Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01720446 SUSTAIN™ 6 | Diabetes Mellitus, Type 2 | Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke Time from randomisation up to end of follow-up (scheduled at week 109) | Placebo | 8.9 percentage of subjects |
| Semaglutide | 6.6 percentage of subjects | |||
| NCT01885208 SUSTAIN™ 3 | Diabetes Mellitus, Type 2 | Change From Baseline in HbA1c (Glycosylated Haemoglobin) Week 0, week 56 | Exenatide ER 2.0 mg | -0.92 percentage of glycosylated haemoglobin (±0.06 Standard Error) |
| Semaglutide 1.0 mg | -1.54 percentage of glycosylated haemoglobin (±0.06 Standard Error) | |||
| NCT01930188 SUSTAIN™ 2 | Diabetes Mellitus, Type 2 | Change in HbA1c (Glycosylated Haemoglobin) From Baseline Week 0, week 56 | Semaglutide 0.5 mg + Sitagliptin Placebo | -1.32 percentage of glycosylated haemoglobin (±0.05 Standard Error) |
| Semaglutide 1.0 mg + Sitagliptin Placebo | -1.61 percentage of glycosylated haemoglobin (±0.05 Standard Error) | |||
| Sitagliptin + Semaglutide Placebo | -0.55 percentage of glycosylated haemoglobin (±0.05 Standard Error) | |||
| NCT02054897 SUSTAIN™1 | Diabetes Mellitus, Type 2 | Change in HbA1c (Glycosylated Haemoglobin) Week 0, week 30 | Placebo | -0.00 Percentage of HbA1c (±0.90 Standard Deviation) |
| Semaglutide 0.5 mg | -1.47 Percentage of HbA1c (±1.02 Standard Deviation) | |||
| Semaglutide 1.0 mg | -1.56 Percentage of HbA1c (±1.26 Standard Deviation) | |||
| NCT02128932 SUSTAIN™ 4 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline Week 0, week 30 | Insulin Glargine | -0.83 percentage (±0.05 Standard Error) |
| Semaglutide 0.5mg/Week | -1.21 percentage (±0.05 Standard Error) | |||
| Semaglutide 1.0 mg/Week | -1.64 percentage (±0.05 Standard Error) | |||
| NCT02207374 SUSTAIN™ | Diabetes Mellitus, Type 2 | Number of Treatment Emergent Adverse Events (TEAEs) Weeks 0-56 | Additional OAD | 269 Number of events |
| Semaglutide 0.5 mg | 909 Number of events | |||
| Semaglutide 1.0 mg | 954 Number of events | |||
| NCT02254291 SUSTAIN™ | Diabetes Mellitus, Type 2 | Number of Treatment Emergent Adverse Events (TEAEs) Weeks 0-30 | Semaglutide 0.5 mg | 228 Number of events |
| Semaglutide 1.0 mg | 197 Number of events | |||
| Sitagliptin | 186 Number of events | |||
| NCT02305381 SUSTAIN™ 5 | Diabetes Mellitus, Type 2 | Change in HbA1c (Glycosylated Haemoglobin) Week 0, week 30 | Placebo | -0.09 percentage of glycosylated hemoglobin (±0.09 Standard Error) |
| Semaglutide 0.5 mg | -1.45 percentage of glycosylated hemoglobin (±0.09 Standard Error) | |||
| Semaglutide 1.0 mg | -1.85 percentage of glycosylated hemoglobin (±0.09 Standard Error) | |||
| NCT02607865 PIONEER 3 | Diabetes Mellitus, Type 2 | Change in HbA1c: Week 26 Week 0, week 26 | Oral Semaglutide 14 mg | -1.4 Percentage of HbA1c (±1.0 Standard Deviation) |
| Oral Semaglutide 14 mg | -1.3 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.6 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.6 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.2 Percentage of HbA1c (±1.1 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.1 Percentage of HbA1c (±1.1 Standard Deviation) | |||
| Sitagliptin 100 mg | -0.8 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| Sitagliptin 100 mg | -0.8 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| NCT02648204 SUSTAIN 7 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 40 | Dulaglutide 0.75 mg | -1.11 percentage of HbA1c (±0.05 Standard Error) |
| Dulaglutide 1.5 mg | -1.37 percentage of HbA1c (±0.06 Standard Error) | |||
| Semaglutide 0.5 mg | -1.51 percentage of HbA1c (±0.06 Standard Error) | |||
| Semaglutide 1.0 mg | -1.78 percentage of HbA1c (±0.06 Standard Error) | |||
| NCT02692716 PIONEER 6 | Diabetes Mellitus, Type 2 | Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Oral Semaglutide | 61 Participants |
| Placebo | 76 Participants | |||
| NCT02827708 PIONEER 5 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 26 | Oral Semaglutide 14 mg | -1.1 Percentage of HbA1c (±1.0 Standard Deviation) |
| Oral Semaglutide 14 mg | -1.2 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| Placebo | -0.1 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| Placebo | -0.2 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| NCT02849080 PIONEER 7 | Diabetes Mellitus, Type 2 | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 52 | Oral Semaglutide Flex- Main Phase | 134 Participants |
| Oral Semaglutide Flex- Main Phase | 96 Participants | |||
| Oral Semaglutide Flex- Main Phase | 123 Participants | |||
| Oral Semaglutide Flex- Main Phase | 73 Participants | |||
| Sitagliptin 100 mg- Main Phase | 52 Participants | |||
| Sitagliptin 100 mg- Main Phase | 178 Participants | |||
| Sitagliptin 100 mg- Main Phase | 60 Participants | |||
| Sitagliptin 100 mg- Main Phase | 132 Participants | |||
| NCT02863328 PIONEER 2 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 26 | Empagliflozin 25 mg | -0.9 Percentage-point of HbA1c (±0.9 Standard Deviation) |
| Empagliflozin 25 mg | -0.9 Percentage-point of HbA1c (±0.9 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.3 Percentage-point of HbA1c (±1.1 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.5 Percentage-point of HbA1c (±1.1 Standard Deviation) | |||
| NCT02863419 PIONEER 4 | Diabetes Mellitus, Type 2 | Change in HbA1c (Week 26) Week 0, week 26 | Liraglutide 1.8 mg | -1.2 Percentage of HbA1c (±0.9 Standard Deviation) |
| Liraglutide 1.8 mg | -1.1 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.4 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.2 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| Placebo | -0.1 Percentage of HbA1c (±0.7 Standard Deviation) | |||
| Placebo | -0.1 Percentage of HbA1c (±0.7 Standard Deviation) | |||
| NCT02906930 PIONEER 1 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 26 | Oral Semaglutide 14 mg | -1.5 Percentage of HbA1c (±1.0 Standard Deviation) |
| Oral Semaglutide 14 mg | -1.6 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.9 Percentage of HbA1c (±1.2 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.9 Percentage of HbA1c (±1.2 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.3 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.4 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| Placebo | -0.3 Percentage of HbA1c (±1.2 Standard Deviation) | |||
| Placebo | -0.3 Percentage of HbA1c (±1.2 Standard Deviation) | |||
| NCT03015220 PIONEER 10 | Diabetes Mellitus, Type 2 | Number of Treatment-emergent Adverse Events (TEAEs) Weeks 0-57 | Dulaglutide 0.75 mg | 178 Events |
| Oral Semaglutide 14 mg | 324 Events | |||
| Oral Semaglutide 3 mg | 330 Events | |||
| Oral Semaglutide 7 mg | 350 Events | |||
| NCT03018028 PIONEER 9 | Diabetes Mellitus, Type 2 | Change in HbA1c (Week 26) Week 0, week 26 | Liraglutide 0.9 mg | -1.4 Percentage point of HbA1c (±1.1 Standard Deviation) |
| Liraglutide 0.9 mg | -1.4 Percentage point of HbA1c (±1.1 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.7 Percentage point of HbA1c (±0.9 Standard Deviation) | |||
| Oral Semaglutide 14 mg | -1.7 Percentage point of HbA1c (±0.8 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -1.1 Percentage point of HbA1c (±0.8 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -1.1 Percentage point of HbA1c (±0.8 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.7 Percentage point of HbA1c (±0.8 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.6 Percentage point of HbA1c (±0.8 Standard Deviation) | |||
| Placebo | -0.2 Percentage point of HbA1c (±0.7 Standard Deviation) | |||
| Placebo | -0.4 Percentage point of HbA1c (±1.0 Standard Deviation) | |||
| NCT03021187 PIONEER 8 | Diabetes Mellitus, Type 2 | Change in HbA1c (Week 26) Week 0, week 26 | Oral Semaglutide 14 mg | -1.4 Percentage of HbA1c (±0.9 Standard Deviation) |
| Oral Semaglutide 14 mg | -1.3 Percentage of HbA1c (±1.1 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.6 Percentage of HbA1c (±1.1 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.5 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.1 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.0 Percentage of HbA1c (±1.1 Standard Deviation) | |||
| Placebo | -0.1 Percentage of HbA1c (±0.8 Standard Deviation) | |||
| Placebo | -0.1 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| NCT03061214 SUSTAIN | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 30 | Semaglutide 0.5 mg | -1.5 Percentage of glycosylated haemoglobin (±1.1 Standard Deviation) |
| Semaglutide 0.5 mg | -1.5 Percentage of glycosylated haemoglobin (±1.1 Standard Deviation) | |||
| Semaglutide 1.0 mg | -1.8 Percentage of glycosylated haemoglobin (±0.9 Standard Deviation) | |||
| Semaglutide 1.0 mg | -1.7 Percentage of glycosylated haemoglobin (±1.0 Standard Deviation) | |||
| Sitagliptin | -0.9 Percentage of glycosylated haemoglobin (±0.9 Standard Deviation) | |||
| Sitagliptin | -1.0 Percentage of glycosylated haemoglobin (±0.9 Standard Deviation) | |||
| NCT03086330 SUSTAIN 9 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 30 | Placebo | -0.2 Percentage of HbA1c (±0.9 Standard Deviation) |
| Semaglutide 1.0 mg | -1.6 Percentage of HbA1c (±0.8 Standard Deviation) | |||
| NCT03136484 SUSTAIN 8 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 52 | Canagliflozin + Semaglutide Placebo | -1.0 Percentage (%) of HbA1c (±1.1 Standard Deviation) |
| Canagliflozin + Semaglutide Placebo | -1.0 Percentage (%) of HbA1c (±1.0 Standard Deviation) | |||
| Semaglutide + Canagliflozin Placebo | -1.7 Percentage (%) of HbA1c (±1.1 Standard Deviation) | |||
| Semaglutide + Canagliflozin Placebo | -1.5 Percentage (%) of HbA1c (±1.3 Standard Deviation) | |||
| NCT03191396 SUSTAIN 10 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 30 | Liraglutide 1.2 mg | -1.1 Percentage of glycosylated haemoglobin (±1.0 Standard Deviation) |
| Semaglutide 1.0 mg | -1.7 Percentage of glycosylated haemoglobin (±0.9 Standard Deviation) | |||
| NCT03548935 STEP 1 | Obesity | Change in Body Weight (%) Baseline (week 0) to week 68 | Placebo | -2.8 Percentage point (±6.5 Standard Deviation) |
| Placebo | -3.1 Percentage point (±6.4 Standard Deviation) | |||
| Semaglutide 2.4 mg | -16.9 Percentage point (±9.4 Standard Deviation) | |||
| Semaglutide 2.4 mg | -15.6 Percentage point (±10.1 Standard Deviation) | |||
| NCT03548935 STEP 1 | Obesity | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) After week 68 | Placebo | 182 Participants |
| Placebo | 334 Participants | |||
| Placebo | 395 Participants | |||
| Placebo | 165 Participants | |||
| Semaglutide 2.4 mg | 165 Participants | |||
| Semaglutide 2.4 mg | 978 Participants | |||
| Semaglutide 2.4 mg | 81 Participants | |||
| Semaglutide 2.4 mg | 1047 Participants | |||
| NCT03548987 STEP 4 | Obesity | Change From Randomisation to Week 68 in Body Weight (%) Randomisation (week 20) to week 68 | Placebo | 6.1 Percentage point (±7.7 Standard Deviation) |
| Placebo | 6.5 Percentage point (±7.7 Standard Deviation) | |||
| Semaglutide 2.4 mg | -8.8 Percentage point (±7.8 Standard Deviation) | |||
| Semaglutide 2.4 mg | -8.3 Percentage point (±8.1 Standard Deviation) | |||
| NCT03552757 STEP 2 | Obesity | Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo Baseline (week 0) to week 68 | Placebo | -3.3 Percentage point of body weight (±5.5 Standard Deviation) |
| Placebo | -3.1 Percentage point of body weight (±5.2 Standard Deviation) | |||
| Semaglutide 2.4 mg | -10.7 Percentage point of body weight (±7.8 Standard Deviation) | |||
| Semaglutide 2.4 mg | -9.9 Percentage point of body weight (±8.0 Standard Deviation) | |||
| NCT03552757 STEP 2 | Obesity | Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo At week 68 | Placebo | 107 Participants |
| Placebo | 269 Participants | |||
| Placebo | 94 Participants | |||
| Placebo | 246 Participants | |||
| Semaglutide 2.4 mg | 267 Participants | |||
| Semaglutide 2.4 mg | 121 Participants | |||
| Semaglutide 2.4 mg | 257 Participants | |||
| Semaglutide 2.4 mg | 94 Participants | |||
| NCT03574597 SELECT | Obesity | Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke From randomisation (week 0) up to 240 weeks | Placebo | 701 Participants |
| Semaglutide | 569 Participants | |||
| NCT03611582 STEP 3 | Obesity | Change in Body Weight (%) Baseline (week 0) to week 68 | Placebo | -6.1 Percentage (±7.6 Standard Deviation) |
| Placebo | -5.8 Percentage (±7.7 Standard Deviation) | |||
| Semaglutide 2.4 mg | -17.6 Percentage (±9.6 Standard Deviation) | |||
| Semaglutide 2.4 mg | -16.5 Percentage (±10.1 Standard Deviation) | |||
| NCT03611582 STEP 3 | Obesity | Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% After 68 weeks | Placebo | 82 Participants |
| Placebo | 90 Participants | |||
| Placebo | 82 Participants | |||
| Placebo | 99 Participants | |||
| Semaglutide 2.4 mg | 50 Participants | |||
| Semaglutide 2.4 mg | 34 Participants | |||
| Semaglutide 2.4 mg | 323 Participants | |||
| Semaglutide 2.4 mg | 300 Participants | |||
| NCT03689374 SUSTAIN 11 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycated Haemoglobin (HbA1c) Baseline (week 0), week 52 | Insulin Aspart | -1.2 Percentage of HbA1c (±1.0 Standard Deviation) |
| Semaglutide | -1.5 Percentage of HbA1c (±1.0 Standard Deviation) | |||
| NCT03693430 STEP 5 | Obesity | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% At Week 104 | Placebo | 44 Participants |
| Placebo | 84 Participants | |||
| Placebo | 38 Participants | |||
| Placebo | 71 Participants | |||
| Semaglutide 2.4 mg | 110 Participants | |||
| Semaglutide 2.4 mg | 111 Participants | |||
| Semaglutide 2.4 mg | 33 Participants | |||
| Semaglutide 2.4 mg | 22 Participants | |||
| NCT03693430 STEP 5 | Obesity | Percentage Change From Baseline (Week 0) to Week 104 in Body Weight From Baseline (Week 0) to Week 104 | Placebo | -1.9 percentage change (±8.9 Standard Deviation) |
| Placebo | -2.0 percentage change (±8.6 Standard Deviation) | |||
| Semaglutide 2.4 mg | -15.9 percentage change (±12.3 Standard Deviation) | |||
| Semaglutide 2.4 mg | -17.3 percentage change (±11.9 Standard Deviation) | |||
| NCT03811574 STEP 6 | Obesity | Change in Body Weight (%) Baseline (week 0), week 68 | Placebo | -1.9 Percentage change (±5.9 Standard Deviation) |
| Semaglutide 1.7 mg | -9.9 Percentage change (±7.8 Standard Deviation) | |||
| Semaglutide 2.4 mg | -13.4 Percentage change (±8.6 Standard Deviation) | |||
| NCT03811574 STEP 6 | Obesity | Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% At week 68 | Placebo | 21 Participants |
| Placebo | 79 Participants | |||
| Semaglutide 1.7 mg | 71 Participants | |||
| Semaglutide 1.7 mg | 27 Participants | |||
| Semaglutide 2.4 mg | 33 Participants | |||
| Semaglutide 2.4 mg | 160 Participants | |||
| NCT03819153 FLOW | Diabetes Mellitus, Type 2 | Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death From Week 0 up to Week 234 | Placebo | 410 Participants |
| Semaglutide | 331 Participants | |||
| NCT03914326 SOUL | Diabetes Mellitus, Type 2 | Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke From randomisation (week 0) up to week 265 | Oral Semaglutide | 579 Participants |
| Placebo | 668 Participants | |||
| NCT03919929 TEAL | Non-alcoholic Fatty Liver Disease | Change in Hepatic Fat Fraction Baseline and 12 weeks | Diet Intervention | -1.41 Change in percentage of liver fat (±2.24 Standard Deviation) |
| GLP-1 Intervention | -1.84 Change in percentage of liver fat (±4.39 Standard Deviation) | |||
| NCT03919929 TEAL | Non-alcoholic Fatty Liver Disease | Change in Weight Baseline and 12 weeks | Diet Intervention | -1.66 Change in weight (KG) (±2.81 Standard Deviation) |
| GLP-1 Intervention | -5.30 Change in weight (KG) (±4.92 Standard Deviation) | |||
| NCT03987919 SURPASS-2 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) Baseline, Week 40 | 1 mg Semaglutide | -1.86 Percentage of HbA1c (±0.048 Standard Error) |
| 10 mg Tirzepatide | -2.37 Percentage of HbA1c (±0.048 Standard Error) | |||
| 15 mg Tirzepatide | -2.46 Percentage of HbA1c (±0.048 Standard Error) | |||
| NCT03989232 SUSTAIN FORTE | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 40 | Semaglutide 1.0 mg | -1.9 Percentage change (±1.0 Standard Deviation) |
| Semaglutide 1.0 mg | -2.0 Percentage change (±1.0 Standard Deviation) | |||
| Semaglutide 2.0 mg | -2.2 Percentage change (±1.0 Standard Deviation) | |||
| Semaglutide 2.0 mg | -2.2 Percentage change (±1.1 Standard Deviation) | |||
| NCT04017832 PIONEER 12 | Diabetes Mellitus, Type 2 | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) From baseline to week 26 | Oral Semaglutide 14 mg | -1.5 Percentage point of HbA1C (±1.0 Standard Deviation) |
| Oral Semaglutide 14 mg | -1.6 Percentage point of HbA1C (±1.0 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.8 Percentage point of HbA1C (±1.0 Standard Deviation) | |||
| Oral Semaglutide 3 mg | -0.8 Percentage point of HbA1C (±1.0 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.3 Percentage point of HbA1C (±1.0 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.3 Percentage point of HbA1C (±1.0 Standard Deviation) | |||
| Sitagliptin 100 mg | -0.7 Percentage point of HbA1C (±1.0 Standard Deviation) | |||
| Sitagliptin 100 mg | -0.7 Percentage point of HbA1C (±1.0 Standard Deviation) | |||
| NCT04074161 STEP 8 | Obesity | Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg) Baseline (week 0), week 68 | Liraglutide 3.0 mg | -6.4 Percentage of body weight (±7.7 Standard Deviation) |
| Semaglutide 2.4 mg | -16.4 Percentage of body weight (±10.5 Standard Deviation) | |||
| NCT04102189 | Obesity | Change in Body Mass Index (BMI) (Percentage [%]) Baseline (week 0), week 68 | Placebo | -0.1 Percentage change of BMI (±8.6 Standard Deviation) |
| Semaglutide 2.4 mg | -16.2 Percentage change of BMI (±12.9 Standard Deviation) | |||
| NCT04109547 PIONEER 11 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycosylated Haemoglobin (HbA1c) Baseline (Week 0), Week 26 | Oral Semaglutide 14 mg | -1.6 Percentage of HbA1c (±1.0 Standard Deviation) |
| Oral Semaglutide 3 mg | -1.1 Percentage of HbA1c (±0.7 Standard Deviation) | |||
| Oral Semaglutide 7 mg | -1.5 Percentage of HbA1c (±0.8 Standard Deviation) | |||
| Placebo | -0.2 Percentage of HbA1c (±0.9 Standard Deviation) | |||
| NCT04251156 STEP7 | Diabetes Mellitus, Type 2 | Change From Baseline in Body Weight (Percentage [%]) Baseline (week 0), week 44 | Placebo | -3.6 Percentage change (±5.9 Standard Deviation) |
| Semaglutide 2.4 mg | -12.5 Percentage change (±7.4 Standard Deviation) | |||
| NCT04251156 STEP7 | Diabetes Mellitus, Type 2 | Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No) At week 44 | Placebo | 36 Participants |
| Placebo | 80 Participants | |||
| Semaglutide 2.4 mg | 203 Participants | |||
| Semaglutide 2.4 mg | 35 Participants | |||
| NCT04560998 STRIDE | Diabetes Mellitus, Type 2 | Change in Maximum Walking Distance on a Constant Load Treadmill Test Baseline (week 0), end of treatment (week 52) | Placebo | 1.08 Ratio of maximum walking distance |
| Semaglutide | 1.21 Ratio of maximum walking distance | |||
| NCT04707469 PIONEER PLUS | Diabetes Mellitus, Type 2 | Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) Baseline (week 0), week 52 | Oral Semaglutide 14 mg | -1.5 Percentage point of HbA1c (±1.3 Standard Deviation) |
| Oral Semaglutide 25 mg | -1.9 Percentage point of HbA1c (±1.3 Standard Deviation) | |||
| Oral Semaglutide 50 mg | -2.1 Percentage point of HbA1c (±1.4 Standard Deviation) | |||
| NCT04741074 RAISE-KT | Obesity | Kidney Transplant Eligibility Ascertained at the end of 9 months | Placebo | 2 Participants |
| Semaglutide | 3 Participants | |||
| NCT04788511 STEP-HFpEF | Obesity | Change in Body Weight From baseline (week 0) to end of treatment (week 52) | Placebo | -2.5 Percentage of body weight (±5.6 Standard Deviation) |
| Semaglutide 2.4 mg | -13.9 Percentage of body weight (±8.1 Standard Deviation) | |||
| NCT04788511 STEP-HFpEF | Obesity | Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) From baseline (week 0) to end of treatment (week 52) | Placebo | 10.3 Score on a scale (±17.3 Standard Deviation) |
| Semaglutide 2.4 mg | 16.8 Score on a scale (±17.9 Standard Deviation) | |||
| NCT04865770 REMODEL | Diabetes Mellitus, Type 2 | Change in Global Kidney Perfusion (MRI) Baseline (week 0), End of treatment (week 52) | Placebo | 1.01 Ratio of global kidney perfusion (±26.83 Geometric Coefficient of Variation) |
| Placebo | 0.98 Ratio of global kidney perfusion (±28.85 Geometric Coefficient of Variation) | |||
| Placebo | 0.99 Ratio of global kidney perfusion (±24.39 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.03 Ratio of global kidney perfusion (±26.43 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.02 Ratio of global kidney perfusion (±29.25 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.04 Ratio of global kidney perfusion (±27.84 Geometric Coefficient of Variation) | |||
| NCT04865770 REMODEL | Diabetes Mellitus, Type 2 | Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI) Baseline (week 0), End of treatment (week 52) | Placebo | 1.01 Ratio of kidney inflammation (cortex) (±5.43 Geometric Coefficient of Variation) |
| Placebo | 1.01 Ratio of kidney inflammation (cortex) (±5.71 Geometric Coefficient of Variation) | |||
| Placebo | 1.01 Ratio of kidney inflammation (cortex) (±5.57 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.01 Ratio of kidney inflammation (cortex) (±3.93 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.01 Ratio of kidney inflammation (cortex) (±3.88 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.01 Ratio of kidney inflammation (cortex) (±3.78 Geometric Coefficient of Variation) | |||
| NCT04865770 REMODEL | Diabetes Mellitus, Type 2 | Change in Kidney Inflammation (Medulla), T1 Mapping (MRI) Baseline (week 0), End of treatment (week 52) | Placebo | 1.00 Ratio of kidney inflammation (medulla) (±5.91 Geometric Coefficient of Variation) |
| Placebo | 1.00 Ratio of kidney inflammation (medulla) (±5.13 Geometric Coefficient of Variation) | |||
| Placebo | 1.01 Ratio of kidney inflammation (medulla) (±4.85 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.00 Ratio of kidney inflammation (medulla) (±3.56 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.00 Ratio of kidney inflammation (medulla) (±3.90 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 1.00 Ratio of kidney inflammation (medulla) (±3.69 Geometric Coefficient of Variation) | |||
| NCT04865770 REMODEL | Diabetes Mellitus, Type 2 | Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*) Baseline (week 0), End of treatment (week 52) | Placebo | 1.00 Ratio of kidney oxygenation (cortex) (±7.39 Geometric Coefficient of Variation) |
| Placebo | 1.01 Ratio of kidney oxygenation (cortex) (±9.12 Geometric Coefficient of Variation) | |||
| Placebo | 0.99 Ratio of kidney oxygenation (cortex) (±7.26 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 0.98 Ratio of kidney oxygenation (cortex) (±5.35 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 0.98 Ratio of kidney oxygenation (cortex) (±7.51 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 0.98 Ratio of kidney oxygenation (cortex) (±5.65 Geometric Coefficient of Variation) | |||
| NCT04865770 REMODEL | Diabetes Mellitus, Type 2 | Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*) Baseline (week 0), End of treatment (week 52) | Placebo | 1.01 Ratio of kidney oxygenation (medulla) (±11.37 Geometric Coefficient of Variation) |
| Placebo | 1.02 Ratio of kidney oxygenation (medulla) (±13.02 Geometric Coefficient of Variation) | |||
| Placebo | 1.02 Ratio of kidney oxygenation (medulla) (±10.83 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 0.99 Ratio of kidney oxygenation (medulla) (±10.25 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 0.99 Ratio of kidney oxygenation (medulla) (±8.97 Geometric Coefficient of Variation) | |||
| Semaglutide 1.0 mg | 0.98 Ratio of kidney oxygenation (medulla) (±10.09 Geometric Coefficient of Variation) | |||
| NCT04998136 | Obesity | Change in Body Weight (%) : In-trial Observation Period Baseline (week 0), end of treatment (week 44) | Placebo | -2.6 Percentage of body weight (±5.8 Standard Deviation) |
| Semaglutide | -16.4 Percentage of body weight (±7.3 Standard Deviation) | |||
| NCT04998136 | Obesity | Change in Body Weight (%) : On-treatment Observation Period Baseline (week 0), end of treatment (week 44) | Placebo | -2.7 Percentage of body weight (±5.8 Standard Deviation) |
| Semaglutide | -16.4 Percentage of body weight (±7.4 Standard Deviation) | |||
| NCT04998136 | Obesity | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period At week 44 | Placebo | 12 Participants |
| Placebo | 36 Participants | |||
| Semaglutide | 4 Participants | |||
| Semaglutide | 96 Participants | |||
| NCT04998136 | Obesity | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period At week 44 | Placebo | 35 Participants |
| Placebo | 12 Participants | |||
| Semaglutide | 92 Participants | |||
| Semaglutide | 4 Participants | |||
| NCT05035095 OASIS 1 | Obesity | Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No) At end-of-treatment (week 68) | Oral Semaglutide 50 mg | 48 Participants |
| Oral Semaglutide 50 mg | 269 Participants | |||
| Placebo | 76 Participants | |||
| Placebo | 219 Participants | |||
| NCT05035095 OASIS 1 | Obesity | Percentage Change in Body Weight Baseline (week 0), end-of-treatment (week 68) | Oral Semaglutide 50 mg | -15.8 Percentage (%) change in body weight (±10.3 Standard Deviation) |
| Placebo | -2.2 Percentage (%) change in body weight (±7.2 Standard Deviation) | |||
| NCT05040971 STEP 10 | Obesity | Change in Body Weight (Percentage [%]) From randomisation (week 0) to end of treatment (week 52) | Placebo | -2.7 Percentage (%) of body weight (±4.3 Standard Deviation) |
| Semaglutide 2.4 mg | -14.4 Percentage (%) of body weight (±7.9 Standard Deviation) | |||
| NCT05040971 STEP 10 | Obesity | Participants With Change to Normoglycemia At week 52 | Placebo | 53 Participants |
| Placebo | 9 Participants | |||
| Placebo | 2 Participants | |||
| Semaglutide 2.4 mg | 23 Participants | |||
| Semaglutide 2.4 mg | 103 Participants | |||
| Semaglutide 2.4 mg | 1 Participants | |||
| NCT05064735 | Obesity | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Baseline (week 0), end of treatment (week 68) | Placebo | -26.2 Score on a scale (±25.0 Standard Deviation) |
| Semaglutide 2.4 mg | -43.7 Score on a scale (±25.3 Standard Deviation) | |||
| NCT05064735 | Obesity | Percentage Change in Body Weight Baseline (week 0), end of treatment (week 68) | Placebo | -2.5 Percentage change in body weight (±5.6 Standard Deviation) |
| Semaglutide 2.4 mg | -14.2 Percentage change in body weight (±8.6 Standard Deviation) | |||
| NCT05259033 COMBINE 2 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycosylated Haemoglobin (HbA1c) Baseline (week 0), (week 52) | IcoSema | -1.40 Percentage point of HbA1c (±0.91 Standard Deviation) |
| Semaglutide | -0.86 Percentage point of HbA1c (±0.96 Standard Deviation) | |||
| NCT05478252 | Diabetes Mellitus, Type 2 | Change in Glycosylated Haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 28) | Semaglutide B | -1.6 Percentage of glycosylated haemoglobin (±1.0 Standard Deviation) |
| Semaglutide J | -1.7 Percentage of glycosylated haemoglobin (±1.0 Standard Deviation) | |||
| NCT05564117 OASIS 4 | Obesity | Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No) At end of treatment (week 64) | Oral Semaglutide 25 mg | 40 Participants |
| Oral Semaglutide 25 mg | 152 Participants | |||
| Placebo | 62 Participants | |||
| Placebo | 28 Participants | |||
| NCT05564117 OASIS 4 | Obesity | Percentage Change in Body Weight Baseline (week 0), end of treatment (week 64) | Oral Semaglutide 25 mg | -14.4 Percentage change in body weight (±10.5 Standard Deviation) |
| Placebo | -2.5 Percentage change in body weight (±7.9 Standard Deviation) | |||
| NCT05646706 STEP UP | Obesity | Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) At week 72 | Placebo | 108 Participants |
| Placebo | 63 Participants | |||
| Semaglutide 7.2 mg | 862 Participants | |||
| Semaglutide 7.2 mg | 88 Participants | |||
| NCT05646706 STEP UP | Obesity | Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight Baseline (week 0), End of treatment (week 72) | Placebo | -3.8 Percentage (%) change in body weight (±7.1 Standard Deviation) |
| Semaglutide 7.2 mg | -19.5 Percentage (%) change in body weight (±10.6 Standard Deviation) | |||
| NCT05649137 | Diabetes Mellitus, Type 2 | Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) At week 72 | Placebo | 62 Participants |
| Placebo | 33 Participants | |||
| Semaglutide 2.4 mg | 24 Participants | |||
| Semaglutide 2.4 mg | 73 Participants | |||
| Semaglutide 7.2 mg | 251 Participants | |||
| Semaglutide 7.2 mg | 40 Participants | |||
| NCT05649137 | Diabetes Mellitus, Type 2 | Relative Change in Body Weight Baseline (week 0), End of treatment (week 72) | Placebo | -4.0 Percentage (%) change in body weight (±6.2 Standard Deviation) |
| Semaglutide 2.4 mg | -10.7 Percentage (%) change in body weight (±8.1 Standard Deviation) | |||
| Semaglutide 7.2 mg | -13.5 Percentage (%) change in body weight (±8.7 Standard Deviation) | |||
| NCT05788965 | Cystic Fibrosis | BMI (kg/m2) 12 weeks | Semaglutide Treatment | -1.8 kg/m2 (±0.9 Standard Deviation) |
| NCT05788965 | Cystic Fibrosis | Weight 12 weeks | Semaglutide Treatment | -4.6 kilograms (±1.9 Standard Deviation) |
| NCT05822830 SURMOUNT-5 | Obesity | Percent Change From Baseline in Body Weight Baseline, Week 72 | 15 mg or MTD - Tirzepatide | -20.2 Percent change (±0.59 Standard Error) |
| 2.4 mg or MTD - Semaglutide | -13.7 Percent change (±0.59 Standard Error) | |||
| NCT05891496 | Alzheimer Disease | Change in Gene Expression Assessed by scRNAseq (Cells in Blood) Baseline (week 0), week 12 | Placebo | 16.50 Differentially expressed genes (±15.86 Standard Deviation) |
| Semaglutide | 10.00 Differentially expressed genes (±5.97 Standard Deviation) | |||
| NCT05891496 | Alzheimer Disease | Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF]) Baseline (week 0), week 12 | Placebo | 21.00 Differentially expressed genes (±25.70 Standard Deviation) |
| Semaglutide | 41.25 Differentially expressed genes (±29.68 Standard Deviation) |