Research Study Looking at How Well Semaglutide Tablets Ta... | NCT05564117

ID	Type	Description	Link
U1111-1271-9056	Other Identifier	World Health Organization (WHO)
2021-006534-40	EudraCT Number

Label	Type	Description	Intervention Names
Oral semaglutide 25 mg	Experimental	Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).	Drug: Semaglutide
Oral semaglutide placebo	Placebo Comparator	Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.	Drug: Placebo semaglutide

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Semaglutide tablets orally once daily for 64 weeks.	Oral semaglutide 25 mg

Measure	Description	Time Frame
Percentage Change in Body Weight	Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.	Baseline (week 0), end of treatment (week 64)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)	Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.	At end of treatment (week 64)

Measure	Description	Time Frame
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)	Number of participants who achieved ≥ 10% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.

Name	Affiliation	Role
Clinical Transparency dept. 2834	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univsty Of AL At Birmingham		Birmingham	Alabama	35294	United States
FDRC

PubMed Identifier	Type	Citation	Retractions
40934115	Derived	Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT; OASIS 4 Study Group. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025 Sep 18;393(11):1077-1087. doi: 10.1056/NEJMoa2500969.

ID	Title	Description
FG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
FG001	Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 17, 2022	Jan 20, 2026

Primary

Percentage Change in Body Weight

Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Percentage change in body weight

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000192 OG00190

Title

Denominators

Categories

Title	Measurements
	OG000-14.4± 10.5 OG001-2.5± 7.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Treatment policy estimand	ANCOVA		<0.0001		Treatment difference	-11.43			2-Sided	95	-13.88	-8.98					Superiority	Week 64 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate.
OG000 OG001

Primary

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)

Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts

Secondary

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

Number of participants who achieved ≥ 10% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts

Secondary

Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)

Number of participants who achieved ≥ 15% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts

Secondary

Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)

Number of participants who achieved ≥ 20% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts

Secondary

Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT)

Change in physical function domain score IWQOL-Lite-CT from baseline (week 0) to the end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning. This outcome measure shows results for 'physical function domain'.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Score on a scale

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Secondary

Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)

Number of participants who achieved ≥14.6 in IWQOL-Lite-CT PFD score (Yes/No) from baseline to end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Secondary

Change in Body Weight - Kilogram (kg)

Change in body weight from baseline (week 0) to end of treatment (week 64) is presented.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

kg

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

Secondary

Change in Body Mass Index (BMI)

Change in BMI from baseline (week 0) to end of treatment (week 64) is presented.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Kilogram per square meter (kg/m^2)

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

Secondary

Change in Waist Circumference

Change in waist circumference from baseline (week 0) to end of treatment (week 64) is presented.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

centimeter (cm)

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

Secondary

Change in Systolic Blood Pressure

Change in systolic blood pressure from baseline (week 0) to end of treatment (week 64) is presented.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Millimeters of mercury (mmHg)

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

Secondary

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from randomisation (week 0) to end of treatment (week 64) is presented.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mmHg

Randomisation (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

Secondary

Change in Glycosylated Haemoglobin (HbA1c)

Change in HbA1c from baseline (week 0) to end of treatment (week 64) is presented.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

Secondary

Change in Total Cholesterol - Ratio to Baseline

Change in total cholesterol (measured in millimoles per liter [mmol/L]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of total cholesterol

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of HDL

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of LDL

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline

Change in VLDL cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of VLDL

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Change in Triglycerides - Ratio to Baseline

Change in triglycerides (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of triglycerides

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Change in Free Fatty Acids - Ratio to Baseline

Change in free fatty acids (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of free fatty acids

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

Change in high sensitivity C-Reactive Protein (hsCRP) (milligram per litre [mg/L]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of hsCRP

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Change in Fasting Plasma Glucose (FPG)

Change in FPG measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 64) is presented.

FAS comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mg/dL

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

Secondary

Change in Fasting Serum Insulin - Ratio to Baseline

Change in fasting serum insulin measured in picomoles per liter (pmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Ratio of fasting serum insulin

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)

Number of participants with BMI <30 at the end of treatment (week 64) from baseline (week 0) is presented. The outcome measure is applicable for participants with BMI ≥ 30 at baseline (week 0). In the reported data, 'Yes' infers the number of participants who have achieved BMI less than 30, whereas 'No' infers the number of participants who have not achieved BMI less than 30 at week 64.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

From baseline (week 0) to end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts

Secondary

Number of Participants With Change in Glycaemic Status

Number of participants with change in glycaemic status from baseline (week 0) to the end of treatment (week 64) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: 5.7% <= HbA1c < 6.5% 3) Type 2 diabetes: HbA1c >=6.5%.

FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed = participants evaluable at a specific time point.

Posted

Count of Participants

Participants

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts

Secondary

Number of Treatment Emergent Adverse Events (TEAEs)

Number of treatment emergent adverse events from baseline (week 0) to end of study (week 71) is presented. An adverse event (AE) is defined as 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.

SAS included all participants randomly assigned to study treatment and who took at least 1 dose of IMP. Participants were analysed according to the treatment they actually received.

Posted

Number

Events

From baseline (week 0) to end of study (week 71)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants

Secondary

Number of Serious Treatment Emergent Adverse Events

Number of treatment emergent serious adverse events from baseline (week 0) to end of study (week 71) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.

SAS included all participants randomly assigned to study treatment and who took at least 1 dose of IMP. Participants were analysed according to the treatment they actually received.

Posted

Number

Events

From baseline (week 0) to end of study (week 71)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts

Secondary

Change in Pulse

Change in pulse from baseline (week 0) to end of treatment (week 64) is presented.

SAS included all participants randomly assigned to study treatment and who took at least 1 dose of IMP. Participants were analysed according to the treatment they actually received. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Beats per minute (Beats/min)

Baseline (week 0), end of treatment (week 64)

ID	Title	Description
OG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
OG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.	0	205	8	204	172	204
EG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.	0	102	9	102	79	102

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute kidney injury	Renal and urinary disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
COVID-19	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Depression	Psychiatric disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Dysarthria	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Furuncle	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Headache	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Hypertension	Vascular disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Hypotension	Vascular disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0002 events1 affected204 at risk EG0010 events0 affected102 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Memory impairment	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Ovarian mass	Reproductive system and breast disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Pneumonia	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Sleeve gastrectomy	Surgical and medical procedures	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected102 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected102 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00016 events15 affected204 at risk EG0015 events4 affected102 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00023 events18 affected204 at risk EG0012 events2 affected102 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG00014 events13 affected204 at risk EG0012 events2 affected102 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0006 events6 affected204 at risk EG0019 events6 affected102 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0006 events6 affected204 at risk EG0016 events6 affected102 at risk
Bronchitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG00010 events9 affected204 at risk EG0018 events7 affected102 at risk
COVID-19	Infections and infestations	MedDRA 27	Systematic Assessment	EG00045 events41 affected204 at risk EG00119 events18 affected102 at risk
Constipation	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00059 events41 affected204 at risk EG00111 events10 affected102 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG00015 events14 affected204 at risk EG0011 events1 affected102 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00061 events36 affected204 at risk EG00110 events9 affected102 at risk
Dizziness	Nervous system disorders	MedDRA 27	Systematic Assessment	EG00014 events11 affected204 at risk EG0011 events1 affected102 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00050 events37 affected204 at risk EG00111 events9 affected102 at risk
Eructation	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00023 events21 affected204 at risk EG0012 events2 affected102 at risk
Fatigue	General disorders	MedDRA 27	Systematic Assessment	EG00015 events15 affected204 at risk EG0011 events1 affected102 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00017 events16 affected204 at risk EG0015 events5 affected102 at risk
Headache	Nervous system disorders	MedDRA 27	Systematic Assessment	EG00034 events24 affected204 at risk EG00110 events9 affected102 at risk
Influenza	Infections and infestations	MedDRA 27	Systematic Assessment	EG00021 events15 affected204 at risk EG00110 events10 affected102 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG00059 events43 affected204 at risk EG00140 events27 affected102 at risk
Nausea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG000157 events95 affected204 at risk EG00127 events19 affected102 at risk
Sinusitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0008 events7 affected204 at risk EG0018 events7 affected102 at risk
Tonsillitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0005 events5 affected204 at risk EG0017 events6 affected102 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG00011 events11 affected204 at risk EG00113 events9 affected102 at risk
Urinary tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG00016 events13 affected204 at risk EG0014 events3 affected102 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG000105 events63 affected204 at risk EG0016 events6 affected102 at risk

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Oral Semaglutide 25 mg	Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
BG001	Placebo	Participants received placebo matched to semaglutide orally once daily up to week 64.
BG002	Total	Total of all reporting groups