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. 2024 Feb 9:39:100853.
doi: 10.1016/j.lanepe.2024.100853. eCollection 2024 Apr.

Effectiveness of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in weight management services (STRIVE study): a multicentre, open-label, parallel-group, randomized controlled trial

Dimitris Papamargaritis  1   2   3 , Werd Al-Najim  4 , Jonathan Z M Lim  5   6 , James Crane  7 , Danielle H Bodicoat  8 , Shaun Barber  9 , Michael Lean  10 , Barbara McGowan  7 , Donal O'Shea  11 , David R Webb  1   2 , John P H Wilding  5 , Carel W le Roux  4 , Melanie J Davies  1   2
Affiliations

Effectiveness of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in weight management services (STRIVE study): a multicentre, open-label, parallel-group, randomized controlled trial

Dimitris Papamargaritis et al. Lancet Reg Health Eur. .

Abstract

Background: An effective prescribing pathway for liraglutide 3 mg, an approved obesity pharmacotherapy, may improve treatment access. This trial compared a targeted prescribing pathway for liraglutide 3 mg with multiple stopping rules in specialist weight management services (SWMS) to standard SWMS care.

Methods: This phase four, two-year, multicentre, open-label, parallel-group, real-world randomized clinical trial (ClinicalTrials.gov: NCT03036800) enrolled adults with BMI ≥35 kg/m2 plus prediabetes, type 2 diabetes, hypertension or sleep apnoea from five SWMS in Ireland and UK. Participants were randomly allocated (2:1, stratified by centre and BMI) to SWMS care plus a targeted prescribing pathway for once daily subcutaneous liraglutide 3 mg (intervention) with stopping rules at 16 (≥5% weight loss, WL), 32 (≥10% WL) and 52 weeks (≥15% WL) or to SWMS care alone (control) through an online randomization service. The primary outcome was WL ≥15% at 52 weeks, assessed by complete cases analysis. All randomized participants were included in safety analysis.

Findings: From November 28, 2017 to February 28, 2020, 434 participants were screened, and 392 randomized (260 intervention; 132 control), while 294 (201 intervention; 93 control) included in the 52 weeks complete case analysis. More intervention than control participants achieved WL ≥15% at 52 weeks [51/201 (25.4%) vs 6/93 (6.5%); odds ratio 5.18; 95% CI 2.09, 12.88; p < 0.0001]. More adverse events occurred in the intervention (238/260, 91.5%; two deaths) than control (89/132, 67.4%; no deaths) group.

Interpretation: A targeted prescribing pathway for liraglutide 3 mg helps more people achieve ≥15% WL at 52 weeks than standard care alone.

Funding: Novo Nordisk A/S.

Keywords: Liraglutide 3 mg; Multiple stopping rules; Obesity; Specialist weight management services; Targeted prescribing pathway.

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Conflict of interest statement

DP has received honoraria and support for attending meetings and/or travel from Novo Nordisk and reports grants from Novo Nordisk, Novo Nordisk UK Research Foundation, Academy of Medical Sciences/Diabetes UK and Health Education East Midlands. DP is also a Trustee for the Association of the Study of Obesity (ASO) and a member of the academic subcommittee of the Association of the British Clinical Diabetologists (ABCD). WAN does not report conflict of interest. JZML does not report conflict of interest. JC reports educational grants from Novo Nordisk. DHB is an independent consultant who is contracted to work on projects, including those in relation to obesity and diabetes. SB does not report conflict of interest. ML reports grants from Novo Nordisk, National Institute for Health Care and Research (NIHR), All Saints Educational Trust and Diabetes UK. ML also reports honoraria from Novo Nordisk, Eli Lilly and Nestle, consulting fees from Counterweight Ltd and has received support for attending meetings and/or travel by EASD nutritional study group. BMG is a shareholder of Reset Health and reports honoraria from Novo Nordisk and Janssen and she has received support for attending meeting or travel by Novo Nordisk. BMG reports also grant from Novo Nordisk and consulting fees from Novo Nordisk, Prizer and Johnson and Johnson. BMG is the Chair of Obesity Management Collaborative- UK and co-chair of the EASO Task Force. DOS does not report conflict of interest. DRW reports research funding support from Novo Nordisk and National Institute for Health Care and Research (NIHR). DRW is also chairing the data and safety monitoring committee for an investigator initiated study funded by Novo Nordisk. JPHW reports consultancy/advisory board work contracted via the University of Liverpool (no personal payment) for Altimmune, AstraZeneca, Boehringer Ingelheim, Lilly, Cytoki, Napp, Novo Nordisk, Menarini, Mundipharma, Pfizer, Rhythm Pharmaceuticals, Sanofi, Saniona, Tern, Shionogi & Ysopia in relation to obesity and type 2 diabetes. JPHW is named grantholder (at University of Liverpool) for research grants for clinical trials from AstraZeneca and Novo Nordisk and has received fees for clinical trials (at Liverpool University Hospitals NHS Foundation Trust) by Novo Nordisk, Lilly and Rhythm Pharmaceuticals. JPHW reports personal lecture fees from AstraZeneca, Boehringer Ingelheim, Napp, Medscape and Novo Nordisk in relation to lectures about diabetes and/or obesity and has received support for attending meeting or travel by Novo Nordisk. JPHW reports editorial work for Springer Nature (Medicine Matters Diabetes website) and he is past president of the World Obesity Federation, and a board member of the World Obesity Federation. JPHW reports also fees (paid to University of Liverpool) from AstraZeneca for being a Data and Safety Monitoring Board member for a clinical trial and he is also the speciality lead for the Metabolic and Endocrine Speciality Group of the NIHR Clinical Research Network, a member of the Rank Prize Funds Nutrition Committee, a previous member of the RCP committee on Nutrition, Weight and Health and an advisor on obesity treatments for NICE. CWlR reports grants from the Irish Research Council, Science Foundation Ireland, Anabio, and the Health Research Board. He serves on the advisory boards of Novo Nordisk, Herbalife, GI Dynamics, Eli Lilly, Johnson & Johnson, Altimmune, Irish Life Health and Boehringer Ingelheim and reports honoraria for presentations from Novo Nordisk, Herbalife, Johnson and Johnson, Eli Lilly, Boehringer Ingelheim, Rhythm Pharmaceuticals and Currax Pharmaceuticals. CWlR has received support to attend meetings and/or travel from Novo Nordisk, Herbalife, Johnson and Johnson, Eli Lilly and Boehringer Ingelheim. CWlR is a member of the Irish Society for Nutrition and Metabolism outside the area of work commented on here. He was the previous chief medical officer and director of the Medical Device Division of Keyron in 2021. Both of these were unremunerated positions. CWlR was a previous investor in Keyron, which develops endoscopically implantable medical devices intended to mimic the surgical procedures of sleeve gastrectomy and gastric bypass. The product has only been tested in rodents and none of Keyron’s products are currently licensed. They do not have any contracts with other companies to put their products into clinical practice. No patients have been included in any of Keyron’s studies and they are not listed on the stock market. CWlR was gifted stock holdings in September, 2021 and divested all stock holdings in Keyron in September, 2021. He continues to provide scientific advice to Keyron for no remuneration. CWlR provides also service to Beyond BMI, a private obesity clinic providing obesity care. MJD has received grants in support of investigator and investigator initiated trials from Novo Nordisk, Sanofi Aventis, Eli Lilly, Boehringer Ingelheim, Astrazeneca and Janssen. MJD reports consulting fees from Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Sanofi, and honoraria for lectures from Eli Lilly, Sanofi Aventis, Boehringer Ingelheim, Novo Nordisk, AstraZeneca, Novartis, Napp Pharmaceuticals and Amgen. Moreover, MJD is an advisory board member for Novo Nordisk, Sanofi Aventis, Eli Lilly, Boehringer Ingelheim, Lexicon, Pfizer, Medtronic, Zealnd Pharma, AstraZeneca and ShouTi Pharma Inc.

Figures

Fig. 1
Fig. 1
Trial profile.
Fig. 2
Fig. 2
Trial design and proportion of participantswho passed eachstopping ruleat the intervention group.
Fig. 3
Fig. 3
Weight loss outcomes. Data shown for complete cases population, OR = odds ratio, ∗∗p = 0.01, ∗∗∗p < 0.0001. (a) The proportion of participants in the control and intervention group who lost at least 5%, 10%, and 15% of their baseline bodyweight at week 52, (b) The proportion of participants in the control and intervention group who lost at least 5%, 10%, and 15% of their baseline bodyweight at week 104 (c) Mean relative change in bodyweight for the complete case population in the control and the intervention group. Data shown are the observed means with standard error of the mean (SEM).
Fig. 4
Fig. 4
“Responders” population and body weight. Data shown is the complete case analysis for the “responders” population, OR = odds ratio, ∗∗p = 0.003, ∗∗∗p < 0.0001. (a) The proportion of participants in the control group and the “responders” group who lost at least 5%, 10%, and 15% of their baseline bodyweight at week 104. (b) Mean relative change in bodyweight for the complete case population at the control group and the “responders” group. Data shown are the observed means with standard error of the mean (SEM).
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