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Saxenda in Obesity Services (STRIVE Study) (STRIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036800
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Leicester

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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Diabetes Mellitus Drug: Saxenda Other: Specialist Obesity Management Services Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study)
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
Standard care plus targeted use of the intervention Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply
Drug: Saxenda
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)
Other Name: Liraglutide 3mg

Other: Specialist Obesity Management Services
Specialist Obesity Management Services standard of care

Active Comparator: Standard Care
standard Tier 3 obesity specialist service care
Other: Specialist Obesity Management Services
Specialist Obesity Management Services standard of care




Primary Outcome Measures :
  1. Weight loss of ≥15% at 52 weeks [ Time Frame: 52 weeks ]
    The primary outcome of the study will be the 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.


Secondary Outcome Measures :
  1. Budget impact of a Tier 3 weight management service [ Time Frame: 52 & 104 weeks ]
    1. Cost of the proposed LIRA 3mg (as per protocol - e.g. actual dose taken = number of days taking study drug x daily cost of drug, or cost of total amount of study drug used)
    2. Cost of visits to clinician for assessment and medication prescription during Specialist Weight Management Service programme
    3. Cost of visits to dietician during Specialist Weight Management Service programme
    4. Cost of visits to psychologist during Specialist Weight Management Service programme
    5. Cost of physical activity physiologist/physiotherapist during Specialist Weight Management Service programme (if applicable)
    6. Cost of Multidisciplinary Team (MDT) discussion in Specialist Weight Management Service
    7. Cost of blood tests in Specialist Weight Management Service
    8. Cost of consumables and goods
    9. Cost of referral into Tier 4

  2. Estimated long-term cost-effectiveness [ Time Frame: 104 weeks ]
    1. Length of treatment with LIRA 3mg
    2. Daily dose of LIRA 3mg (based on actual doses taken)

  3. Improving obesity-related comorbidities [ Time Frame: 52 & 104 weeks ]
    This will be assessed by the Kings College Obesity Staging (KCOS) score. The score is 0-3.

  4. Maintenance of ≥15% weight loss until 104 weeks (an additional 52 weeks) [ Time Frame: 104 weeks ]
    Proportion of participants maintaining weight loss of ≥15% among those who lost ≥15% at 52 weeks

  5. Patient adherence to treatment [ Time Frame: 16, 32, 52 and 104 weeks ]
    Study drug reconciliation

  6. Referral rates to other obesity interventions [ Time Frame: 52 and 104 weeks ]
    Number of participants referred to Tier 4 for bariatric surgery over the 104 weeks study period

  7. Safety related outcomes [ Time Frame: 52 and 104 weeks ]
    AE reporting

  8. Patient satisfaction [ Time Frame: 52 and 104 weeks ]
    Treatment Satisfaction Questionnaire for Medication (TSQM)

  9. Patient quality of life [ Time Frame: 52 and 104 weeks ]
    EuroQol five dimension scale (EQ5D) the minimum value is 0 and maximum is 100, low scores are a worse outcome and high scores are a better outcome.


Other Outcome Measures:
  1. Weight (kg) [ Time Frame: 16, 32, 52 and 104 weeks ]
    Absolute change in weight from baseline Anthropometric measures: (Kg)

  2. Relative change in weight from baseline [ Time Frame: 16, 32, 52 and 104 weeks ]
    (% change in weight)

  3. Physical Activity [ Time Frame: 52 and 104 weeks ]
    International physical activity questionnaire (IPAQ- Long Form) there is not a scale, this is based on hours and minutes of physical activity. A higher number is a better outcome and a lower number is a worse outcome.

  4. Change in concomitant medications [ Time Frame: Screening - 104 weeks ]
    Concomitant medication reporting

  5. Medical History (including surgical history) [ Time Frame: 52 and 104 weeks ]
    Patient notes

  6. HSRUQ (Health service and resource uses questionnaire) [ Time Frame: Screening, 52 and 104 weeks ]
    Questionnaire

  7. Length of treatment with LIRA 3mg [ Time Frame: 52 and 104 weeks ]
    Days of treatment with LIRA 3mg

  8. Daily dose of LIRA 3mg (based on actual doses taken) [ Time Frame: 52 and 104 weeks ]
    Mg of liraglutide actually taken

  9. HbA1C [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: IFCC (mmol/mol)

  10. Proportion of participants with normoglycaemia (defined as HbA1C <42.0 mmol/mol without glucose lowering medications) [ Time Frame: Screening, 52 and 104 weeks ]
    % percentage of the population in each group having normoglycaemia

  11. Proportion of participants with prediabetes (defined as HbA1C 42.0-47.9 mmol/mol without glucose lowering medications) [ Time Frame: Screening, 52 and 104 weeks ]
    % percentage of the population in each group having prediabetes

  12. Proportion of participants with diabetes (defined as HbA1C ≥48 mmol/mol or on glucose lowering medications) [ Time Frame: Screening, 52 and 104 weeks ]
    % percentage of the population in each group having type 2 diabetes

  13. Number of medications for management of type 2 diabetes [ Time Frame: Screening, 52 and 104 weeks ]
    Number

  14. Dose of medications for management of type 2 diabetes [ Time Frame: Screening, 52 and 104 weeks ]
    Medications for type 2 diabetes dose

  15. Class of medications for type 2 diabetes [ Time Frame: Screening, 52 and 104 weeks ]
    Medication class for type 2 diabetes

  16. Monitoring of Albumin- Creatinine Ratio (ACR) for patients with prediabetes, diabetes and hypertension. [ Time Frame: Screening, 32, 52 and 104 weeks ]
    (mg/mmol)

  17. Blood pressure [ Time Frame: Screening - 104 weeks ]
    (mmHg)

  18. Proportion of participants with hypertension (defined as patients on antihypertensive medications or systolic blood pressure>140mmHg) [ Time Frame: Screening, 52 and 104 weeks ]
    % percentage of the population in each group having hypertension

  19. Dose of antihypertensive medication [ Time Frame: Screening, 52 and 104 weeks ]
    Dose of medications for treatment of hypertension

  20. Class of antihypertensive medications [ Time Frame: Screening, 52 and 104 weeks ]
    Medication class for treatment of hypertension

  21. Number of anti-hypertensive medication [ Time Frame: Screening, 52 and 104 weeks ]
    Number

  22. Epworth score [ Time Frame: Screening, 52 and 104 weeks ]
    Questionnaire

  23. Stop Bang questionnaire [ Time Frame: Screening, 52 and 104 weeks ]
    Questionnaire

  24. Proportion of participants on CPAP [ Time Frame: Screening, 52 and 104 weeks ]
    % percentage of the population in each group on CPAP

  25. CPAP pressures for patients on variable pressures CPAP [ Time Frame: screening, 52 and 104 weeks ]
    Centimeters of water pressure (cm H20)

  26. Apnoea Hypopnea Index (AHI) for participants with sleep apnoea who cannot tolerate CPAP or for participants on fixed pressures CPAP [ Time Frame: Screening, 52 and 104 weeks ]
    Apnoea Hypopnea Index

  27. Oxygen desaturation index for participants with sleep apnoea who cannot tolerate CPAP or for participants on fixed pressures CPAP [ Time Frame: Screening, 52 and 104 weeks ]
    Oxygen desaturation Index

  28. Lipids [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: Cholesterol (mmol/l), triglycerides (mmol/l), HDL cholesterol (mmol/l), LDL cholesterol (mmol/l), HDL ratio

  29. Dose of medication for dyslipidaemia [ Time Frame: Screening, 52 and 104 weeks ]
    Dose of medications for treatment of dyslipidaemia

  30. Class of medications for dyslipidaemia [ Time Frame: Screening, 52 and 104 weeks ]
    Medication class for treatment of dyslipidaemia

  31. Number of medications for dyslipidaemia [ Time Frame: Screening, 52 and 104 weeks ]
    Number

  32. King's College Obesity Staging System assessment [ Time Frame: Screening, 52 and 104 weeks ]
    Scoring System

  33. The number of participants who did or did not attend at least 70% of the scheduled appointments with the Specialist Weight Management Service (completers) [ Time Frame: 52 and 104 weeks ]
    Number

  34. The number of participants who had to stop treatment with LIRA 3mg because of adverse effects (targeted prescribing pathway only) [ Time Frame: 52 and 104 weeks ]
    Number

  35. The number of participants who stopped LIRA 3mg at 16 weeks after randomization [ Time Frame: 16 weeks ]
    Number

  36. The number of participants who stopped LIRA 3mg at 32 weeks after randomization [ Time Frame: 32 weeks ]
    Number

  37. The number of participants who stopped LIRA 3mg at 52 weeks after randomization [ Time Frame: 52 weeks ]
    Number

  38. The number of participants who completed 52 weeks of the Specialist Weight Management Service programme despite stopping LIRA 3mg at 16 weeks [ Time Frame: 52 weeks ]
    % percentage

  39. The number of participants who completed 52 weeks of the Specialist Weight Management Service programme despite stopping LIRA 3mg at 32 weeks [ Time Frame: 52 weeks ]
    % percentage

  40. The adherence of participants with LIRA 3mg (monitored through return of used pens and questionnaires) - Targeted prescribing pathway only [ Time Frame: 16, 32, 52 and 104 weeks ]
    % percentage

  41. The number of participants started on anti-obesity drugs [ Time Frame: 16, 32, 52 and 104 weeks ]
    Number

  42. The adherence of participants with other anti-obesity medications [ Time Frame: 16, 32, 52 and 104 weeks ]
    % percentage

  43. Gastrointestinal symptoms [ Time Frame: Baseline, 52 and 104 weeks ]
    Total number of gastrointestinal symptoms in each group

  44. Overall hypoglycaemia rate [ Time Frame: Baseline, 52 and 104 weeks ]
    % of patients who experience a hypoglycaemic event in each group

  45. Overall AE/SAE rate [ Time Frame: Baseline, 52 and 104 weeks ]
    Total number of AE/SAE in each group

  46. Rates of severe hypoglycaemia [ Time Frame: Baseline, 52 and 104 weeks ]
    % of patients who experience severe hypoglycaemia in each group

  47. Heart rate [ Time Frame: Baseline - 104 weeks ]
    Pulse/min

  48. Impact of Weight on Quality of Life-Lite (IWQOL-Lite) [ Time Frame: Baseline, 52 and 104 weeks ]
    The minimum value is 1 and maximum value is 5. A higher number is a worse outcome and a lower number is a better outcome.

  49. Patient Health Questionnaire-9 (PHQ9) [ Time Frame: Baseline, 52 and 104 weeks ]
    The minimum value is 0 and maximum value is 3. A higher number is a worse outcome and a lower number is a better outcome.

  50. Proportion of participants reaching weight loss of ≥5%, ≥10% and ≥15% [ Time Frame: 16, 32, 52 (except of ≥15% weight loss which is primary outcome) and 104 weeks ]
    (% percentage)

  51. BMI and change in BMI from baseline [ Time Frame: 16, 32, 52 and 104 weeks ]
    (kg/m2)

  52. Waist circumference [ Time Frame: 52 and 104 weeks ]
    (cm)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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),
  • Participant must be able to meet at least one of the inclusion criteria listed below:

    1. 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
    2. 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
    3. 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
    4. obstructive sleep apnoea (on CPAP or established diagnosis of Apnoea Hypopnoea Index ≥15 at sleep studies during the last 12 months)

Exclusion Criteria:

  • 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
  • Amylase levels three times higher than the upper normal range
  • Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
  • Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7−10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium)
  • History of major depressive episode during the last 2 years
  • History of initiation of antidepressants during the last 12 weeks
  • Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions.
  • Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)
  • History of other severe psychiatric disorders
  • History of known or suspected abuse of alcohol and/or narcotics
  • History of major depressive episode during the last 2 years
  • Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036800


Contacts
Layout table for location contacts
Contact: Melanie Davies, Prof 0116258 ext 6481 melanie.davies@uhl-tr.nhs.uk
Contact: Emer Brady, Dr 0116258 ext 8959 emer.brady@uhl-tr.nhs.uk

Locations
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Ireland
St Vincent's University Hospital Recruiting
Dublin, Ireland
Contact: Carel Le Roux, Prof    0171 66 831    carel.leroux@ucd.ie   
Principal Investigator: Carel LeRoux, Prof         
Sub-Investigator: Donel O'Shea, Prof         
United Kingdom
NHS Greater Glasgow and Clyde West Glasgow Ambulatory Care Hospital Not yet recruiting
Glasgow, United Kingdom
Contact: Mike Lean, Prof    0141 201 8604    mike.lean@glasgow.ac.uk   
University Hospitals of Leicester NHS Trust, Leicester General Hospital Recruiting
Leicester, United Kingdom
Contact: Melanie Davies, Prof    0116 258 6481    melanie.davies@uhl-tr.nhs.uk   
Sub-Investigator: David Webb, Dr         
University Hospital Aintree Recruiting
Liverpool, United Kingdom
Contact: John Wilding, Prof    0151 529 5899    J.P.H.Wilding@liverpool.ac.uk   
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Barbara McGowan, Dr    020 7188 1912    barbara.mcGowan@gstt.nhs.uk   
Sponsors and Collaborators
University of Leicester
Novo Nordisk A/S
Investigators
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Principal Investigator: Melanie Davies, Prof Univesrity of Leicester

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03036800    
Other Study ID Numbers: 0626
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists