NCT03036800|CompletedPhase 4ResultsDMC
Saxenda in Obesity Services (STRIVE Study)
STRIVE
EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study)
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Sponsor study identifier
interventional
392
2 countries
5
Study Start
November 28, 2017
Actual (reported)Primary Completion
February 28, 2021
Actual (reported)Study Completion
February 25, 2022
Actual (reported)A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg \[LIRA 3mg\] with pre-specified stopping rules for the medication). 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 25, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2016
Actual (reported)January 30, 2017
Actual (reported)November 28, 2017
Actual (reported)February 28, 2021
Actual (reported)February 25, 2022
Actual (reported)August 13, 2024
Actual (reported)Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
52 weeks
Weight Loss of ≥15% From Baseline (Intention to Treat)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
52 weeks
Weight Loss of ≥15% From Baseline (Per Protocol)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
52 weeks
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Participant Attendance at Appointments (Intention to Treat)
52 weeks
Participant Attendance at Appointments (Intention to Treat)
104 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
52 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
104 weeks
Participant Compliance With Treatment (Intention to Treat)
52 weeks
Standard care plus targeted use of the intervention Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply
standard Tier 3 obesity specialist service care
standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose)
St Vincent's University Hospital
Dublin, Ireland
NHS Greater Glasgow and Clyde West Glasgow Ambulatory Care Hospital
Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust, Leicester General Hospital
Leicester, United Kingdom
University Hospital Aintree
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Papamargaritis D, Al-Najim W, Lim JZM, Crane J, Bodicoat DH, Barber S, Lean M, McGowan B, O'Shea D, Webb DR, Wilding JPH, le Roux CW, Davies MJ. 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. Lancet Reg Health Eur. 2024 Feb 9;39:100853. doi: 10.1016/j.lanepe.2024.100853. eCollection 2024 Apr.
Papamargaritis D, Al-Najim W, Lim J, Crane J, Lean M, le Roux C, McGowan B, O'Shea D, Webb D, Wilding J, Davies MJ. 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. BMJ Open. 2020 Feb 13;10(2):e034137. doi: 10.1136/bmjopen-2019-034137.
Although the trial was not interrupted during COVID-19 we did issue an USM to the REC \& MHRA during the pandemic to explain that certain aspects of the trial would not be possible, however measures were put in place to ensure participant safety.
Melanie Davies, Prof
Univesrity of Leicester
392 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2016
First Posted
January 30, 2017
Study Start
November 28, 2017
Actual (reported)The Effect of Liraglutide on the GIT
52 weeks
Specialist Obesity Management Services standard of care
Contact the study team to confirm eligibility.
Primary Completion
February 28, 2021
Actual (reported)Study Completion
February 25, 2022
Actual (reported)Last Updated
August 13, 2024
Results First Posted
August 13, 2024
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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