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Saxenda in Obesity Services (STRIVE Study) (STRIVE)

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ClinicalTrials.gov Identifier: NCT03036800
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : June 18, 2018
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 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 : September 2020
Estimated Study Completion Date : January 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 LIRA 3mg according to the outlined protocol in combination with standard care 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 ]
    budget impact of a Tier 3 weight management service

  2. cost-effectiveness [ Time Frame: 52 & 104 weeks ]
    long-term cost-effectiveness when used as part of the proposed combination strategy

  3. improving obesity-related co-morbidities [ Time Frame: 52 & 104 weeks ]
    improving obesity-related co-morbidities (obstructive sleep apnoea , prediabetes, diabetes, hypertension)

  4. Maintenance of ≥15% weight loss until 104 weeks (an additional 52 weeks) [ Time Frame: 104 weeks ]
    proportion of patients who will achieve ≥15% weight loss at 52 weeks after randomisation and will be able to maintain ≥15% weight loss for another 52 weeks

  5. patient compliance [ Time Frame: 16, 32, 52 and 104 weeks ]
  6. referral rates to other obesity interventions [ Time Frame: 52 and 104 weeks ]

Other Outcome Measures:
  1. Liver function tests [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: Alkaline Transaminase (i u/L), Alkaline Phosphatase (i u/L), Total Bilirubin (umol/L), Albumin (g/L)

  2. Thyroid function tests [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: Thyroid Stimulating Hormone (miu/L), Free Thyroxine (pmol/L)

  3. Renal function tests [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: Urea (mmol/L), Creatinine (umol/L), eGFR (mL/min)

  4. Haematology profile [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: White Blood Cell Count (x10^9/L), Red blood cell count (x10^12/L), Haemoglobin (g/L), Haematocrit (L/L), Mean Cell Volume (fL), Mean Cell Haemoglobin (pg), Platelet Count (x10^9/L)

  5. Lipids [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: Cholesterol (mmol/L), Triglycerides (mmol/L), HDL Cholesterol (mmol/L), LDL Cholesterol calc (mmol/L), HDL Ratio

  6. HbA1c [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: DCCT (%), IFCC (mmol/mol)

  7. Amylase [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: (U/L)

  8. Lipase [ Time Frame: Screening, 32, 52 and 104 weeks ]
    Biochemistry: (U/L)

  9. Height [ Time Frame: Screening-104 weeks ]
    Anthropometric Measures: (cm)

  10. Weight [ Time Frame: Screening-104 weeks ]
    Anthropometric Measures: (kg)

  11. BMI [ Time Frame: Screening-104 weeks ]
    Anthropometric Measures: (kg/m2)

  12. Waist Circumference [ Time Frame: Screening-104 weeks ]
    Anthropometric Measures: (cm)

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

  14. Scoring System [ Time Frame: Screening, 52 and 104 weeks ]
    Epworth score

  15. Scoring System [ Time Frame: Screening, 52 and 104 weeks ]
    Apnoea Hypopnoea Index

  16. Scoring System [ Time Frame: Screening, 52 and 104 weeks ]
    Oxygen Desaturation Index

  17. Scoring System [ Time Frame: Screening, 52 and 104 weeks ]
    CPAP Pressures

  18. Medical History [ Time Frame: Screening - 104 weeks ]
    including surgical history

  19. Demographics [ Time Frame: Screening - 104 weeks ]
  20. Concomitant medication [ Time Frame: Screening - 104 weeks ]
  21. HSRUQ (Health service and resource uses questionnaire) [ Time Frame: Baseline, 52 and 104 weeks ]
    Questionnaire

  22. TSQM (Treatment Satisfaction Questionnaire for Medication) [ Time Frame: Baseline, 52 and 104 weeks ]
    Questionnaire

  23. EQ5D-5L (Quality of Life) [ Time Frame: Baseline, 52 and 104 weeks ]
    Questionnaire

  24. IWQOL-Lite (Impact of Weight on Quality of Life) [ Time Frame: Baseline, 52 and 104 weeks ]
    Questionnaire

  25. Change in concomitant medications [ Time Frame: Baseline-104 weeks ]
  26. Blood Pressure [ Time Frame: Screening-104 weeks ]
    mmHg

  27. Pulse Rate [ Time Frame: Screening-104 weeks ]
    PBM

  28. Adverse Events [ Time Frame: Baseline - 104 weeks ]
    including Serious Adverse Events

  29. Adherence with injections [ Time Frame: Baseline-104 weeks ]
    LIRA 3mg arm only

  30. Adherence with other anti-obesity medications [ Time Frame: Baseline - 104 weeks ]
  31. Adherence to Tier 3 (or equivalent) Service [ Time Frame: Baseline - 104 weeks ]


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)
  • 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. 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 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
  • Treatment with GLP-1 receptor agonists at the past
  • 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
  • Have terminal illness
  • Are not primarily responsible for their own care
  • Not willing or able to give informed consent
  • Unable to understand English
  • 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 or lipase 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
  • Any lifetime history of a suicidal attempt
  • A history of any suicidal behaviour in the last month prior to randomization.
  • Any suicidal ideation of type 4 or 5 on the Columbian Suicidality Severity Rating Scale (C-SSRS) in the last month prior to randomization

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
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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

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03036800     History of Changes
Other Study ID Numbers: U1111-1189-5726
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
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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Diabetes Mellitus
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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