Saxenda in Obesity Services (STRIVE Study)

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

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.