Primary outcomeCount of participants· 52 weeks
Weight Loss of ≥15% From Baseline (Complete Cases)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 51 |
| Standard Care Arm | 6 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataSaxenda in Obesity Services (STRIVE Study)
Short name STRIVE
NCTNCT03036800 (opens ClinicalTrials.gov in a new tab)Other id0626
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 392 participants (actual)
- Sponsor
- University of Leicester · Other
- Design
- Randomized · Open label (no masking)
- Countries
2 countries
Ireland, United Kingdom
- Start
- 28 Nov 2017
- Primary completion
- 28 Feb 2021
- Completion
- 25 Feb 2022
- First posted
- 30 Jan 2017 (estimated)
- Last update posted
- 13 Aug 2024
- Conditions
- Obesity · Weight Loss · Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2017201820192020202120222023
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SaxendaDrug
- Specialist Obesity Management ServicesOther
Arms2
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
Active comparator
Standard Care
standard Tier 3 obesity specialist service care
Primary outcomes4
Outcomes the sponsor listed as primary.
Weight Loss of ≥15% From Baseline (Complete Cases)
Time frame · 52 weeks
Registry description
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.
Weight Loss of ≥15% From Baseline (Intention to Treat)
Time frame · 52 weeks
Registry description
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.
Weight Loss of ≥15% From Baseline (Per Protocol)
Time frame · 52 weeks
Registry description
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.
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)
Time frame · 52 weeks
Registry description
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 outcomes(20)
Participant Attendance at Appointments (Intention to Treat)
Time frame · 52 weeks
Registry description
Attended at least 70% of scheduled Tier 3 appointments by 52 weeks
Participant Attendance at Appointments (Intention to Treat)
Time frame · 104 weeks
Registry description
Attended at least 70% of scheduled Tier 3 appointments by 104 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Time frame · 52 weeks
Registry description
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 52 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Time frame · 104 weeks
Registry description
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 104 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Participant Compliance With Treatment (Intention to Treat)
Time frame · 52 weeks
Registry description
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 52 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Participant Compliance With Treatment (Intention to Treat)
Time frame · 104 weeks
Registry description
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 104 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Patient Stopping of Treatment (Intention to Treat)
Time frame · 16 weeks
Registry description
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 16 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Patient Stopping of Treatment (Intention to Treat)
Time frame · 32 weeks
Registry description
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 32 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Patient Stopping of Treatment (Intention to Treat)
Time frame · 52 weeks
Registry description
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 52 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
Time frame · 52 weeks
Registry description
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 16 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 16 weeks.
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
Time frame · 52 weeks
Registry description
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 32 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 32 weeks.
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)
Time frame · 52 weeks
Registry description
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 52 weeks.
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)
Time frame · 104 weeks
Registry description
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 104 weeks.
Referral to Other Obesity Interventions (Intention to Treat)
Time frame · 104 weeks
Registry description
Number of participants referred to Tier 4 for bariatric surgery over the 104 weeks study period
Referral to Other Obesity Interventions by Site (Intention to Treat)
Time frame · 104 weeks
Registry description
Referrals for bariatric surgery by 104 weeks, stratified by study site.
Bariatric Surgery Completion (Intention to Treat)
Time frame · 104 weeks
Registry description
Number of participants who underwent bariatric surgery by 104 weeks.
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame · 16 weeks
Registry description
Proportion of participants reaching weight loss of ≥5% from baseline, at 16 weeks.
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame · 32 weeks
Registry description
Proportion of participants reaching weight loss of ≥5% from baseline, at 32 weeks.
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame · 52 weeks
Registry description
Proportion of participants reaching weight loss of ≥5% from baseline, at 52 weeks.
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame · 104 weeks
Registry description
Proportion of participants reaching weight loss of ≥5% from baseline, at 104 weeks.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· 52 weeks
Weight Loss of ≥15% From Baseline (Intention to Treat)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 55 |
| Standard Care Arm | 6 |
Primary outcomeCount of participants· 52 weeks
Weight Loss of ≥15% From Baseline (Per Protocol)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 40 |
| Standard Care Arm | 5 |
Primary outcomeCount of participants· 52 weeks
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 40 |
| Standard Care Arm | 5 |
Secondary and other outcome results(4)
Secondary outcomeCount of participants· 52 weeks
Participant Attendance at Appointments (Intention to Treat)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 0 |
| Standard Care Arm | 1 |
Secondary outcomeCount of participants· 104 weeks
Participant Attendance at Appointments (Intention to Treat)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 0 |
| Standard Care Arm | 0 |
Secondary outcomeCount of participants· 52 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 111 |
| Standard Care Arm | NA |
Secondary outcomeCount of participants· 104 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
| Group | Value (Participants) |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | 53 |
| Standard Care Arm | NA |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)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). Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care | 2 / 260 | 43 / 260 | 238 / 260 |
| Standard Care ArmSpecialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care | 0 / 132 | 16 / 132 | 89 / 132 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
0 studies on this page
Indexing hint: Clinical trial · 2020
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.
Papamargaritis et al. 2020BMJ opencited by 8
PMID 32060156PMC7044994DOI 10.1136/bmjopen-2019-034137PUB-32060156
Free to read · publisher termsCC BY-NC
More studies
1 study on this page
PubMed tag: none · 2024
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.
Papamargaritis et al. 2024The Lancet regional health. Europecited by 13
PMID 38803628PMC11129336DOI 10.1016/j.lanepe.2024.100853PUB-38803628
Free to read · publisher termsCC BY-NC-ND
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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