STRIVE

STRIVE (Effectiveness and cost of integrating a protocol with use of Liraglutide 3.0mg into an obesity service)

Study name

Background

Severe and complicated obesity (defined as a BMI ≥35kg/m2 with at least one obesity-related comorbidity) is a substantial health problem. Standard care for patients with severe and complicated obesity is variable, but includes referral to a ‘Tier 3’ or specialist weight management service. The Tier 3 service offers a combination of diet and lifestyle advice, meal replacements, and pharmacological therapies to facilitate weight loss. According to guidelines, individuals with severe and complicated obesity qualify for bariatric surgery; however, the majority of patients prefer not to have surgery. Liraglutide 3.0mg, as evidenced from large randomised controlled trials, has demonstrated that it is a safe and effective treatment option for obesity.

Study Aims

The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.

Study Summary

The study is a parallel, two-group, open-label, real-world randomised controlled trial. Participants were recruited into one of two arms over a 26-month period; recruitment is now closed. The two arms are 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg with pre-specified stopping rules for the medication). The total duration of participation is 104 weeks; the first 52 weeks of the study (after randomisation) will determine whether using the targeted prescribing pathway in a Tier 3 setting will result in more participants attaining ≥15% weight loss compared with standard care. The second 52 weeks of the study will assess whether patients who lose ≥15% of their baseline weight by the first 52 weeks are more likely to maintain ≥15% weight loss for another 52 weeks in the targeted prescribing pathway compared with standard care.

Study Progress 

The study opened to recruitment in November 2017 with five sites participating (Leicester, Liverpool, London, Dublin and Glasgow). Our recruitment target of 392 across the five sites was met in February 2020 and recruitment was closed. The study is now in a 2-year follow-up period, which will end in February 2022. The participants continue to attend the sites for their follow up appointments, safety reviews and data collection.

Funding and Sponsorship 

The study is funded by Novo Nordisk, a leading global healthcare company, founded in 1923 and headquartered in Denmark. The study is sponsored by University of Leicester Research Governance Office Sponsor.

Study Publications

Dr Papamargaritis submitted a publication to the British Medical Journal in 2020: https://bmjopen.bmj.com/content/10/2/e034137

Research Team

Chief Investigator: Prof Melanie Davies

Principal Investigator Leicester: Dr David Webb

Principal Investigator Liverpool: Prof John Wilding

Principal Investigator London: Dr Barbara McGowan

Principal Investigator Dublin: Prof Carel Le Roux

Principal Investigator Glasgow: Prof Mike Lean

Project Manager all sites: Sarah Clarke

For more information, please contact: STRIVE@uhl-tr.nhs.uk