand Pharma, AstraZeneca, MSD, Intarcia and Hanmi and as a consultant for Novo Nordisk, and has received research support from Merck, Sharp & Dohme.

  • Patient consent for publication Not required.

  • Ethics approval The trial is approved by the Ethical Committee of the Capital Region of Denmark (H-16027082) and the Danish Medicines Agency (EudraCT Number: 2015-005585-32).

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  • Provenance and peer review Not commissioned; externally peer reviewed.

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