Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial

Abstract

Introduction: In the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.

Methods and analysis: In this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2 plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.

Ethics and dissemination: The Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent's University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.

Trial registration number: ClinicalTrials.gov-Identifier: NCT03036800.European Clinical Trials Database-Identifier: EudraCT Number 2017-002998-20.

Keywords: complex obesity; liraglutide 3 mg; saxenda; specialist weight management services; weight loss.

Conflict of interest statement

Competing interests: DP is funded from an NIHR Clinical Lectureship and reports grants from the Novo Nordisk UK Research Foundation outside submitted work; WA-N is funded by the Irish Research Council’s Postdoctoral Enterprise Partnership Scheme and reports personal fees from Novo Nordisk outside the submitted work; JL has nothing to disclose; JC reports participation at the Novo Nordisk Emerging Obesity Leaders Programme which included registration and travel expenses to the European Congress of Obesity 2019, Glasgow, funded by Novo Nordisk; ML reports grants and personal fees from Novo Nordisk, personal fees from Sanofi, personal fees from Eli Lilly, personal fees from Counterweight, personal fees from Roche, outside the submitted work; ClR reports grants from Science Foundation Ireland, grants from Health Research Board, during the conduct of the study; other from Novo Nordisk, other from GI Dynamics, personal fees from Eli Lilly, grants and personal fees from Johnson and Johnson, personal fees from Sanofi Aventis, personal fees from Astra Zeneca, personal fees from Janssen, personal fees from Bristol-Myers Squibb, personal fees from Boehringer-Ingelheim, outside the submitted work; BM reports grants from Novo Nordisk, during the conduct of the study; grants and personal fees from Novo Nordisk, personal fees from Sanofi, personal fees from Boheringher Ingelheim, personal fees from MSD, outside the submitted work; DO has nothing to disclose; DW has nothing to disclose; JW reports grants from Novo Nordisk, during the conduct of the study; grants, personal fees and other from AstraZeneca, other from Astellas, personal fees and other from Boehringer Ingelheim, other from Janssen, personal fees and other from Mundipharma, personal fees and other from Napp, personal fees and other from Lilly, personal fees and other from Sanofi, other from Wilmington Healthcare, outside the submitted work; MJD reports grants from Novo Nordisk, during the conduct of the study; personal fees from Novo Nordisk, personal fees from Sanofi-Aventis, personal fees from Lilly, personal fees from Merck Sharp & Dohme, personal fees from Boehringer Ingelheim, personal fees from AstraZeneca, personal fees from Janssen, personal fees from Servier, personal fees from Mitsubishi Tanabe Pharma Corporation, personal fees from Takeda Pharmaceuticals International, grants from Sanofi-Aventis, grants from Lilly, grants from Boehringer Ingelheim, grants from Janssen, outside the submitted work.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Study design.

Figure 2

Participant flowchart. LIRA, liraglutide; SWMS, specialist weight management service; WL, weight loss.