Trial Outcomes & Findings for Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity (NCT NCT03799198)

NCT ID: NCT03799198

Last Updated: 2022-11-14

Results Overview

Percentage change in body weight from baseline (month 0) to month 12 is presented.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

Month 0, month 12

Results posted on

2022-11-14

Participant Flow

The trial was conducted at a single site in the United States.

Participants were randomized in a 1:1 manner to receive either Cleveland Clinic's Integrated Medical Weight Management Program (WMP) with medication for chronic weight management (WMP + Rx) or Cleveland Clinic's Integrated Medical WMP alone (WMP).

Participant milestones

Participant milestones
Measure	Weight Management Program (WMP) + Rx Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Overall Study STARTED	100	100
Overall Study Full Analysis Set (FAS)	100	100
Overall Study COMPLETED	96	91
Overall Study NOT COMPLETED	4	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Weight Management Program (WMP) + Rx Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Overall Study Lost to Follow-up	4	8
Overall Study Death	0	1

Baseline Characteristics

Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.	Total n=200 Participants Total of all reporting groups
Age, Continuous	51.0 years STANDARD_DEVIATION 10.43 • n=5 Participants	49.1 years STANDARD_DEVIATION 10.11 • n=7 Participants	50.0 years STANDARD_DEVIATION 10.29 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	89 Participants n=7 Participants	177 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=5 Participants	100 Participants n=7 Participants	196 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	80 Participants n=5 Participants	66 Participants n=7 Participants	146 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	19 Participants n=5 Participants	33 Participants n=7 Participants	52 Participants n=5 Participants
Race/Ethnicity, Customized Asian/White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized India	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants.

Percentage change in body weight from baseline (month 0) to month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in Body Weight	-7.69 Percent change of body weight Standard Error 0.72	-4.19 Percent change of body weight Standard Error 0.73

SECONDARY outcome

Timeframe: Month 12

Population: The FAS comprised of all randomized participants.

The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Participants Achieving 5% or More Reduction in Body Weight	62.5 Percentage of participants	44.8 Percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: The FAS comprised of all randomized participants.

The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Participants Achieving 10% or More Reduction in Body Weight	34.7 Percentage of participants	22.4 Percentage of participants

SECONDARY outcome

Timeframe: Months 0-12

Population: The FAS comprised of all randomized participants.

Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Number of Shared Medical Appointments (SMAs) Attended	9.7 SMAs Standard Deviation 2.98	7.4 SMAs Standard Deviation 3.90

SECONDARY outcome

Timeframe: Months 0-12

Population: The FAS comprised of all randomized participants.

Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Participants Attending 9 or More SMAs	79 Participants	51 Participants

SECONDARY outcome

Timeframe: Months 0-12

Population: The FAS comprised of all randomized participants.

Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management	66.48 Proportion of days Standard Deviation 27.096	—

SECONDARY outcome

Timeframe: Months 0-12

Population: The FAS comprised of all randomized participants.

Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days	43 Participants	—

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=98 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)	-0.06 Score on a scale Standard Error 0.06	-0.03 Score on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=98 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=95 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Time Management' as Measured by WLQ-8	-0.10 Score on a scale Standard Error 0.07	-0.19 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=99 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=98 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Physical Tasks' as Measured by WLQ-8	-0.09 Score on a scale Standard Error 0.11	-0.05 Score on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=98 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=97 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8	-0.06 Score on a scale Standard Error 0.09	-0.03 Score on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=97 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=98 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Output Tasks' as Measured by WLQ-8	0.07 Score on a scale Standard Error 0.10	0.12 Score on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=95 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=95 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)	-0.43 Score on a scale Standard Error 0.17	-0.48 Score on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=95 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=95 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP	-1.88 Score on a scale Standard Error 1.62	-1.94 Score on a scale Standard Error 1.82

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=95 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=95 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP	-1.84 Score on a scale Standard Error 1.62	-1.89 Score on a scale Standard Error 1.82

SECONDARY outcome

Timeframe: Month 0, month 12

Population: The FAS comprised of all randomized participants.

Outcome measures

Outcome measures
Measure	Weight Management Program (WMP) + Rx n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 Participants Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP	-9.95 Score on a scale Standard Error 2.53	-7.20 Score on a scale Standard Error 2.69

Adverse Events

Weight Management Program (WMP) + Rx

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Weight Management Program (WMP)

Serious events: 11 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Clinical Transparency and Medical Writing Office (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER

Measure	Weight Management Program (WMP) + Rx n=100 participants at risk Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Weight Management Program (WMP) n=100 participants at risk Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Cardiac disorders Atrial Fibrillation	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Cardiac disorders Atrial Tachycardia	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Cardiac disorders Congestive Cardiomyopathy	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Gastrointestinal disorders Appendicitis	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Gastrointestinal disorders Gastroenteritis Salmonella	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Gastrointestinal disorders Procedural Vomiting	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Metabolism and nutrition disorders Dehydration	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Metabolism and nutrition disorders Malnutrition	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Musculoskeletal and connective tissue disorders Arthralgia	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Blood and lymphatic system disorders Plasma Cell Myeloma	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
General disorders Non-Cardiac Chest Pain	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Hepatobiliary disorders Cholelithiasis	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Infections and infestations Pyelonephritis	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid Tumour Benign	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Nervous system disorders Syncope	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Psychiatric disorders Depression Suicidal	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Reproductive system and breast disorders Ovarian Mass	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Skin and subcutaneous tissue disorders Skin Lesion	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Social circumstances Organ Donor	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Surgical and medical procedures Gastric Bypass	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Vascular disorders Dizziness	1.0% 1/100 • Number of events 1 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.	0.00% 0/100 • Months 0 - 12 All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.