A Phase 3 interventional study of Oral semaglutide and Placebo (semaglutide) in Obesity and Overweight, sponsored by Novo Nordisk A/S. Completed at 56 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.
This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.
Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.
Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning
In addition to taking the medicine, participants will have talks with study staff about:
Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 667 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m\^2
Exclusion Criteria:
Participants will receive once daily semaglutide tables in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68)
Drug: Oral semaglutide
All participants are given once daily dose for 68 weeks
Drug: Placebo (semaglutide)
Participants will receive a daily dose of oral semaglutide.
Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.
Percentage Change in Body Weight
Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: At end-of-treatment (week 68)
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.
Time frame: At end-of-treatment (week 68)
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.
Time frame: At end-of-treatment (week 68)
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.
Time frame: At end-of-treatment (week 68)
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
Change in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
Change in Fasting Plasma Glucose (FPG)
Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: From baseline (week 0) to end-of-study (week 75)
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.
Time frame: From baseline (week 0) to end-of-study (week 75)
Change in Body Weight - Kilogram (Kg)
Change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: At end-of-treatment (week 68)
Change in Pulse
Change in pulse from baseline (week 0) to end-of-study (week 68) is presented.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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%.
Time frame: Baseline (week 0), end-of-treatment (week 68)
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.
Time frame: At end-of-treatment (week 68)
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.
Time frame: From baseline (week 0) to end-of-treatment (week 68)
The trial was conducted at 50 sites in 9 countries as follows: Canada (5 sites), Denmark (3 sites), Finland (3 sites), France (5 sites), Germany (7 sites), Japan (3 sites), Poland (5 sites), Russia (8 sites) and United States (11 sites).
| Milestone | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Started | 334 | 333 |
| Full analysis set | 334 | 333 |
| Safety analysis set | 334 | 333 |
| Completed | 320 | 307 |
| Not completed | 14 | 26 |
| Withdrew: Withdrawal by subject | 10 | 11 |
| Withdrew: Lost to follow-up | 4 | 14 |
| Withdrew: Physician decision | 0 | 1 |
Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
| Percentage (%) change in body weight | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Percentage Change in Body Weight | -15.8 ± 10.3 | -2.2 ± 7.2 |
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.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Yes | 269 | 76 |
| No | 48 | 219 |
Number of participants who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Yes | 220 | 35 |
| No | 97 | 260 |
Number of participants who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Yes | 170 | 17 |
| No | 147 | 278 |
Number of participants who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Yes | 107 | 8 |
| No | 210 | 287 |
Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented.
| centimeter (cm) | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Waist Circumference | -13.4 ± 10.0 | -2.8 ± 7.3 |
Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented.
| Kilogram per meter square (kg/m^2) | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Body Mass Index (BMI) | -5.9 ± 4.0 | -0.9 ± 2.8 |
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.
| Score on a scale | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function | 14.5 ± 20.2 | 5.0 ± 19.9 |
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.
| Score on a scale | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain | 2.4 ± 5.7 | -0.0 ± 5.4 |
Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
| Millimeter of mercury (mmHg) | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Systolic Blood Pressure | -7 ± 14 | -1 ± 14 |
Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
| Millimeter of mercury (mmHg) | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Diastolic Blood Pressure | -2 ± 9 | -1 ± 10 |
Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented.
| Percentage of HbA1c | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | -0.2 ± 0.3 | 0.1 ± 0.3 |
Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented.
| Milligrams per deciliter (mg/dL) | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | -10.3 ± 12.7 | -1.8 ± 10.4 |
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.
| Ratio of fasting serum insulin | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline | 0.67 ± 71.4 | 0.94 ± 55.3 |
Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
| Ratio of total cholesterol | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Total Cholesterol (mg/dL) - Ratio to Baseline | 0.97 ± 17.1 | 1.01 ± 16.6 |
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.
| Ratio of HDL cholesterol | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | 1.05 ± 16.6 | 1.01 ± 15.9 |
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.
| Ratio of LDL cholesterol | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline | 0.98 ± 25.8 | 1.03 ± 26.7 |
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.
| Ratio of VLDL cholesterol | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline | 0.77 ± 38.3 | 0.96 ± 37.2 |
Change in triglycerides (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
| Ratio of triglycerides | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Triglycerides (mg/dL) - Ratio to Baseline | 0.77 ± 38.4 | 0.96 ± 37.5 |
Change in free fatty acids (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
| Ratio of free fatty acids | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Free Fatty Acids (mg/dL) - Ratio to Baseline | 0.87 ± 71.7 | 1.00 ± 80.2 |
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.
| Ratio of hsCRP | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline | 0.42 ± 129.9 | 0.85 ± 117.9 |
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.
| Events | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Number of Treatment Emergent Adverse Events | 2500 | 1577 |
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.
| Events | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Number of Serious Adverse Events | 44 | 48 |
Change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
| Kilogram (kg) | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Body Weight - Kilogram (Kg) | -16.1 ± 10.9 | -2.4 ± 7.9 |
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.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Yes | 129 | 19 |
| No | 165 | 249 |
Change in pulse from baseline (week 0) to end-of-study (week 68) is presented.
| Beats/min | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Change in Pulse | 4 ± 9 | -0 ± 8 |
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%.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Baseline (week 0) — normo-glycaemia | 200 | 200 |
| Baseline (week 0) — pre-diabetes | 132 | 130 |
| Baseline (week 0) — type 2 diabetes | 2 | 3 |
| week 68 — normo-glycaemia | 274 | 139 |
| week 68 — pre-diabetes | 36 | 143 |
| week 68 — type 2 diabetes | 1 | 4 |
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.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Yes | 149 | 87 |
| No | 149 | 191 |
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.
| Participants | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| Yes | 113 | 56 |
| No | 190 | 224 |
Collected over From baseline (week 0) to end-of-study (week 75). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Semaglutide 50 mg | 0/334 (0%) | 32/334 (9.6%) | 292/334 (87.4%) |
| Placebo | 0/333 (0%) | 29/333 (8.7%) | 242/333 (72.7%) |
| Event | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/334 | 4/333 |
| CholelithiasisHepatobiliary disorders | 4/334 | 0/333 |
| Acute myocardial infarctionCardiac disorders | 0/334 | 2/333 |
| ArthritisMusculoskeletal and connective tissue disorders | 0/334 | 2/333 |
| Urinary tract infectionInfections and infestations | 0/334 | 2/333 |
| COVID-19 pneumoniaInfections and infestations | 2/334 | 0/333 |
| Adjustment disorder with depressed moodPsychiatric disorders | 0/334 | 1/333 |
| Angina pectorisCardiac disorders | 0/334 | 1/333 |
| AppendicitisInfections and infestations | 1/334 | 1/333 |
| COVID-19Infections and infestations | 1/334 | 1/333 |
| Event | Oral Semaglutide 50 mg | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 173/334 | 51/333 |
| COVID-19Infections and infestations | 119/334 | 115/333 |
| ConstipationGastrointestinal disorders | 92/334 | 50/333 |
| DiarrhoeaGastrointestinal disorders | 89/334 | 56/333 |
| VomitingGastrointestinal disorders | 80/334 | 12/333 |
| Decreased appetiteMetabolism and nutrition disorders | 56/334 | 24/333 |
| NasopharyngitisInfections and infestations | 38/334 | 49/333 |
| DyspepsiaGastrointestinal disorders | 47/334 | 17/333 |
| HeadacheNervous system disorders | 46/334 | 29/333 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 22/334 | 38/333 |
Full analysis set (FAS): All participants randomised according to the randomised treatment.
| Age, Continuous(Years) | Oral Semaglutide 50 mg | Placebo | Total |
|---|---|---|---|
| Mean | 49 ± 13 | 50 ± 12 | 50 ± 13 |
| Sex: Female, Male(Participants) | Oral Semaglutide 50 mg | Placebo | Total |
|---|---|---|---|
| Female | 247 | 238 | 485 |
| Male | 87 | 95 | 182 |
| Ethnicity (NIH/OMB)(Participants) | Oral Semaglutide 50 mg | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 13 | 27 |
| Not Hispanic or Latino | 288 | 296 | 584 |
| Unknown or Not Reported | 32 | 24 | 56 |
| Race/Ethnicity, Customized(Participants) | Oral Semaglutide 50 mg | Placebo | Total |
|---|---|---|---|
| White | 246 | 248 | 494 |
| Black or African American | 21 | 22 | 43 |
| Asian | 36 | 36 | 72 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Other | 1 | 3 | 4 |
| Not Reported | 28 | 23 | 51 |
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Plan to share: Yes — "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S