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
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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/m 2 ) 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
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The trial design has been published previously, and the protocol, with the statistical analysis plan, is available at NEJM.org.
“The trial design has been published previously, 26 and the protocol, with the statistical analysis plan, is available at NEJM.org.”
From Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined (2021) · cites this paper as [26]
The study protocol and primary trial report (including reported harms) have been published.
“The study protocol25 and primary trial report (including reported harms)7 have been published.”
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Self-citationJensen, S. B. K., Sørensen, V., Sandsdal, R. M., Lehmann, E. W., Lundgren, J. R., Juhl, C. R., Janus, C., Ternhamar, T., Stallknecht, B. M., Holst, J. J., et al. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2024.16775 · Cited by 155 · see citing works
Self-citationJensen, S. B. K., Janus, C., Lundgren, J. R., Juhl, C. R., Sandsdal, R. M., Olsen, L. M., Andresen, A., Borg, S. A., Jacobsen, I. C., Finlayson, G., et al. (2022) · Nature Communications · doi:10.1038/s41467-022-32307-y · Cited by 42 · see citing works
Self-citationJensen, S. B. K., Fiorenza, M., Juhl, C. R., Sandsdal, R. M., Jensen, E., Seier, S. S., Janus, C., Jørgensen, J. R., Blond, M. B., Holst, J. J., et al. (2026) · Sports Medicine · doi:10.1007/s40279-025-02386-0 · Cited by 9 · see citing works
“The trial design is detailed in the primary trial report [29] and protocol [30].”
Self-citation
- Authors
- Jensen, S. B. K., Lundgren, J. R., Janus, C., Juhl, C. R., Olsen, L. M., Rosenkilde, M., Holst, J. J., Stallknecht, B. M., Madsbad, S., & Torekov, S. S.
- Affiliations
- University of Copenhagen (DK)
- Hvidovre Hospital (DK)
- Corresponding author
- Torekov, Signe Sørensen
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2019-11
- Volume
- 9
- Issue
- 11
- Pages
- e031431
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6830609
- OpenAlex
- W2989396475
- Cited by
- 20
- References
- 80
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 4 · 2023: 5 · 2022: 4 · 2021: 3
- FWCI
- 1.08
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
- HighWire Press Open Archive (acceptedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (acceptedVersion, cc-by-nc)
- Funders
- Det Sundhedsvidenskabelige Fakultet, Københavns Universitet
- Helsefonden
- Danish Diabetes Academy
- Novo Nordisk Foundation (NNF16OC0019968)
- NNF Center for Basic Metabolic Research
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- liraglutide, GLP-1 receptor agonists, physical activity, weight loss maintenance, very low calorie diet, obesity, combination therapy, body weight
- MeSH terms
- Liraglutide, Adolescent, Adult, Aged, Denmark, Female, Humans, Male, Middle Aged, Obesity, Weight Loss, Exercise, Randomized Controlled Trials as Topic, Caloric Restriction, Incretins
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