Trial Outcomes & Findings for Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes (NCT NCT05533632)

NCT ID: NCT05533632

Last Updated: 2025-09-24

Results Overview

Number of adverse events from baseline (Day 1) to week 24 is presented. An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 104 participants
• Primary outcome timeframe: From baseline (Day 1) up to 24 weeks
• Results posted on: 2025-09-24

Participant Flow

The trial was conducted at 3 sites in Chile.

Participant milestones

Measure	Semaglutide Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Overall Study STARTED	104
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Semaglutide Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Overall Study Participant no longer wants to participate in study, has other priorities	1
Overall Study Participant moved to another city and will not come back to Santiago	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	4
Overall Study Adverse Event	4

Baseline Characteristics

Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Age, Continuous	58.3 Years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race/Ethnicity, Customized Indigenous	3 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants
Race/Ethnicity, Customized No specific ethnicity	60 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline (Day 1) up to 24 weeks

Population: Full analysis set (FAS) included all participants exposed to the study product.

Number of adverse events from baseline (Day 1) to week 24 is presented. An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Number of Adverse Events (AEs)	45 Events

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in glycosylated haemoglobin (HbA1c) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Glycosylated Haemoglobin (HbA1c)	-1.6 Percentage of HbA1c Standard Deviation 1.0

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Participants achieving HbA1c less than 7.0% (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No] Yes	52 Participants
Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No] No	40 Participants

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in fasting plasma glucose (FPG) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]	-26.2 mg/dL Standard Deviation 61.3

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in body weight from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Body Weight (Kilogram [Kg])	-5.3 Kg Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in waist circumference from baseline (week 1) to week 24 is presented. Waist circumference is defined as the minimal abdominal circumference located midway between the lower rib margin and the iliac crest. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Waist Circumference [Centimeter (cm)]	-5.7 cm Standard Deviation 5.7

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Participants achieving greater than or equal (≥) 5% weight reduction (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No) Yes	56 Participants
Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No) No	36 Participants

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Participants achieving greater than or equal (≥) 10% weight reduction (Yes/No) from baseline (week 1) to week is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No) Yes	17 Participants
Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No) No	75 Participants

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in total cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Total Cholesterol (mg/dL)	-14.1 mg/dL Standard Deviation 26.0

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in low density lipoprotein (LDL) cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=87 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)	-12.5 mg/dL Standard Deviation 26.9

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in high density lipoprotein (HDL) cholesterol (mg/dL) cholesterol from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL)	-1.1 mg/dL Standard Deviation 5.2

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in triglycerides (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Triglycerides (mg/dL)	-13.8 mg/dL Standard Deviation 105.2

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in estimated glomerular filtration rate (eGFR) [millilitre per minute (mL/min) per 1.73 square meter (m^2)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)]	-1.1 mL/min per 1.73 m^2 Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change in Urine Albumin-Creatinine Ratio (UACR) [milligram per gram (mg/g)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=88 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)]	-18.0 mg/g Standard Deviation 410.8

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product.

Participants discontinued due to adverse events (treatment discontinuation) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Participants Discontinued Due to Adverse Events (Treatment Discontinuation)	4 Participants

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product.

Number of severe hypoglycaemic episodes from baseline (week 1) to week 24 is presented. Hypoglycaemic episodes were classified as severe if there was no specific glucose threshold but were associated with severe cognitive impairment requiring external assistance for recovery. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Number of Severe Hypoglycaemic Episodes	0 Episodes

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product.

Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes Severe	0 Episodes
Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes Symptomatic	2 Episodes

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product.

Number of serious adverse events (SAEs) from baseline (week 1) to week 24 is presented. An SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; important medical event. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Number of Serious Adverse Events (SAEs)	1 Events

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product.

Number of adverse reactions (ARs) from baseline (week 1) to week 24 is presented. Adverse reaction is an undesired effect of a drug or other type of treatment that can range from mild to severe and can be life-threatening. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Number of Adverse Reactions (ARs)	39 Events

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product.

Number of serious adverse reactions (SARs) from baseline (week 1) to week 24 is presented. Serious adverse reaction is an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Number of Serious Adverse Reactions (SARs)	0 Events

SECONDARY outcome

Timeframe: From baseline (week 1) to week 24

Population: Full analysis set (FAS) included all participants exposed to the study product.

Number of suspected unexpected serious adverse reactions (SUSARs) per participant from baseline (week 1) to week 24 is presented. SUSAR is a serious adverse event which is unexpected and regarded as possibly or probably related to the trial product. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Outcome measures

Measure	Semaglutide n=104 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant	0 Events

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Population: Full analysis set (FAS) included all participants exposed to the study product. Overall Number of Participants Analysed = participants with available data.

Change from baseline in heart rate (pulse) after 24 weeks of treatment is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Outcome measures

Measure	Semaglutide n=92 Participants Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment	2.9 beats per minute (bpm) Standard Deviation 11.2

Adverse Events

Semaglutide

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Semaglutide n=104 participants at risk Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Cardiac disorders Acute myocardial infarction	0.96% 1/104 • Number of events 1 • Baseline (Day 1) up to Week 24 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date (or increase in severity) during on-treatment observation period. Full analysis set (FAS) included all participants exposed to the study product.

Other adverse events

Measure	Semaglutide n=104 participants at risk Participants received subcutaneous (s.c.) injection of Semaglutide once-weekly in a dose escalation manner for 24 weeks: 0.25 milligrams \[mg\], (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).
Gastrointestinal disorders Diarrhea	5.8% 6/104 • Number of events 6 • Baseline (Day 1) up to Week 24 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date (or increase in severity) during on-treatment observation period. Full analysis set (FAS) included all participants exposed to the study product.
Gastrointestinal disorders Nausea	11.5% 12/104 • Number of events 14 • Baseline (Day 1) up to Week 24 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date (or increase in severity) during on-treatment observation period. Full analysis set (FAS) included all participants exposed to the study product.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

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