Oral peptide GLP-1 receptor agonist
Semaglutide tablet
SEMA_PO
Doses in this pooled treatment
- Semaglutide 14 mg oral once daily (original tablet)
- Semaglutide 20 mg tablet once daily
- Semaglutide 40 mg tablet once daily
- Semaglutide 3 mg oral once daily (original tablet)
- Semaglutide 7 mg oral once daily (original tablet)
- Semaglutide oral once daily (original tablet), flexible dose: 3, 7 or 14 mg adjusted by HbA1c and tolerability
- Semaglutide 50 mg oral once daily (higher dose oral program)
Effects across outcomes
Bayesian random effects estimate against the comparator of each analysis (usually placebo), posterior median and 95% credible interval. Green: clearly better; red: clearly worse.
| Condition | Outcome | Window | Versus | Effect (95% CrI) | SUCRA |
|---|---|---|---|---|---|
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -1.10 (-1.43 to -0.74) | 0.70 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.79 (-1.31 to -0.23) | 0.46 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -0.22 (-1.49 to 1.26) | 0.47 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -1.26 (-1.83 to -0.24) | 0.59 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -1.08 (-1.57 to -0.41) | 0.80 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.92 (-1.42 to -0.34) | 0.67 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -3.15 (-5.21 to -1.18) | 0.93 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -1.16 (-1.51 to -0.81) | 0.84 |
| Type 2 diabetes (adults) | HbA1c change | weeks 36 to 64 (target week 52) | Placebo | MD -1.32 (-2.10 to -0.09) | 0.70 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -2.91 (-4.02 to -1.87) | 0.79 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -1.67 (-7.64 to 5.06) | 0.59 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -3.37 (-5.73 to -0.63) | 0.75 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -3.60 (-6.81 to 0.28) | 0.62 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -0.29 (-4.00 to 5.18) | 0.42 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -3.26 (-5.80 to -0.34) | 0.82 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 36 to 64 (target week 52) | Placebo | MD -0.18 (-4.52 to 4.84) | 0.69 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -1.20 (-3.46 to 0.85) | 0.90 |
| Type 2 diabetes (adults) | Body weight change in kilograms (diabetes) | weeks 20 to 36 (target week 26) | Placebo | MD -0.73 (-3.80 to 2.30) | 0.77 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 10.57 (3.78 to 21.20) | 0.66 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 7.36 (1.89 to 17.92) | 0.86 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 6.16 (1.32 to 16.74) | 0.81 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 8.93 (1.80 to 22.76) | 0.77 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 20 to 36 (target week 26) | Placebo | OR 8.29 (2.24 to 25.25) | 0.53 |
| Type 2 diabetes (adults) | HbA1c below 7 percent | weeks 36 to 64 (target week 52) | Placebo | OR 9.07 (1.55 to 34.45) | 0.86 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.07 (0.00 to 2.29) | 0.71 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.87 (0.28 to 2.72) | 0.73 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.99 (0.49 to 1.99) | 0.51 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -2.54 (-4.19 to -0.97) | 0.64 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -1.39 (-4.20 to 1.86) | 0.70 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -1.45 (-6.62 to 2.99) | 0.44 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -2.92 (-10.65 to 5.69) | 0.65 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 36 to 64 (target week 52) | Placebo | MD -4.72 (-17.81 to 9.39) | 0.70 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -0.87 (-4.46 to 2.69) | 0.63 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -1.94 (-12.54 to 9.00) | 0.58 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -4.74 (-10.81 to 1.16) | 0.64 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 64 to 130 (target week 104) | Placebo | MD -3.01 (-14.81 to 9.22) | 0.71 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 40 to 104 (target week 68) | Placebo | MD -3.91 (-7.64 to -0.00) | 0.94 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -4.25 (-8.41 to 0.45) | 0.92 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -1.62 (-9.89 to 7.09) | 0.57 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -1.65 (-8.48 to 5.01) | 0.61 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -1.05 (-4.89 to 2.94) | 0.85 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 11.44 (3.34 to 30.18) | 0.83 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 6.07 (1.90 to 15.40) | 0.98 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 7.14 (1.72 to 18.86) | 0.96 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 5.14 (1.93 to 11.19) | 0.98 |
| Type 2 diabetes (adults) | Weight loss of 5 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 2.47 (1.17 to 5.58) | 0.99 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 15.03 (3.38 to 74.22) | 0.85 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 5.45 (1.58 to 22.65) | 0.98 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 9.88 (1.38 to 51.50) | 0.94 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 5.12 (1.45 to 16.86) | 0.97 |
| Type 2 diabetes (adults) | Weight loss of 10 percent or more | weeks 20 to 40 (target week 26) | Placebo | OR 6.83 (1.78 to 36.90) | 0.97 |
| Type 2 diabetes (adults) | All cause mortality | longest follow-up | Placebo | HR 0.52 (0.28 to 0.97) | 0.95 |
| Type 2 diabetes (adults) | Three point MACE | longest follow-up | Placebo | HR 0.79 (0.43 to 1.46) | 0.61 |
| Type 2 diabetes (adults) | Hospitalization for heart failure | longest follow-up | Placebo | HR 0.87 (0.41 to 1.92) | 0.65 |
| Type 2 diabetes (adults) | SF-36 physical component summary change | weeks 20 to 130 (target week 52) | Placebo | MD -0.28 (-1.08 to 0.50) | 0.22 |
| Type 2 diabetes (adults) | SF-36 physical component summary change | weeks 20 to 130 (target week 52) | Placebo | MD 0.71 (-0.88 to 2.36) | 0.61 |
| Type 2 diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 0.90 (0.75 to 1.10) | 0.58 |
| Type 2 diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 1.78 (1.20 to 2.60) | 0.41 |
| Type 2 diabetes (adults) | Nausea | longest follow-up | Placebo | HR 2.54 (1.86 to 3.48) | 0.41 |
| Type 2 diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 3.44 (2.25 to 5.24) | 0.32 |
| Type 2 diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 1.73 (1.36 to 2.25) | 0.39 |
| Type 2 diabetes (adults) | Constipation | longest follow-up | Placebo | HR 2.29 (1.69 to 3.18) | 0.29 |
| Type 2 diabetes (adults) | Discontinuation due to gastrointestinal adverse events | longest follow-up | Placebo | HR 4.11 (1.31 to 10.82) | 0.25 |
| Type 2 diabetes (adults) | Gallbladder and biliary disease | longest follow-up | Placebo | HR 0.44 (0.01 to 12.04) | 0.64 |
| Type 2 diabetes (adults) | Acute pancreatitis | longest follow-up | Placebo | HR 0.18 (0.02 to 1.45) | 0.75 |
| Type 2 diabetes (adults) | Diabetic retinopathy complications | longest follow-up | Placebo | HR 1.73 (0.57 to 5.37) | 0.32 |
| Type 2 diabetes (adults) | Pancreatic cancer | longest follow-up | Placebo | HR 0.52 (0.04 to 5.96) | 0.61 |
| Type 2 diabetes (adults) | Any cancer | longest follow-up | Placebo | HR 2.77 (0.22 to 47.85) | 0.31 |
| Overweight or obesity without diabetes (adults) | Systolic blood pressure change | weeks 40 to 104 (target week 68) | Placebo | MD -6.00 (-10.41 to -1.63) | 0.79 |
| Overweight or obesity without diabetes (adults) | Percent body weight change | weeks 40 to 104 (target week 68) | Placebo | MD -13.20 (-18.92 to -7.42) | 0.86 |
| Overweight or obesity without diabetes (adults) | Weight loss of 5 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 14.70 (4.59 to 38.73) | 0.51 |
| Overweight or obesity without diabetes (adults) | Weight loss of 10 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 14.39 (3.31 to 47.72) | 0.69 |
| Overweight or obesity without diabetes (adults) | Weight loss of 15 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 17.47 (6.04 to 44.04) | 0.75 |
| Overweight or obesity without diabetes (adults) | Weight loss of 20 percent or more | weeks 40 to 104 (target week 68) | Placebo | OR 17.00 (6.62 to 43.47) | 0.66 |
| Overweight or obesity without diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 1.08 (0.53 to 2.16) | 0.60 |
| Overweight or obesity without diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 1.69 (0.43 to 6.55) | 0.59 |
| Overweight or obesity without diabetes (adults) | Nausea | longest follow-up | Placebo | HR 3.70 (2.45 to 5.34) | 0.47 |
| Overweight or obesity without diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 6.59 (3.07 to 13.62) | 0.38 |
| Overweight or obesity without diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 1.42 (0.78 to 2.45) | 0.65 |
| Overweight or obesity without diabetes (adults) | Constipation | longest follow-up | Placebo | HR 1.81 (0.98 to 3.20) | 0.56 |
| Chronic kidney disease with diabetes | Serious adverse events | longest follow-up | Placebo | HR 0.99 (0.30 to 3.64) | 0.61 |
| Chronic kidney disease with diabetes | Nausea | longest follow-up | Placebo | HR 2.62 (0.71 to 8.60) | 0.44 |
| Chronic kidney disease with diabetes | Vomiting | longest follow-up | Placebo | HR 8.22 (1.53 to 46.13) | 0.23 |
| Chronic kidney disease with diabetes | Diarrhea | longest follow-up | Placebo | HR 2.78 (0.70 to 11.28) | 0.43 |
| Chronic kidney disease with diabetes | Constipation | longest follow-up | Placebo | HR 3.09 (0.70 to 12.66) | 0.32 |
Trials
- ACHIEVE-3A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)2023 · 1,698 randomized · 52 weeks
- NCT05579977A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM2022 · 902 randomized · 32 weeks
- S0030362022 · 58 randomized · 24 weeks
- OASIS 1Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)2021 · 667 randomized · 68 weeks
- PIONEER 12China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin2019 · 1,441 randomized · 26 weeks
- PIONEER 11China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only2019 · 521 randomized · 26 weeks
- PIONEER 6A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes2017 · 3,183 randomized
- PIONEER 10Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes2017 · 458 randomized · 52 weeks
- PIONEER 9Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes2017 · 243 randomized · 52 weeks
- PIONEER 8Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)2017 · 731 randomized · 52 weeks
- PIONEER 7Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus2016 · 504 randomized · 104 weeks
- PIONEER 5Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment2016 · 324 randomized · 26 weeks
- PIONEER 4Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus2016 · 711 randomized · 52 weeks
- PIONEER 1Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only.2016 · 703 randomized · 26 weeks
- PIONEER 3Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes2016 · 1,864 randomized · 78 weeks