| Primary | Percentage Change in Body Weight | Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented. | Full analysis set (FAS) included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Percentage (%) change in body weight | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-15.8± 10.3
- OG001-2.2± 7.2
|
|
| | 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 |
|---|
| Treatment policy estimand | ANCOVA | | <0.0001 | | Treatment difference | -12.74 | | | 2-Sided | 95 | -14.15 | -11.33 | | | | | Superiority | Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate. | | |
|
| Primary | Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No) | Number of participants who achieved weight loss greater than or equal to 5% of their baseline body weight (yes/no) at end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | At end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No) | Number of participants who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | At end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No) | Number of participants who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | At end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No) | Number of participants who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | At end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Waist Circumference | Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | centimeter (cm) | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Body Mass Index (BMI) | Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Kilogram per meter square (kg/m^2) | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function | The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo |
|
| Secondary | Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain | Change in SF-36 v2.0 physical functioning domain from baseline (week 0) to end of treatment (week 68) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 (indicates population mean) with a SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. A positive change score indicates an improvement since baseline. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | |
|
| Secondary | Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Millimeter of mercury (mmHg) | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Millimeter of mercury (mmHg) | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) | Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline | Change in fasting serum insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to end-of-treatment (week 68) is presented as ratio to baseline. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting serum insulin | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Total Cholesterol (mg/dL) - Ratio to Baseline | Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | Change in high density lipoprotein (HDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL cholesterol | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline | Change in low density lipoprotein (LDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL cholesterol | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline | Change in very low density lipoprotein (VLDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of VLDL cholesterol | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Triglycerides (mg/dL) - Ratio to Baseline | Change in triglycerides (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Free Fatty Acids (mg/dL) - Ratio to Baseline | Change in free fatty acids (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of free fatty acids | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline | Change in high sensitivity C-reactive protein (measured in Milligrams per liter (mg/L)) from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of hsCRP | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Treatment Emergent Adverse Events | Number of treatment emergent adverse events from baseline (week 0) to end-of-study (week 75) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period. It is the time period in which participant was considered exposed to trial product. | SAS included All participants randomly assigned to study treatment and who took at least 1 dose of trial product. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Number | | Events | | From baseline (week 0) to end-of-study (week 75) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Serious Adverse Events | Number of serious adverse events from baseline (week 0) to end-of-study (week 75) is presented. A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or important medical event. | SAS included All participants randomly assigned to study treatment and who took at least 1 dose of trial product. | Posted | | Number | | Events | | From baseline (week 0) to end-of-study (week 75) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Body Weight - Kilogram (Kg) | Change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Kilogram (kg) | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Participants With Body Mass Index (BMI) Greater Than or Equal (≥) 30 at Baseline and BMI Lesser Than (<) 30 at Week 68 (Yes/no) | Number of participants who's body mass index (BMI) greater than or equal (≥) 30 at baseline and BMI lesser than (<) 30 at week 68 (yes/no) from (week 0) to end-of-treatment (week 68) is presented. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | At end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Change in Pulse | Change in pulse from baseline (week 0) to end-of-study (week 68) is presented. | SAS included All participants randomly assigned to study treatment and who took at least 1 dose of trial product. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Mean | Standard Deviation | Beats/min | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes) | Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and end-of-treatment (week 68) are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) less than (<) 5.7%; 2) Pre-diabetes: HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: HbA1c greater than or equal to (>=) 6.5%. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | Baseline (week 0), end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks. |
| |
| Secondary | Number of Participants With Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain (PFD) Greater Than or Equal (≥) 14.6 (Yes/No) | The IWQOL-Lite-CT (measured as score on a scale) is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | At end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 |
|
| Secondary | Number of Participants With Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Score Greater Than or Equal (≥) 3.7 (Yes/No) | Number of participants with change in SF-36 v2.0 physical functioning score ≥ 3.7 (yes/no) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). A positive change score indicates an improvement since baseline. The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. | FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data. | Posted | | Count of Participants | | Participants | | From baseline (week 0) to end-of-treatment (week 68) | | | | ID | Title | Description |
|---|
| OG000 | Oral Semaglutide 50 mg | Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68). | | OG001 | Placebo | |
|