Trial Outcomes & Findings for Saxenda in Obesity Services (STRIVE Study) (NCT NCT03036800)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

392 participants

Primary outcome timeframe

52 weeks

Results posted on

2024-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	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	Standard Care Arm Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
Overall Study STARTED	260	132
Overall Study Week 16	252	117
Overall Study Week 32	243	113
Overall Study Week 52	237	110
Overall Study Week 104	215	104
Overall Study COMPLETED	201	93
Overall Study NOT COMPLETED	59	39

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Standard Care Arm Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
Overall Study Protocol Violation	1	0
Overall Study Non-compliance	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Death	1	0
Overall Study Tolerance	5	0
Overall Study Unknown/no reason given	50	39

Baseline Characteristics

Saxenda in Obesity Services (STRIVE Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Total n=392 Participants Total of all reporting groups
Glycaemic Status Missing	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	228 Participants n=5 Participants	113 Participants n=7 Participants	341 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	19 Participants n=7 Participants	51 Participants n=5 Participants
Age, Continuous	51.10 years STANDARD_DEVIATION 10.81 • n=5 Participants	51.81 years STANDARD_DEVIATION 10.77 • n=7 Participants	51.34 years STANDARD_DEVIATION 10.79 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	79 Participants n=7 Participants	252 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	53 Participants n=7 Participants	140 Participants n=5 Participants
Race/Ethnicity, Customized White	225 Participants n=5 Participants	114 Participants n=7 Participants	339 Participants n=5 Participants
Race/Ethnicity, Customized Black	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Mixed/Other	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Weight	129.02 Kg STANDARD_DEVIATION 25.33 • n=5 Participants	127.09 Kg STANDARD_DEVIATION 21.42 • n=7 Participants	128.37 Kg STANDARD_DEVIATION 24.08 • n=5 Participants
BMI	46.22 Kg/m2 STANDARD_DEVIATION 7.75 • n=5 Participants	45.52 Kg/m2 STANDARD_DEVIATION 7.25 • n=7 Participants	45.99 Kg/m2 STANDARD_DEVIATION 7.58 • n=5 Participants
Heart Rate	78.27 Beats/minute STANDARD_DEVIATION 11.21 • n=5 Participants	78.37 Beats/minute STANDARD_DEVIATION 12.24 • n=7 Participants	78.30 Beats/minute STANDARD_DEVIATION 11.55 • n=5 Participants
Waist Circumference	132.44 Centimetre STANDARD_DEVIATION 15.56 • n=5 Participants	131.81 Centimetre STANDARD_DEVIATION 12.95 • n=7 Participants	132.23 Centimetre STANDARD_DEVIATION 14.73 • n=5 Participants
HbA1c mmol/mol	46.10 Mmol/mol STANDARD_DEVIATION 13.72 • n=5 Participants	44.71 Mmol/mol STANDARD_DEVIATION 10.79 • n=7 Participants	45.64 Mmol/mol STANDARD_DEVIATION 12.82 • n=5 Participants
HbA1c %	6.36 % STANDARD_DEVIATION 1.27 • n=5 Participants	6.24 % STANDARD_DEVIATION 0.99 • n=7 Participants	6.32 % STANDARD_DEVIATION 1.18 • n=5 Participants
Systolic Blood Pressure	135.77 mmHg STANDARD_DEVIATION 18.26 • n=5 Participants	138.12 mmHg STANDARD_DEVIATION 17.79 • n=7 Participants	136.56 mmHg STANDARD_DEVIATION 18.12 • n=5 Participants
Diastolic Blood Pressure	81.35 mmHg STANDARD_DEVIATION 10.94 • n=5 Participants	81.99 mmHg STANDARD_DEVIATION 12.04 • n=7 Participants	81.57 mmHg STANDARD_DEVIATION 11.31 • n=5 Participants
LDL Cholesterol	2.71 mmol/L STANDARD_DEVIATION 0.84 • n=5 Participants	2.70 mmol/L STANDARD_DEVIATION 0.83 • n=7 Participants	2.71 mmol/L STANDARD_DEVIATION 0.84 • n=5 Participants
HDL Cholesterol	1.24 mmol/L STANDARD_DEVIATION 0.30 • n=5 Participants	1.25 mmol/L STANDARD_DEVIATION 0.55 • n=7 Participants	1.24 mmol/L STANDARD_DEVIATION 0.40 • n=5 Participants
Total Cholesterol	4.76 mmol/L STANDARD_DEVIATION 1.00 • n=5 Participants	4.74 mmol/L STANDARD_DEVIATION 0.95 • n=7 Participants	4.75 mmol/L STANDARD_DEVIATION 0.98 • n=5 Participants
Triglycerides	1.85 mmol/L STANDARD_DEVIATION 0.94 • n=5 Participants	1.86 mmol/L STANDARD_DEVIATION 0.94 • n=7 Participants	1.85 mmol/L STANDARD_DEVIATION 0.94 • n=5 Participants
Average total MET	5246.83 Minutes/week STANDARD_DEVIATION 7145.63 • n=5 Participants	5463.48 Minutes/week STANDARD_DEVIATION 7958.59 • n=7 Participants	5318.24 Minutes/week STANDARD_DEVIATION 7412.94 • n=5 Participants
Smoking status Never smoker	144 Participants n=5 Participants	71 Participants n=7 Participants	215 Participants n=5 Participants
Smoking status Ex-smoker	90 Participants n=5 Participants	48 Participants n=7 Participants	138 Participants n=5 Participants
Smoking status Current smoker	25 Participants n=5 Participants	13 Participants n=7 Participants	38 Participants n=5 Participants
Smoking status Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Glycaemic Status Normogylcaemia	110 Participants n=5 Participants	66 Participants n=7 Participants	176 Participants n=5 Participants
Glycaemic Status Prediabetes	42 Participants n=5 Participants	20 Participants n=7 Participants	62 Participants n=5 Participants
Glycaemic Status Diabetes remission	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Glycaemic Status Diabetes	98 Participants n=5 Participants	41 Participants n=7 Participants	139 Participants n=5 Participants
Hypertension Status Yes	162 Participants n=5 Participants	88 Participants n=7 Participants	250 Participants n=5 Participants
Hypertension Status No	96 Participants n=5 Participants	44 Participants n=7 Participants	140 Participants n=5 Participants
Hypertension Status Missing	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sleep Apnoea Status Yes	124 Participants n=5 Participants	68 Participants n=7 Participants	192 Participants n=5 Participants
Sleep Apnoea Status No	113 Participants n=5 Participants	54 Participants n=7 Participants	167 Participants n=5 Participants
Sleep Apnoea Status Missing	23 Participants n=5 Participants	10 Participants n=7 Participants	33 Participants n=5 Participants
Number of all Medications None	55 Participants n=5 Participants	30 Participants n=7 Participants	85 Participants n=5 Participants
Number of all Medications One	24 Participants n=5 Participants	11 Participants n=7 Participants	35 Participants n=5 Participants
Number of all Medications Two	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Number of all Medications Three	32 Participants n=5 Participants	9 Participants n=7 Participants	41 Participants n=5 Participants
Number of all Medications Four	24 Participants n=5 Participants	7 Participants n=7 Participants	31 Participants n=5 Participants
Number of all Medications Five and over	108 Participants n=5 Participants	58 Participants n=7 Participants	166 Participants n=5 Participants
Number of Diabetes Medications Does not have diabetes	162 Participants n=5 Participants	91 Participants n=7 Participants	253 Participants n=5 Participants
Number of Diabetes Medications None	35 Participants n=5 Participants	12 Participants n=7 Participants	47 Participants n=5 Participants
Number of Diabetes Medications One	52 Participants n=5 Participants	22 Participants n=7 Participants	74 Participants n=5 Participants
Number of Diabetes Medications Two	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Number of Diabetes Medications Three and over	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Number of Antihypertensive Medications Does not have hypertension	98 Participants n=5 Participants	44 Participants n=7 Participants	142 Participants n=5 Participants
Number of Antihypertensive Medications None	44 Participants n=5 Participants	24 Participants n=7 Participants	68 Participants n=5 Participants
Number of Antihypertensive Medications One	55 Participants n=5 Participants	25 Participants n=7 Participants	80 Participants n=5 Participants
Number of Antihypertensive Medications Two	33 Participants n=5 Participants	22 Participants n=7 Participants	55 Participants n=5 Participants
Number of Antihypertensive Medications Three and over	30 Participants n=5 Participants	17 Participants n=7 Participants	47 Participants n=5 Participants
Statin Use Yes	70 Participants n=5 Participants	31 Participants n=7 Participants	101 Participants n=5 Participants
Statin Use No	190 Participants n=5 Participants	101 Participants n=7 Participants	291 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=201 Participants 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
Weight Loss of ≥15% From Baseline (Complete Cases)	6 Participants	51 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Weight Loss of ≥15% From Baseline (Intention to Treat)	6 Participants	55 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Per protocol population All participants who were compliant with their randomised treatment, analysed according to the treatment group to which they were randomised. Standard care group are compliant if they complete \>70% of the planned contacts in the T3 service. The intervention group are compliant if they complete \>70% of the planned contacts in the T3 service, and take \>70% of their prescribed LIRA 3mg. Excludes participants who had bariatric surgery during the study period.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=51 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=108 Participants 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
Weight Loss of ≥15% From Baseline (Per Protocol)	5 Participants	40 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Per protocol population. All participants who were compliant with their randomised treatment, analysed according to the treatment group to which they were randomised. Standard care group are compliant if they complete \>70% of the planned contacts in the T3 service. The intervention group are compliant if they complete \>70% of the planned contacts in the T3 service, and take \>70% of their prescribed LIRA 3mg. Excludes participants who had bariatric surgery during the study period.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=50 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=105 Participants 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
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)	5 Participants	40 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

Attended at least 70% of scheduled Tier 3 appointments by 52 weeks

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Participant Attendance at Appointments (Intention to Treat) No	1 Participants	0 Participants
Participant Attendance at Appointments (Intention to Treat) Yes	51 Participants	115 Participants
Participant Attendance at Appointments (Intention to Treat) Did not attend week 52 visit	43 Participants	60 Participants
Participant Attendance at Appointments (Intention to Treat) Attended week 52 visit but variable missing	37 Participants	85 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

Attended at least 70% of scheduled Tier 3 appointments by 104 weeks

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Participant Attendance at Appointments (Intention to Treat) No	0 Participants	0 Participants
Participant Attendance at Appointments (Intention to Treat) Yes	46 Participants	92 Participants
Participant Attendance at Appointments (Intention to Treat) Did not attend week 104 visit	66 Participants	117 Participants
Participant Attendance at Appointments (Intention to Treat) Attended week 104 visit but variable missing	20 Participants	51 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Cessation of Treatment Due to Adverse Effects (Intention to Treat) No	NA Participants This is for Liraglutide arm only.	111 Participants
Cessation of Treatment Due to Adverse Effects (Intention to Treat) Yes	NA Participants This is for Liraglutide arm only.	3 Participants
Cessation of Treatment Due to Adverse Effects (Intention to Treat) N/A	NA Participants This is for Liraglutide arm only.	146 Participants
Cessation of Treatment Due to Adverse Effects (Intention to Treat) Missing	NA Participants This is for Liraglutide arm only.	0 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Cessation of Treatment Due to Adverse Effects (Intention to Treat) No	NA Participants This is for Liraglutide arm only.	53 Participants
Cessation of Treatment Due to Adverse Effects (Intention to Treat) Yes	NA Participants This is for Liraglutide arm only.	2 Participants
Cessation of Treatment Due to Adverse Effects (Intention to Treat) N/A	NA Participants This is for Liraglutide arm only.	205 Participants
Cessation of Treatment Due to Adverse Effects (Intention to Treat) Missing	NA Participants This is for Liraglutide arm only.	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Participant Compliance With Treatment (Intention to Treat) No	NA Participants This is for Liraglutide arm only.	23 Participants
Participant Compliance With Treatment (Intention to Treat) Yes	NA Participants This is for Liraglutide arm only.	233 Participants
Participant Compliance With Treatment (Intention to Treat) Missing	NA Participants This is for Liraglutide arm only.	4 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Participant Compliance With Treatment (Intention to Treat) No	NA Participants This is for Liraglutide arm only.	27 Participants
Participant Compliance With Treatment (Intention to Treat) Yes	NA Participants This is for Liraglutide arm only.	229 Participants
Participant Compliance With Treatment (Intention to Treat) Missing	NA Participants This is for Liraglutide arm only.	4 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Patient Stopping of Treatment (Intention to Treat) No	NA Participants For Liraglutide arm only.	181 Participants
Patient Stopping of Treatment (Intention to Treat) Yes	NA Participants For Liraglutide arm only.	79 Participants
Patient Stopping of Treatment (Intention to Treat) Missing	NA Participants For Liraglutide arm only.	0 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who were on liraglutide 3mg treatment at the previous time-point.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=181 Participants 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
Patient Stopping of Treatment (Intention to Treat) No	NA Participants For Liraglutide arm only.	110 Participants
Patient Stopping of Treatment (Intention to Treat) Yes	NA Participants For Liraglutide arm only.	71 Participants
Patient Stopping of Treatment (Intention to Treat) Missing	NA Participants For Liraglutide arm only.	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who were on liraglutide 3mg treatment at the previous time-point.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=110 Participants 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
Patient Stopping of Treatment (Intention to Treat) No	NA Participants For Liraglutide arm only.	53 Participants
Patient Stopping of Treatment (Intention to Treat) Yes	NA Participants For Liraglutide arm only.	57 Participants
Patient Stopping of Treatment (Intention to Treat) Missing	NA Participants For Liraglutide arm only.	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) No	NA Participants For Liraglutide arm only.	60 Participants
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) Yes	NA Participants For Liraglutide arm only.	19 Participants
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) N/A (still using Liraglutide 3mg at 16 weeks)	NA Participants For Liraglutide arm only.	181 Participants
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) Missing	NA Participants For Liraglutide arm only.	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who stopped liraglutide 3mg treatment at 32 weeks.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=181 Participants 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
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) No	NA Participants For Liraglutide arm only.	49 Participants
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) Yes	NA Participants For Liraglutide arm only.	22 Participants
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) N/A (still using Liraglutide 3mg at 32 weeks)	NA Participants For Liraglutide arm only.	110 Participants
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) Missing	NA Participants For Liraglutide arm only.	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) No	92 Participants	203 Participants
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) Yes	1 Participants	3 Participants
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) Missing	39 Participants	54 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

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.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) No	64 Participants	144 Participants
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) Yes	2 Participants	3 Participants
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) Missing	66 Participants	113 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

Number of participants referred to Tier 4 for bariatric surgery over the 104 weeks study period

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Referral to Other Obesity Interventions (Intention to Treat) No	64 Participants	125 Participants
Referral to Other Obesity Interventions (Intention to Treat) Yes	5 Participants	25 Participants
Referral to Other Obesity Interventions (Intention to Treat) Missing	63 Participants	110 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.

Referrals for bariatric surgery by 104 weeks, stratified by study site.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Referral to Other Obesity Interventions by Site (Intention to Treat) Dublin	3 Participants	3 Participants
Referral to Other Obesity Interventions by Site (Intention to Treat) Glasgow	0 Participants	0 Participants
Referral to Other Obesity Interventions by Site (Intention to Treat) Leicester	0 Participants	10 Participants
Referral to Other Obesity Interventions by Site (Intention to Treat) Liverpool	1 Participants	2 Participants
Referral to Other Obesity Interventions by Site (Intention to Treat) London	1 Participants	10 Participants
Referral to Other Obesity Interventions by Site (Intention to Treat) Not referred / missing	127 Participants	235 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed.

Number of participants who underwent bariatric surgery by 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=132 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 Participants 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
Bariatric Surgery Completion (Intention to Treat) No	64 Participants	142 Participants
Bariatric Surgery Completion (Intention to Treat) Yes	4 Participants	6 Participants
Bariatric Surgery Completion (Intention to Treat) Missing	64 Participants	112 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline, at 16 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=237 Participants 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
Weight Loss of ≥5% From Baseline (Complete Cases)	34 Participants	186 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline, at 32 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=208 Participants 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
Weight Loss of ≥5% From Baseline (Complete Cases)	34 Participants	158 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline, at 52 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=201 Participants 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
Weight Loss of ≥5% From Baseline (Complete Cases)	29 Participants	127 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline, at 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=132 Participants 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
Weight Loss of ≥5% From Baseline (Complete Cases)	17 Participants	62 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline, at 16 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=237 Participants 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
Weight Loss of ≥10% From Baseline (Complete Cases)	9 Participants	60 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline, at 32 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=208 Participants 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
Weight Loss of ≥10% From Baseline (Complete Cases)	14 Participants	110 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline, at 52 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=201 Participants 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
Weight Loss of ≥10% From Baseline (Complete Cases)	9 Participants	90 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline, at 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=132 Participants 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
Weight Loss of ≥10% From Baseline (Complete Cases)	8 Participants	32 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=237 Participants 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
Weight Loss of ≥15% From Baseline (Complete Cases)	2 Participants	10 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=208 Participants 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
Weight Loss of ≥15% From Baseline (Complete Cases)	5 Participants	32 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=132 Participants 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
Weight Loss of ≥15% From Baseline (Complete Cases)	2 Participants	15 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Proportion of participants maintaining weight loss of ≥15% among those who lost ≥15% at 52 weeks

Outcome measures

Outcome measures
Measure	Standard Care Arm n=5 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=41 Participants 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
Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases)	2 Participants	12 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in weight (kg) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=237 Participants 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
Absolute Weight Change (Complete Cases)	-5.54 kg Standard Deviation 5.87	-9.61 kg Standard Deviation 5.38

SECONDARY outcome

Timeframe: 32 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in weight (kg) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=208 Participants 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
Absolute Weight Change (Complete Cases)	-5.70 kg Standard Deviation 7.16	-11.27 kg Standard Deviation 7.70

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in weight (kg) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=201 Participants 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
Absolute Weight Change (Complete Cases)	-3.21 kg Standard Deviation 8.66	-10.15 kg Standard Deviation 9.45

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in weight (kg) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=132 Participants 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
Absolute Weight Change (Complete Cases)	-1.27 kg Standard Deviation 10.30	-6.51 kg Standard Deviation 9.28

SECONDARY outcome

Timeframe: 16 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=237 Participants 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
Percentage Weight Change (Complete Cases)	-4.39 percentage Standard Deviation 4.45	-7.63 percentage Standard Deviation 4.02

SECONDARY outcome

Timeframe: 32 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=208 Participants 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
Percentage Weight Change (Complete Cases)	-4.58 percentage Standard Deviation 5.74	-9.00 percentage Standard Deviation 5.82

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=201 Participants 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
Percentage Weight Change (Complete Cases)	-2.67 percentage Standard Deviation 6.79	-8.13 percentage Standard Deviation 7.21

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=132 Participants 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
Percentage Weight Change (Complete Cases)	-1.21 percentage Standard Deviation 8.16	-5.18 percentage Standard Deviation 7.47

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in BMI (kg/m2) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=80 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=180 Participants 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
Absolute BMI Change (Complete Cases)	-1.17 kg/m2 Standard Deviation 2.84	-3.84 kg/m2 Standard Deviation 3.29

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in BMI (kg/m2) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=132 Participants 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
Absolute BMI Change (Complete Cases)	-0.49 kg/m2 Standard Deviation 3.57	-2.30 kg/m2 Standard Deviation 3.29

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in waist circumference (cm) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=58 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=137 Participants 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
Absolute Waist Circumference Change (Complete Cases)	-5.58 Centimetres Standard Deviation 8.48	-8.88 Centimetres Standard Deviation 7.89

SECONDARY outcome

Timeframe: 104 weeks

Absolute change in waist circumference (cm) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=48 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=101 Participants 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
Absolute Waist Circumference Change (Complete Cases)	-0.93 Centimetres Standard Deviation 12.54	-6.42 Centimetres Standard Deviation 8.44

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=63 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=145 Participants 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
Kings College Obesity Staging (KCOS) Score (Complete Cases) Normal health at baseline	0 Participants	0 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Normal health at follow-up	0 Participants	1 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) At risk of disease at baseline	5 Participants	6 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) At risk of disease at follow-up	12 Participants	23 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Established disease at baseline	41 Participants	97 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Established disease at follow-up	43 Participants	108 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Advanced disease at baseline	17 Participants	42 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Advanced disease at follow-up	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=51 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=115 Participants 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
Kings College Obesity Staging (KCOS) Score (Complete Cases) Normal health at baseline	0 Participants	0 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Normal health at follow-up	0 Participants	2 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) At risk of disease at baseline	4 Participants	5 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) At risk of disease at follow-up	10 Participants	16 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Established disease at baseline	37 Participants	84 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Established disease at follow-up	35 Participants	86 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Advanced disease at baseline	10 Participants	26 Participants
Kings College Obesity Staging (KCOS) Score (Complete Cases) Advanced disease at follow-up	6 Participants	11 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=63 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=139 Participants 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
Patient Health Questionnaire-9 (Complete Cases) Minimal depression at baseline	16 Participants	27 Participants
Patient Health Questionnaire-9 (Complete Cases) Minimal depression at follow-up	24 Participants	48 Participants
Patient Health Questionnaire-9 (Complete Cases) Mild depression at baseline	15 Participants	33 Participants
Patient Health Questionnaire-9 (Complete Cases) Mild depression at follow-up	9 Participants	30 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderate depression at baseline	23 Participants	29 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderate depression at follow-up	14 Participants	27 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderately severe depression at baseline	2 Participants	32 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderately severe depression at follow-up	6 Participants	18 Participants
Patient Health Questionnaire-9 (Complete Cases) Severe depression at baseline	7 Participants	18 Participants
Patient Health Questionnaire-9 (Complete Cases) Severe depression at follow-up	10 Participants	16 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=50 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=102 Participants 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
Patient Health Questionnaire-9 (Complete Cases) Minimal depression at baseline	15 Participants	19 Participants
Patient Health Questionnaire-9 (Complete Cases) Minimal depression at follow-up	17 Participants	32 Participants
Patient Health Questionnaire-9 (Complete Cases) Mild depression at baseline	10 Participants	27 Participants
Patient Health Questionnaire-9 (Complete Cases) Mild depression at follow-up	16 Participants	26 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderate depression at baseline	18 Participants	20 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderate depression at follow-up	10 Participants	21 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderately severe depression at baseline	3 Participants	23 Participants
Patient Health Questionnaire-9 (Complete Cases) Moderately severe depression at follow-up	4 Participants	12 Participants
Patient Health Questionnaire-9 (Complete Cases) Severe depression at baseline	4 Participants	13 Participants
Patient Health Questionnaire-9 (Complete Cases) Severe depression at follow-up	3 Participants	11 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24. A higher value corresponds with a worse outcome.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=62 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=145 Participants 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
Epworth Sleepiness Scale (Complete Cases) No obstructive sleep apnoea at baseline	47 Participants	111 Participants
Epworth Sleepiness Scale (Complete Cases) No obstructive sleep apnoea at follow-up	50 Participants	119 Participants
Epworth Sleepiness Scale (Complete Cases) Possible obstructive sleep apnoea at baseline	15 Participants	34 Participants
Epworth Sleepiness Scale (Complete Cases) Possible obstructive sleep apnoea at follow-up	12 Participants	26 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24. A higher value corresponds with a worse outcome.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=55 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=110 Participants 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
Epworth Sleepiness Scale (Complete Cases) No obstructive sleep apnoea at baseline	38 Participants	85 Participants
Epworth Sleepiness Scale (Complete Cases) No obstructive sleep apnoea at follow-up	44 Participants	90 Participants
Epworth Sleepiness Scale (Complete Cases) Possible obstructive sleep apnoea at baseline	17 Participants	25 Participants
Epworth Sleepiness Scale (Complete Cases) Possible obstructive sleep apnoea at follow-up	11 Participants	20 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8. A higher value corresponds with a worse outcome.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=44 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=93 Participants 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
Stop Bang Questionnaire (Complete Cases) No obstructive sleep apnoea at baseline	4 Participants	10 Participants
Stop Bang Questionnaire (Complete Cases) No obstructive sleep apnoea at follow-up	10 Participants	18 Participants
Stop Bang Questionnaire (Complete Cases) Possible obstructive sleep apnoea at baseline	12 Participants	34 Participants
Stop Bang Questionnaire (Complete Cases) Possible obstructive sleep apnoea at follow-up	14 Participants	43 Participants
Stop Bang Questionnaire (Complete Cases) Likely obstructive sleep apnoea at baseline	28 Participants	49 Participants
Stop Bang Questionnaire (Complete Cases) Likely obstructive sleep apnoea at follow-up	20 Participants	32 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8. A higher value corresponds with a worse outcome.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=40 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=84 Participants 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
Stop Bang Questionnaire (Complete Cases) No obstructive sleep apnoea at baseline	3 Participants	11 Participants
Stop Bang Questionnaire (Complete Cases) No obstructive sleep apnoea at follow-up	4 Participants	12 Participants
Stop Bang Questionnaire (Complete Cases) Possible obstructive sleep apnoea at baseline	13 Participants	26 Participants
Stop Bang Questionnaire (Complete Cases) Possible obstructive sleep apnoea at follow-up	13 Participants	38 Participants
Stop Bang Questionnaire (Complete Cases) Likely obstructive sleep apnoea at baseline	24 Participants	47 Participants
Stop Bang Questionnaire (Complete Cases) Likely obstructive sleep apnoea at follow-up	23 Participants	34 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=56 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=165 Participants 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
Glycaemic Status (Complete Cases) Normoglycaemia at baseline	24 Participants	52 Participants
Glycaemic Status (Complete Cases) Normoglycaemia at follow-up	24 Participants	67 Participants
Glycaemic Status (Complete Cases) Prediabetes at baseline	9 Participants	21 Participants
Glycaemic Status (Complete Cases) Prediabetes at follow-up	7 Participants	10 Participants
Glycaemic Status (Complete Cases) Diabetes remission at baseline	2 Participants	8 Participants
Glycaemic Status (Complete Cases) Diabetes remission at follow-up	2 Participants	0 Participants
Glycaemic Status (Complete Cases) Diabetes at baseline	21 Participants	84 Participants
Glycaemic Status (Complete Cases) Diabetes at follow-up	23 Participants	88 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.

Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=46 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=101 Participants 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
Glycaemic Status (Complete Cases) Normoglycaemia at baseline	19 Participants	25 Participants
Glycaemic Status (Complete Cases) Normoglycaemia at follow-up	15 Participants	31 Participants
Glycaemic Status (Complete Cases) Prediabetes at baseline	7 Participants	13 Participants
Glycaemic Status (Complete Cases) Prediabetes at follow-up	8 Participants	8 Participants
Glycaemic Status (Complete Cases) Diabetes remission at baseline	1 Participants	5 Participants
Glycaemic Status (Complete Cases) Diabetes remission at follow-up	1 Participants	0 Participants
Glycaemic Status (Complete Cases) Diabetes at baseline	19 Participants	58 Participants
Glycaemic Status (Complete Cases) Diabetes at follow-up	22 Participants	62 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants HbA1c ≤7% at 52 weeks, among those with diabetes at baseline.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=17 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=54 Participants 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
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) No	11 Participants	10 Participants
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) Yes	6 Participants	44 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants HbA1c ≤7% at 104 weeks, among those with diabetes at baseline.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=17 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=39 Participants 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
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) No	10 Participants	10 Participants
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) Yes	7 Participants	29 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants HbA1c ≤6.5% at 52 weeks, among those with diabetes at baseline.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=17 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=54 Participants 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
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) No	14 Participants	17 Participants
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) Yes	3 Participants	37 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants HbA1c ≤6.5% at 104 weeks, among those with diabetes at baseline.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=17 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=39 Participants 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
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) No	12 Participants	16 Participants
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) Yes	5 Participants	23 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants with hypertension at 52 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=80 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=172 Participants 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
Hypertension (Complete Cases) Hypertension at baseline · No	20 Participants	37 Participants
Hypertension (Complete Cases) Hypertension at baseline · Yes	60 Participants	135 Participants
Hypertension (Complete Cases) Hypertension at follow-up · No	21 Participants	41 Participants
Hypertension (Complete Cases) Hypertension at follow-up · Yes	59 Participants	131 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants with hypertension at 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=58 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=127 Participants 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
Hypertension (Complete Cases) Hypertension at baseline · No	16 Participants	35 Participants
Hypertension (Complete Cases) Hypertension at baseline · Yes	42 Participants	92 Participants
Hypertension (Complete Cases) Hypertension at follow-up · No	15 Participants	38 Participants
Hypertension (Complete Cases) Hypertension at follow-up · Yes	43 Participants	89 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline at 16 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=54 Participants 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
Weight Loss of ≥5% From Baseline (Responder Population)	34 Participants	54 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline at 32 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=53 Participants 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
Weight Loss of ≥5% From Baseline (Responder Population)	34 Participants	53 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline at 52 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=51 Participants 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
Weight Loss of ≥5% From Baseline (Responder Population)	29 Participants	51 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥5% from baseline at 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=42 Participants 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
Weight Loss of ≥5% From Baseline (Responder Population)	17 Participants	33 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline at 16 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=54 Participants 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
Weight Loss of ≥10% From Baseline (Responder Population)	9 Participants	34 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline at 32 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=53 Participants 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
Weight Loss of ≥10% From Baseline (Responder Population)	14 Participants	53 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline at 52 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=51 Participants 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
Weight Loss of ≥10% From Baseline (Responder Population)	9 Participants	51 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥10% from baseline at 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=42 Participants 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
Weight Loss of ≥10% From Baseline (Responder Population)	8 Participants	23 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=54 Participants 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
Weight Loss of ≥15% From Baseline (Responder Population)	2 Participants	8 Participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=53 Participants 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
Weight Loss of ≥15% From Baseline (Responder Population)	5 Participants	24 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥15% from baseline at 52 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=51 Participants 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
Weight Loss of ≥15% From Baseline (Responder Population)	6 Participants	51 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=42 Participants 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
Weight Loss of ≥15% From Baseline (Responder Population)	2 Participants	12 Participants

SECONDARY outcome

Timeframe: 104 weeks

Population: Complete cases. All individuals in both arms (intervention and control group) who have data available for the outcome being analysed (proportion of participants who maintained at 104 weeks weight loss of \>=15% among those who lost \>=15% weight loss at 52 weeks) according to the study group to which they were randomised. Participants who had bariatric surgery during the study period were excluded from this population.

Proportion of participants who maintained weight loss of ≥15% among those who lost ≥15% at 52 weeks.

Outcome measures

Outcome measures
Measure	Standard Care Arm n=5 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=41 Participants 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
Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population)	2 Participants	12 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=86 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=54 Participants 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
Percentage Weight Change (Responder Population)	-4.39 percentage Standard Deviation 4.45	-11.45 percentage Standard Deviation 3.62

SECONDARY outcome

Timeframe: 32 weeks

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=79 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=53 Participants 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
Percentage Weight Change (Responder Population)	-4.58 percentage Standard Deviation 5.74	-14.82 percentage Standard Deviation 3.85

SECONDARY outcome

Timeframe: 52 weeks

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=93 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=51 Participants 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
Percentage Weight Change (Responder Population)	-2.67 percentage Standard Deviation 6.79	-17.21 percentage Standard Deviation 2.43

SECONDARY outcome

Timeframe: 104 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Percentage change in weight from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=42 Participants 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
Percentage Weight Change (Responder Population)	-1.21 percentage Standard Deviation 8.16	-11.01 percentage Standard Deviation 6.70

SECONDARY outcome

Timeframe: 52 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in BMI (kg/m2) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=80 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=50 Participants 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
Absolute BMI Change (Responder Population)	-1.17 kg/m2 Standard Deviation 2.84	-7.65 kg/m2 Standard Deviation 1.65

SECONDARY outcome

Timeframe: 104 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in BMI (kg/m2) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=61 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=42 Participants 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
Absolute BMI Change (Responder Population)	-0.49 kg/m2 Standard Deviation 3.57	-4.86 kg/m2 Standard Deviation 2.91

SECONDARY outcome

Timeframe: 52 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in waist circumference (cm) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=58 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=42 Participants 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
Absolute Waist Circumference Change (Responder Population)	-5.58 Centimetres Standard Deviation 8.48	-15.33 Centimetres Standard Deviation 6.02

SECONDARY outcome

Timeframe: 104 weeks

Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.

Absolute change in waist circumference (cm) from baseline

Outcome measures

Outcome measures
Measure	Standard Care Arm n=48 Participants Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=34 Participants 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
Absolute Waist Circumference Change (Responder Population)	-0.93 Centimetres Standard Deviation 12.54	-10.20 Centimetres Standard Deviation 8.42

Adverse Events

Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)

Serious events: 43 serious events

Other events: 238 other events

Deaths: 2 deaths

Standard Care Arm

Serious events: 16 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Prof Melanie Davies

University of Leicester

Phone: 0116 258 6481

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) n=260 participants at risk 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	Standard Care Arm n=132 participants at risk Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
Gastrointestinal disorders Diarrhoea	27.7% 72/260 • Number of events 92 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	6.1% 8/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Infections and infestations Ear infection	1.9% 5/260 • Number of events 6 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	7.6% 10/132 • Number of events 12 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	13.1% 34/260 • Number of events 43 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	11.4% 15/132 • Number of events 16 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Nervous system disorders Headache	14.6% 38/260 • Number of events 49 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	1.5% 2/132 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
General disorders Asthenic conditions	11.5% 30/260 • Number of events 32 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	2.3% 3/132 • Number of events 3 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Gastrointestinal disorders Dyspepsia	14.6% 38/260 • Number of events 44 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	0.00% 0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Gastrointestinal disorders Flatulence	12.7% 33/260 • Number of events 39 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	0.00% 0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Gastrointestinal disorders Gastrointestinal pain	14.2% 37/260 • Number of events 48 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	3.8% 5/132 • Number of events 6 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Gastrointestinal disorders Gastrointestinal hypomotility	35.8% 93/260 • Number of events 117 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	9.1% 12/132 • Number of events 12 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Gastrointestinal disorders Nausea	41.9% 109/260 • Number of events 183 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	3.8% 5/132 • Number of events 5 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Infections and infestations Influenza	5.4% 14/260 • Number of events 15 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	3.8% 5/132 • Number of events 5 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Infections and infestations Lower respiratory tract infection	15.8% 41/260 • Number of events 63 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	12.9% 17/132 • Number of events 22 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Infections and infestations Upper respiratory tract infection	6.9% 18/260 • Number of events 19 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	6.1% 8/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Infections and infestations Urinary tract infection	8.1% 21/260 • Number of events 26 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	3.8% 5/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Infections and infestations Viral infection	13.8% 36/260 • Number of events 41 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	5.3% 7/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
Nervous system disorders Neurological symptom	10.4% 27/260 • Number of events 31 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.	4.5% 6/132 • Number of events 6 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.