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

IntroductionIn 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 analysisIn 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/m2plus 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 disseminationThe 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 numberClinicalTrials.gov—Identifier:NCT03036800.European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.

Liraglutide 3.0 mg in the treatment of adults with obesity and prediabetes using real‐world UK data: A clinical evaluation of a multi‐ethnic population

“…33 It is yet to report and is assessing 2 years of liraglutide 3.0 mg in patients with obesity and related complications. 38 We demonstrate that nearly all responders reversed prediabetes to normoglycaemia, and the median HbA1c reduction was Data shows a reversal of prediabetes to normo-glycaemic reduces long-term T2D risk by 56% and the risk of incident microvascular and macrovascular complications. [40][41][42][43][44] Further evaluation of the long-term cardiometabolic health benefit associated with GLP-1 agonist therapy is warranted in patients with obesity and prediabetes.…”

“…Alongside our data, The STRIVE study, which is a phase 4 trial of liraglutide within UK tier 3 weight management services, will provide further clarification. It is yet to report and is assessing 2 years of liraglutide 3.0 mg in patients with obesity and related complications 38 …”

GLP-1 receptor agonists, SGLT-2 inhibitors, and obstructive sleep apnoea: can new allies face an old enemy?

“…Three efficacy targets and prespecified stopping rules, when these targets are not achieved, will be evaluated [73]. The primary objective will be to compare the proportion of individuals achieving weight loss ≥ 15% at 52 weeks between the 2 arms.…”

“…The primary objective is to determine whether LIRA administration can be beneficial in this population, either as monotherapy or combined with CPAP. The primary outcome measure is the change in AHI from baseline values Papamargaritis et al [73] 2020…”

Liraglutide (Saxenda®) for the treatment of obesity: a commentary on NICE Technology Appraisal 664

“…10,11 Clinical trials are also ongoing to examine the practicality and cost effectiveness of using expensive medical weight loss therapies in real-life settings. 12 In summary, the approval of Saxenda ® by NICE opens a new and exciting chapter in obesity management in the NHS. However, restricting its use to Tier 3 services without investment and expansion of these services will be a block that will limit patients' access to a potentially effective treatment, and will add further pressure on already stretched Tier 3 services.…”