STRIVE

CompletedPhase 4Results posted

Saxenda in Obesity Services (STRIVE Study)

EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study)

Lead sponsor

University of Leicester

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

392

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥35

Primary endpoint

•≥15% weight-loss responders

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03036800

Org study ID0626

Timeline

Milestones

Study first posted2017-01-30estimated

Study start2017-11-28actual

Primary completion2021-02-28actual

Study completion2022-02-25actual

Last update posted2024-08-13actual

Results first posted2024-08-13actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (162)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Other clinical outcomes

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Cardiometabolic biomarkers

Weight & body composition

98 endpoints

Primary/registry result

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	51	-
Standard Care Arm	6	-

Odds ratio (or)5.1995% CI2.09 - 12.88p<0.001Regression, Logistic

Primary/registry result

Weight Loss of ≥15% From Baseline (Intention to Treat)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	55	-
Standard Care Arm	6	-

Odds ratio (or)5.9495% CI2.45 - 14.4p<0.001Regression, Logistic

Primary/registry result

Weight Loss of ≥15% From Baseline (Per Protocol)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	40	-
Standard Care Arm	5	-

Odds ratio (or)5.0495% CI1.81 - 14.01p0.002Regression, Logistic

Primary/registry result

Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	40	-
Standard Care Arm	5	-

Odds ratio (or)5.2495% CI1.88 - 14.64p0.002Regression, Logistic

Primary/protocol endpoint

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Primary/protocol endpoint

Weight Loss of ≥15% From Baseline (Intention to Treat)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Primary/protocol endpoint

Weight Loss of ≥15% From Baseline (Per Protocol)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Primary/protocol endpoint

Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:16 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	186	-
Standard Care Arm	34	-

Odds ratio (or)10.1295% CI5.26 - 19.48p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:32 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	158	-
Standard Care Arm	34	-

Odds ratio (or)5.1795% CI2.86 - 9.36p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:52 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	127	-
Standard Care Arm	29	-

Odds ratio (or)4.1695% CI2.39 - 7.22p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:104 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	62	-
Standard Care Arm	17	-

Odds ratio (or)2.4495% CI1.23 - 4.84p0.010Regression, Logistic

Secondary/registry result

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:16 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	60	-
Standard Care Arm	9	-

Odds ratio (or)5.1495% CI2.14 - 12.39p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:32 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	110	-
Standard Care Arm	14	-

Odds ratio (or)6.5395% CI3.32 - 12.86p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:52 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	90	-
Standard Care Arm	9	-

Odds ratio (or)8.0895% CI3.80 - 17.16p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:104 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	32	-
Standard Care Arm	8	-

Odds ratio (or)2.2895% CI0.95 - 5.47p0.065Regression, Logistic

Secondary/registry result

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:16 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	10	-
Standard Care Arm	2	-

Odds ratio (or)2.8495% CI0.56 - 14.34p0.206Regression, Logistic

Secondary/registry result

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:32 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	32	-
Standard Care Arm	5	-

Odds ratio (or)3.2395% CI1.17 - 8.90p0.023Regression, Logistic

Secondary/registry result

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	15	-
Standard Care Arm	2	-

Odds ratio (or)4.1195% CI0.89 - 18.93p0.070Regression, Logistic

Secondary/registry result

Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	12	-
Standard Care Arm	2	-

Odds ratio (or)0.5995% CI0.08 - 4.24p0.601Regression, Logistic

Secondary/registry result

Absolute Weight Change (Complete Cases)

Time frame:16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · kg	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-9.61	-
Standard Care Arm	-5.54	-

Mean difference (net)-4.6395% CI-5.85 - -3.4p<0.001Regression, Linear

Secondary/registry result

Absolute Weight Change (Complete Cases)

Time frame:32 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · kg	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-11.27	-
Standard Care Arm	-5.70	-

Mean difference (net)-5.8995% CI-7.76 - -4.02p<0.001Regression, Linear

Secondary/registry result

Absolute Weight Change (Complete Cases)

Time frame:52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · kg	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-10.15	-
Standard Care Arm	-3.21	-

Mean difference (net)-6.8795% CI-9.03 - -4.71p<0.001Regression, Linear

Secondary/registry result

Absolute Weight Change (Complete Cases)

Time frame:104 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · kg	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-6.51	-
Standard Care Arm	-1.27	-

Mean difference (net)-5.4495% CI-8.34 - -2.53p<0.001Regression, Linear

Secondary/registry result

Percentage Weight Change (Complete Cases)

Time frame:16 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-7.63	-
Standard Care Arm	-4.39	-

Mean difference (net)-3.7295% CI-4.63 - -2.80p<0.001Regression, Linear

Secondary/registry result

Percentage Weight Change (Complete Cases)

Time frame:32 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-9.00	-
Standard Care Arm	-4.58	-

Mean difference (net)-4.7095% CI-6.14 - -3.25p<0.001Regression, Linear

Secondary/registry result

Percentage Weight Change (Complete Cases)

Time frame:52 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-8.13	-
Standard Care Arm	-2.67	-

Mean difference (net)-5.3795% CI-7.02 - -3.71p<0.001Regression, Linear

Secondary/registry result

Percentage Weight Change (Complete Cases)

Time frame:104 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-5.18	-
Standard Care Arm	-1.21	-

Mean difference (net)-4.1095% CI-6.42 - -1.77p0.001Regression, Linear

Secondary/registry result

Absolute BMI Change (Complete Cases)

Time frame:52 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Mean · kg/m2	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-3.84	-
Standard Care Arm	-1.17	-

Mean difference (net)-2.795% CI-3.5 - -1.91p<0.001Regression, Linear

Secondary/registry result

Absolute BMI Change (Complete Cases)

Time frame:104 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Mean · kg/m2	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-2.30	-
Standard Care Arm	-0.49	-

Mean difference (net)-1.8995% CI-2.91 - -0.86p<0.001Regression, Linear

Secondary/registry result

Absolute Waist Circumference Change (Complete Cases)

Time frame:52 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Mean · Centimetres	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-8.88	-
Standard Care Arm	-5.58	-

Mean difference (net)-3.2895% CI-5.77 - -0.80p0.01Regression, Linear

Secondary/registry result

Absolute Waist Circumference Change (Complete Cases)

Time frame:104 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Mean · Centimetres	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-6.42	-
Standard Care Arm	-0.93	-

Mean difference (net)-5.5195% CI-9.09 - -1.94p0.003Regression, Linear

Secondary/registry result

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:16 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	54	-
Standard Care Arm	34	-

Secondary/registry result

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:32 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	53	-
Standard Care Arm	34	-

Secondary/registry result

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:52 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	51	-
Standard Care Arm	29	-

Secondary/registry result

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:104 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	33	-
Standard Care Arm	17	-

Odds ratio (or)10.5395% CI3.83 - 28.97p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:16 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	34	-
Standard Care Arm	9	-

Odds ratio (or)23.195% CI7.55 - 70.67p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:32 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	53	-
Standard Care Arm	14	-

Secondary/registry result

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:52 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	51	-
Standard Care Arm	9	-

Secondary/registry result

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:104 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	23	-
Standard Care Arm	8	-

Odds ratio (or)7.7195% CI2.75 - 21.60p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:16 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	8	-
Standard Care Arm	2	-

Odds ratio (or)6.1495% CI1.16 - 32.32p0.032Regression, Logistic

Secondary/registry result

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:32 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	24	-
Standard Care Arm	5	-

Odds ratio (or)11.4895% CI3.80 - 34.67p<0.001Regression, Logistic

Secondary/registry result

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	51	-
Standard Care Arm	6	-

Secondary/registry result

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	12	-
Standard Care Arm	2	-

Odds ratio (or)13.6395% CI2.47 - 75.09p0.003Regression, Logistic

Secondary/registry result

Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	12	-
Standard Care Arm	2	-

Odds ratio (or)0.5995% CI0.08 - 4.24p0.601Regression, Logistic

Secondary/registry result

Percentage Weight Change (Responder Population)

Time frame:16 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-11.45	-
Standard Care Arm	-4.39	-

Mean difference (net)-6.5595% CI-7.81 - -5.29p<0.001Regression, Linear

Secondary/registry result

Percentage Weight Change (Responder Population)

Time frame:32 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-14.82	-
Standard Care Arm	-4.58	-

Mean difference (net)-9.5995% CI-11.30 - -7.88p<0.001Regression, Linear

Secondary/registry result

Percentage Weight Change (Responder Population)

Time frame:52 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-17.21	-
Standard Care Arm	-2.67	-

Mean difference (net)-13.5195% CI-15.51 - -11.51p<0.001Regression, Linear

Secondary/registry result

Percentage Weight Change (Responder Population)

Time frame:104 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · percentage	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-11.01	-
Standard Care Arm	-1.21	-

Mean difference (net)-9.3095% CI-12.35 - -6.26p<0.001Regression, Linear

Secondary/registry result

Absolute BMI Change (Responder Population)

Time frame:52 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Mean · kg/m2	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-7.65	-
Standard Care Arm	-1.17	-

Mean difference (net)-6.1695% CI-7.03 - -5.28p<0.001Regression, Linear

Secondary/registry result

Absolute BMI Change (Responder Population)

Time frame:104 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Mean · kg/m2	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-4.86	-
Standard Care Arm	-0.49	-

Mean difference (net)-4.2295% CI-5.56 - -2.89p<0.001Regression, Linear

Secondary/registry result

Absolute Waist Circumference Change (Responder Population)

Time frame:52 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Mean · Centimetres	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-15.33	-
Standard Care Arm	-5.58	-

Median difference (net)-8.8095% CI-11.96 - -5.64p<0.001Regression, Linear

Secondary/registry result

Absolute Waist Circumference Change (Responder Population)

Time frame:104 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Mean · Centimetres	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	-10.20	-
Standard Care Arm	-0.93	-

Median difference (net)-9.5995% CI-14.91 - -4.27p0.001Regression, Linear

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:16 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:32 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:52 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Complete Cases)

Time frame:104 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:16 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:32 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:52 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Complete Cases)

Time frame:104 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:16 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:32 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥15% From Baseline (Complete Cases)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute Weight Change (Complete Cases)

Time frame:16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute Weight Change (Complete Cases)

Time frame:32 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute Weight Change (Complete Cases)

Time frame:52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute Weight Change (Complete Cases)

Time frame:104 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage Weight Change (Complete Cases)

Time frame:16 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Weight Change (Complete Cases)

Time frame:32 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Weight Change (Complete Cases)

Time frame:52 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Weight Change (Complete Cases)

Time frame:104 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute BMI Change (Complete Cases)

Time frame:52 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute BMI Change (Complete Cases)

Time frame:104 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute Waist Circumference Change (Complete Cases)

Time frame:52 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute Waist Circumference Change (Complete Cases)

Time frame:104 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:16 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:32 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:52 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥5% From Baseline (Responder Population)

Time frame:104 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:16 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:32 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:52 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥10% From Baseline (Responder Population)

Time frame:104 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:16 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:32 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:52 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight Loss of ≥15% From Baseline (Responder Population)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population)

Time frame:104 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage Weight Change (Responder Population)

Time frame:16 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Weight Change (Responder Population)

Time frame:32 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Weight Change (Responder Population)

Time frame:52 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Weight Change (Responder Population)

Time frame:104 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute BMI Change (Responder Population)

Time frame:52 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute BMI Change (Responder Population)

Time frame:104 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute Waist Circumference Change (Responder Population)

Time frame:52 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute Waist Circumference Change (Responder Population)

Time frame:104 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints

Secondary/registry result/low confidence

Glycaemic Status (Complete Cases)

Time frame:52 weeks

categorical status, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Normoglycaemia at baseline	52	-
Normoglycaemia at follow-up	67	-
Prediabetes at baseline	21	-
Prediabetes at follow-up	10	-
Diabetes remission at baseline	8	-
Diabetes remission at follow-up	0	-
Diabetes at baseline	84	-
Diabetes at follow-up	88	-
Standard Care ArmNormoglycaemia at baseline	24	-
Normoglycaemia at follow-up	24	-
Prediabetes at baseline	9	-
Prediabetes at follow-up	7	-
Diabetes remission at baseline	2	-
Diabetes remission at follow-up	2	-
Diabetes at baseline	21	-
Diabetes at follow-up	23	-

Secondary/registry result/low confidence

Glycaemic Status (Complete Cases)

Time frame:104 weeks

categorical status, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Normoglycaemia at baseline	25	-
Normoglycaemia at follow-up	31	-
Prediabetes at baseline	13	-
Prediabetes at follow-up	8	-
Diabetes remission at baseline	5	-
Diabetes remission at follow-up	0	-
Diabetes at baseline	58	-
Diabetes at follow-up	62	-
Standard Care ArmNormoglycaemia at baseline	19	-
Normoglycaemia at follow-up	15	-
Prediabetes at baseline	7	-
Prediabetes at follow-up	8	-
Diabetes remission at baseline	1	-
Diabetes remission at follow-up	1	-
Diabetes at baseline	19	-
Diabetes at follow-up	22	-

Secondary/registry result

HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)

Time frame:52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	10	-
	44	-
Standard Care Arm	11	-
	6	-

Secondary/registry result

HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)

Time frame:104 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	10	-
	29	-
Standard Care Arm	10	-
	7	-

Secondary/registry result

HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)

Time frame:52 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	17	-
	37	-
Standard Care Arm	14	-
	3	-

Secondary/registry result

HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)

Time frame:104 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	16	-
	23	-
Standard Care Arm	12	-
	5	-

Secondary/protocol endpoint

Glycaemic Status (Complete Cases)

Time frame:52 weeks

categorical status, improvement

Secondary/protocol endpoint

Glycaemic Status (Complete Cases)

Time frame:104 weeks

categorical status, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)

Time frame:52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)

Time frame:104 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)

Time frame:52 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)

Time frame:104 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

4 endpoints

Secondary/registry result

Hypertension (Complete Cases)

Time frame:52 weeks

categorical status, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Hypertension at baseline	37	-
Hypertension at baseline	135	-
Hypertension at follow-up	41	-
Hypertension at follow-up	131	-
Standard Care ArmHypertension at baseline	20	-
Hypertension at baseline	60	-
Hypertension at follow-up	21	-
Hypertension at follow-up	59	-

Secondary/registry result

Hypertension (Complete Cases)

Time frame:104 weeks

categorical status, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Hypertension at baseline	35	-
Hypertension at baseline	92	-
Hypertension at follow-up	38	-
Hypertension at follow-up	89	-
Standard Care ArmHypertension at baseline	16	-
Hypertension at baseline	42	-
Hypertension at follow-up	15	-
Hypertension at follow-up	43	-

Secondary/protocol endpoint

Hypertension (Complete Cases)

Time frame:52 weeks

categorical status, improvement

Secondary/protocol endpoint

Hypertension (Complete Cases)

Time frame:104 weeks

categorical status, improvement

Patient-reported / QoL

5 endpoints

Secondary/registry result

Patient Health Questionnaire-9 (Complete Cases)

Time frame:52 weeks

descriptive, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Minimal depression at baseline	27	-
Minimal depression at follow-up	48	-
Mild depression at baseline	33	-
Mild depression at follow-up	30	-
Moderate depression at baseline	29	-
Moderate depression at follow-up	27	-
Moderately severe depression at baseline	32	-
Moderately severe depression at follow-up	18	-
Severe depression at baseline	18	-
Severe depression at follow-up	16	-
Standard Care ArmMinimal depression at baseline	16	-
Minimal depression at follow-up	24	-
Mild depression at baseline	15	-
Mild depression at follow-up	9	-
Moderate depression at baseline	23	-
Moderate depression at follow-up	14	-
Moderately severe depression at baseline	2	-
Moderately severe depression at follow-up	6	-
Severe depression at baseline	7	-
Severe depression at follow-up	10	-

Secondary/registry result

Patient Health Questionnaire-9 (Complete Cases)

Time frame:104 weeks

descriptive, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Minimal depression at baseline	19	-
Minimal depression at follow-up	32	-
Mild depression at baseline	27	-
Mild depression at follow-up	26	-
Moderate depression at baseline	20	-
Moderate depression at follow-up	21	-
Moderately severe depression at baseline	23	-
Moderately severe depression at follow-up	12	-
Severe depression at baseline	13	-
Severe depression at follow-up	11	-
Standard Care ArmMinimal depression at baseline	15	-
Minimal depression at follow-up	17	-
Mild depression at baseline	10	-
Mild depression at follow-up	16	-
Moderate depression at baseline	18	-
Moderate depression at follow-up	10	-
Moderately severe depression at baseline	3	-
Moderately severe depression at follow-up	4	-
Severe depression at baseline	4	-
Severe depression at follow-up	3	-

Secondary/protocol endpoint

Patient Health Questionnaire-9 (Complete Cases)

Time frame:52 weeks

descriptive, improvement

Secondary/protocol endpoint

Patient Health Questionnaire-9 (Complete Cases)

Time frame:104 weeks

descriptive, improvement

Secondary/protocol endpoint

Epworth Sleepiness Scale (Complete Cases)

Time frame:104 weeks

change from baseline, improvement

Safety / tolerability / PK

16 endpoints

Secondary/registry result

Cessation of Treatment Due to Adverse Effects (Intention to Treat)

Time frame:52 weeks

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	111	-
	3	-
	146	-
	0	-
Standard Care Arm	NA	-
	NA	-
	NA	-
	NA	-

Secondary/registry result

Cessation of Treatment Due to Adverse Effects (Intention to Treat)

Time frame:104 weeks

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	53	-
	2	-
	205	-
	0	-
Standard Care Arm	NA	-
	NA	-
	NA	-
	NA	-

Secondary/registry result

Participant Compliance With Treatment (Intention to Treat)

Time frame:104 weeks

threshold achievement, descriptive

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	27	-
	229	-
	4	-
Standard Care Arm	NA	-
	NA	-
	NA	-

Secondary/registry result

Patient Stopping of Treatment (Intention to Treat)

Time frame:16 weeks

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	181	-
	79	-
	0	-
Standard Care Arm	NA	-
	NA	-
	NA	-

Secondary/registry result

Patient Stopping of Treatment (Intention to Treat)

Time frame:32 weeks

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	110	-
	71	-
	0	-
Standard Care Arm	NA	-
	NA	-
	NA	-

Secondary/registry result

Patient Stopping of Treatment (Intention to Treat)

Time frame:52 weeks

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	53	-
	57	-
	0	-
Standard Care Arm	NA	-
	NA	-
	NA	-

Secondary/protocol endpoint

Participant Attendance at Appointments (Intention to Treat)

Time frame:104 weeks

threshold achievement, descriptive

Secondary/protocol endpoint

Cessation of Treatment Due to Adverse Effects (Intention to Treat)

Time frame:52 weeks

Discontinuation due to AE

threshold achievement, event

Secondary/protocol endpoint

Cessation of Treatment Due to Adverse Effects (Intention to Treat)

Time frame:104 weeks

Discontinuation due to AE

threshold achievement, event

Secondary/protocol endpoint

Participant Compliance With Treatment (Intention to Treat)

Time frame:52 weeks

categorical status, descriptive

Secondary/protocol endpoint

Participant Compliance With Treatment (Intention to Treat)

Time frame:104 weeks

categorical status, descriptive

Secondary/protocol endpoint

Patient Stopping of Treatment (Intention to Treat)

Time frame:16 weeks

Discontinuation due to AE

categorical status, event

Secondary/protocol endpoint

Patient Stopping of Treatment (Intention to Treat)

Time frame:32 weeks

Discontinuation due to AE

categorical status, event

Secondary/protocol endpoint

Patient Stopping of Treatment (Intention to Treat)

Time frame:52 weeks

Discontinuation due to AE

categorical status, event

Secondary/protocol endpoint

Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)

Time frame:52 weeks

categorical status, descriptive

Secondary/protocol endpoint

Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)

Time frame:104 weeks

categorical status, descriptive

Other clinical outcomes

27 endpoints

Secondary/registry result

Participant Attendance at Appointments (Intention to Treat)

Time frame:52 weeks

descriptive

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	0	-
	115	-
	60	-
	85	-
Standard Care Arm	1	-
	51	-
	43	-
	37	-

Secondary/registry result

Participant Attendance at Appointments (Intention to Treat)

Time frame:104 weeks

descriptive

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	0	-
	92	-
	117	-
	51	-
Standard Care Arm	0	-
	46	-
	66	-
	20	-

Secondary/registry result

Participant Compliance With Treatment (Intention to Treat)

Time frame:52 weeks

threshold achievement, descriptive

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	23	-
	233	-
	4	-
Standard Care Arm	NA	-
	NA	-
	NA	-

Secondary/registry result/low confidence

Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)

Time frame:52 weeks

threshold achievement, descriptive

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	60	-
	19	-
	181	-
	0	-
Standard Care Arm	NA	-
	NA	-
	NA	-
	NA	-

Secondary/registry result

Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)

Time frame:52 weeks

threshold achievement, descriptive

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	49	-
	22	-
	110	-
	0	-
Standard Care Arm	NA	-
	NA	-
	NA	-
	NA	-

Secondary/registry result

Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)

Time frame:52 weeks

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	203	-
	3	-
	54	-
Standard Care Arm	92	-
	1	-
	39	-

Secondary/registry result

Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)

Time frame:104 weeks

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	144	-
	3	-
	113	-
Standard Care Arm	64	-
	2	-
	66	-

Secondary/registry result

Referral to Other Obesity Interventions (Intention to Treat)

Time frame:104 weeks

event count, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	125	-
	25	-
	110	-
Standard Care Arm	64	-
	5	-
	63	-

Secondary/registry result

Referral to Other Obesity Interventions by Site (Intention to Treat)

Time frame:104 weeks

event count, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	3	-
	0	-
	10	-
	2	-
	10	-
	235	-
Standard Care Arm	3	-
	0	-
	0	-
	1	-
	1	-
	127	-

Secondary/registry result

Bariatric Surgery Completion (Intention to Treat)

Time frame:104 weeks

threshold achievement, event

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)	142	-
	6	-
	112	-
Standard Care Arm	64	-
	4	-
	64	-

Secondary/registry result

Kings College Obesity Staging (KCOS) Score (Complete Cases)

Time frame:52 weeks

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Normal health at baseline	0	-
Normal health at follow-up	1	-
At risk of disease at baseline	6	-
At risk of disease at follow-up	23	-
Established disease at baseline	97	-
Established disease at follow-up	108	-
Advanced disease at baseline	42	-
Advanced disease at follow-up	13	-
Standard Care ArmNormal health at baseline	0	-
Normal health at follow-up	0	-
At risk of disease at baseline	5	-
At risk of disease at follow-up	12	-
Established disease at baseline	41	-
Established disease at follow-up	43	-
Advanced disease at baseline	17	-
Advanced disease at follow-up	8	-

Secondary/registry result

Kings College Obesity Staging (KCOS) Score (Complete Cases)

Time frame:104 weeks

descriptive

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)Normal health at baseline	0	-
Normal health at follow-up	2	-
At risk of disease at baseline	5	-
At risk of disease at follow-up	16	-
Established disease at baseline	84	-
Established disease at follow-up	86	-
Advanced disease at baseline	26	-
Advanced disease at follow-up	11	-
Standard Care ArmNormal health at baseline	0	-
Normal health at follow-up	0	-
At risk of disease at baseline	4	-
At risk of disease at follow-up	10	-
Established disease at baseline	37	-
Established disease at follow-up	35	-
Advanced disease at baseline	10	-
Advanced disease at follow-up	6	-

Secondary/registry result

Epworth Sleepiness Scale (Complete Cases)

Time frame:52 weeks

descriptive, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)No obstructive sleep apnoea at baseline	111	-
No obstructive sleep apnoea at follow-up	119	-
Possible obstructive sleep apnoea at baseline	34	-
Possible obstructive sleep apnoea at follow-up	26	-
Standard Care ArmNo obstructive sleep apnoea at baseline	47	-
No obstructive sleep apnoea at follow-up	50	-
Possible obstructive sleep apnoea at baseline	15	-
Possible obstructive sleep apnoea at follow-up	12	-

Secondary/registry result

Epworth Sleepiness Scale (Complete Cases)

Time frame:104 weeks

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)No obstructive sleep apnoea at baseline	85	-
No obstructive sleep apnoea at follow-up	90	-
Possible obstructive sleep apnoea at baseline	25	-
Possible obstructive sleep apnoea at follow-up	20	-
Standard Care ArmNo obstructive sleep apnoea at baseline	38	-
No obstructive sleep apnoea at follow-up	44	-
Possible obstructive sleep apnoea at baseline	17	-
Possible obstructive sleep apnoea at follow-up	11	-

Secondary/registry result

Stop Bang Questionnaire (Complete Cases)

Time frame:52 weeks

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)No obstructive sleep apnoea at baseline	10	-
No obstructive sleep apnoea at follow-up	18	-
Possible obstructive sleep apnoea at baseline	34	-
Possible obstructive sleep apnoea at follow-up	43	-
Likely obstructive sleep apnoea at baseline	49	-
Likely obstructive sleep apnoea at follow-up	32	-
Standard Care ArmNo obstructive sleep apnoea at baseline	4	-
No obstructive sleep apnoea at follow-up	10	-
Possible obstructive sleep apnoea at baseline	12	-
Possible obstructive sleep apnoea at follow-up	14	-
Likely obstructive sleep apnoea at baseline	28	-
Likely obstructive sleep apnoea at follow-up	20	-

Secondary/registry result

Stop Bang Questionnaire (Complete Cases)

Time frame:104 weeks

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)No obstructive sleep apnoea at baseline	11	-
No obstructive sleep apnoea at follow-up	12	-
Possible obstructive sleep apnoea at baseline	26	-
Possible obstructive sleep apnoea at follow-up	38	-
Likely obstructive sleep apnoea at baseline	47	-
Likely obstructive sleep apnoea at follow-up	34	-
Standard Care ArmNo obstructive sleep apnoea at baseline	3	-
No obstructive sleep apnoea at follow-up	4	-
Possible obstructive sleep apnoea at baseline	13	-
Possible obstructive sleep apnoea at follow-up	13	-
Likely obstructive sleep apnoea at baseline	24	-
Likely obstructive sleep apnoea at follow-up	23	-

Secondary/protocol endpoint

Participant Attendance at Appointments (Intention to Treat)

Time frame:52 weeks

threshold achievement, descriptive

Secondary/protocol endpoint

Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)

Time frame:52 weeks

categorical status, descriptive

Secondary/protocol endpoint

Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)

Time frame:52 weeks

categorical status, descriptive

Secondary/protocol endpoint

Referral to Other Obesity Interventions (Intention to Treat)

Time frame:104 weeks

event count, event

Secondary/protocol endpoint

Referral to Other Obesity Interventions by Site (Intention to Treat)

Time frame:104 weeks

event count, event

Secondary/protocol endpoint

Bariatric Surgery Completion (Intention to Treat)

Time frame:104 weeks

event count, event

Secondary/protocol endpoint

Kings College Obesity Staging (KCOS) Score (Complete Cases)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Kings College Obesity Staging (KCOS) Score (Complete Cases)

Time frame:104 weeks

change from baseline, improvement

Secondary/protocol endpoint

Epworth Sleepiness Scale (Complete Cases)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Stop Bang Questionnaire (Complete Cases)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Stop Bang Questionnaire (Complete Cases)

Time frame:104 weeks

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
The Lancet regional health. Europe2024 Apr (month)PMID38803628doi:10.1016/j.lanepe.2024.100853via clinicaltrials gov reference derived + pubmed nct search
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 open2020 Feb 13PMID32060156doi:10.1136/bmjopen-2019-034137via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.