18 and older, any sex, with Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Body Weight (%)Primary· Baseline (week 0) to week 68
Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Tem
In-trial observation period
Group
Value
95% CI
Semaglutide 2.4 mg
-16.5
± 10.1
Placebo
-5.8
± 7.7
On-treatment observation period
Group
Value
95% CI
Semaglutide 2.4 mg
-17.6
± 9.6
Placebo
-6.1
± 7.6
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%Primary· After 68 weeks
Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time i
In-trial observation period
Group
Value
95% CI
Semaglutide 2.4 mg
323
Placebo
90
Semaglutide 2.4 mg
50
Placebo
99
On-treatment observation period
Group
Value
95% CI
Semaglutide 2.4 mg
300
Placebo
82
Semaglutide 2.4 mg
34
Placebo
82
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%Secondary· After 68 weeks
Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Yes
Group
Value
95% CI
Semaglutide 2.4 mg
281
Placebo
51
No
Group
Value
95% CI
Semaglutide 2.4 mg
92
Placebo
138
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%Secondary· After 68 weeks
Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Yes
Group
Value
95% CI
Semaglutide 2.4 mg
208
Placebo
25
No
Group
Value
95% CI
Semaglutide 2.4 mg
165
Placebo
164
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%Secondary· After 68 weeks
Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Yes
Group
Value
95% CI
Semaglutide 2.4 mg
133
Placebo
7
No
Group
Value
95% CI
Semaglutide 2.4 mg
240
Placebo
182
Change in Waist CircumferenceSecondary· Baseline (week 0) to week 68
Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Group
Value
95% CI
Semaglutide 2.4 mg
-15.2
± 10.2
Placebo
-6.1
± 8.6
Change in Systolic Blood PressureSecondary· Baseline (week 0) to week 68
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Group
Value
95% CI
Semaglutide 2.4 mg
-6
± 14
Placebo
-2
± 15
Change in Short Form-36 (SF-36) - Physical Functioning ScoreSecondary· Baseline (week 0) to week 68
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard devi
Change in physical functioning score (SF-36)
Group
Value
95% CI
Semaglutide 2.4 mg
2.5
± 5.7
Placebo
1.7
± 5.7
Change in SF-36: Role-Physical score
Group
Value
95% CI
Semaglutide 2.4 mg
1.6
± 6.5
Placebo
1.5
± 6.7
Change in SF-36: Bodily Pain score
Group
Value
95% CI
Semaglutide 2.4 mg
1.3
± 7.1
Placebo
0.6
± 8.3
Change in SF-36: General Health score
Group
Value
95% CI
Semaglutide 2.4 mg
3.4
± 6.6
Placebo
1.9
± 6.4
Change in SF-36: Vitality score
Group
Value
95% CI
Semaglutide 2.4 mg
2.0
± 8.2
Placebo
0.9
± 7.8
Change in SF-36: Social Functioning score
Group
Value
95% CI
Semaglutide 2.4 mg
0.1
± 6.6
Placebo
-1.2
± 8.0
Change in SF-36: Mental Health score
Group
Value
95% CI
Semaglutide 2.4 mg
-0.5
± 6.0
Placebo
-1.5
± 7.1
Change in SF-36: Physical component summary
Group
Value
95% CI
Semaglutide 2.4 mg
3.2
± 6.0
Placebo
2.6
± 6.5
Change in Body Weight (Kg)Secondary· Baseline (week 0) to week 68
Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Group
Value
95% CI
Semaglutide 2.4 mg
-17.5
± 11.4
Placebo
-6.2
± 8.6
Change in Body Mass IndexSecondary· Baseline (week 0) to week 68
Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Group
Value
95% CI
Semaglutide 2.4 mg
-6.2
± 4.0
Placebo
-2.2
± 3.1
Change in HbA1c (%)Secondary· Baseline (week 0) to week 68
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Group
Value
95% CI
Semaglutide 2.4 mg
-0.5
± 0.3
Placebo
-0.3
± 0.2
Change in HbA1c (mmol/Mol)Secondary· Baseline (week 0) to week 68
Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Group
Value
95% CI
Semaglutide 2.4 mg
-5.8
± 3.1
Placebo
-3.1
± 2.5
Adverse events — posted to ClinicalTrials.gov
Time frame: week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Semaglutide 2.4 mg
Serious: 37/407 (9%)
Deaths: 0/407
Placebo
Serious: 6/204 (3%)
Deaths: 0/204
Serious adverse events (46 terms)
Reaction
System
Semaglutide 2.4 mg
Placebo
Cholelithiasis
Hepatobiliary disorders
—
—
Appendicitis
Infections and infestations
—
—
Cholecystitis acute
Hepatobiliary disorders
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
—
—
Cholecystitis
Hepatobiliary disorders
—
—
Abdominal abscess
Infections and infestations
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Anxiety
Psychiatric disorders
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Biliary dyskinesia
Hepatobiliary disorders
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Castleman's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Cellulitis
Infections and infestations
—
—
Cerebral infarction
Nervous system disorders
—
—
Deep vein thrombosis
Vascular disorders
—
—
Gastroenteritis viral
Infections and infestations
—
—
Haemorrhoids thrombosed
Gastrointestinal disorders
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
Hydronephrosis
Renal and urinary disorders
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
Incarcerated inguinal hernia
Gastrointestinal disorders
—
—
Inguinal hernia
Gastrointestinal disorders
—
—
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
—
—
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other Novo Nordisk A/S trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 11 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03611582.