Saxenda in Obesity Services (STRIVE Study)

NCT03036800 | Completed Phase 4 Results DMC

• 1 other identifier: 0626
• Study Type: interventional
• Target: 392
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Obesity; Weight Loss; Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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.

  52 weeks

Secondary Outcomes (77)

• 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

Study Arms (2)

Targeted Prescribing Pathway (LIRA 3mg + Standard Care)

EXPERIMENTAL

Standard care plus targeted use of the intervention Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply

Drug: Saxenda; Other: Specialist Obesity Management Services

Standard Care

ACTIVE COMPARATOR

standard Tier 3 obesity specialist service care

Other: Specialist Obesity Management Services

Interventions

Saxenda DRUG

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)

Also known as: Liraglutide 3mg

Targeted Prescribing Pathway (LIRA 3mg + Standard Care)

Specialist Obesity Management Services OTHER

Specialist Obesity Management Services standard of care

Standard Care; Targeted Prescribing Pathway (LIRA 3mg + Standard Care)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be aged between 18-75 years old (inclusive)
• understand written and spoken English
• be able to give in informed consent
• a body mass index ≥35 kg/m2,
• have been referred to Tier 3 weight management or equivalent service in one of the five participating sites,
• have a stable body weight (less than 5kg self-reported change during the previous 12 weeks),
• prediabetes (defined as established diagnosis of impaired fasting glycaemia (IFG) from GP and/or established diagnosis of impaired glucose tolerance (IGT) from GP and/or HbA1C 42-47 mmol/mol (6-6.4%) without glucose lowering medications, at a blood test during the last 6 months) and/or
• type 2 diabetes \[defined as established diagnosis of Type II diabetes from GP and/or HbA1C ≥48 mmol/mol (\>6.5%) at a blood test during the last 6 months\] being treated with any combination of lifestyle, metformin, sulphonylureas, thiazolidinediones (TZDs) or SGLT-2, and/or
• hypertension treated (defined as being on antihypertensive treatment with or without a diagnosis of hypertension from GP) or untreated (defined as Systolic Blood Pressure (SBP) ≥140 mmHg at two consecutive visits at the Tier 3 clinic), and/or
• obstructive sleep apnoea (on CPAP or established diagnosis of Apnoea Hypopnoea Index ≥15 at sleep studies during the last 12 months)

You may not qualify if:

• Diagnosis of Type 1 diabetes
• Type 2 diabetes with treatment on DPP-IV or insulin currently
• Treatment with GLP-1 receptor agonists within the last 6 months and/or have a history of GLP-1 receptor agonist intolerance.
• Treatment with anti-obesity drugs within the last 12 weeks prior to randomisation
• eGFR ≤30ml/min/1.73m2 on serum testing over the last 26 weeks
• Females referred to the clinic because of fertility problem
• Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods during the study period
• Have terminal illness
• Are not primarily responsible for their own care
• Not willing or able to give informed consent
• Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant's ability to participate
• Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid- stimulating hormone \>6 mIU/liter or \<0.4 mIU/liter
• Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
• Personal history of non-familial medullary thyroid carcinoma
• History of chronic pancreatitis or idiopathic acute pancreatitis

Sponsors & Collaborators

• University of Leicester: lead
• Novo Nordisk A/S: collaborator

Study Sites (5)

St Vincent's University Hospital

Dublin, Ireland

Location

NHS Greater Glasgow and Clyde West Glasgow Ambulatory Care Hospital

Glasgow, United Kingdom

Location

University Hospitals of Leicester NHS Trust, Leicester General Hospital

Leicester, United Kingdom

Location

University Hospital Aintree

Liverpool, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38803628 DERIVED

• 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.

  PMID: 32060156 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof Melanie Davies
• Organization: University of Leicester

melanie.davies@uhl-tr.nhs.uk

0116 258 6481

Study Officials

• Melanie Davies, Prof

  Univesrity of Leicester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 30, 2017
• Study Start: November 28, 2017
• Primary Completion: February 28, 2021
• Study Completion: February 25, 2022
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); GB (4)