parallel randomized trial
OASIS 1
Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 50 mg oral once daily (higher dose oral program) Oral semaglutide 50 mg | lifestyle: not reported | 334 | 317 | |
| A2 | Placebo Placebo | lifestyle: not reported | 333 | 295 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 50 mg oral once daily (higher dose oral program) A1 | Placebo A2 |
|---|---|---|---|
| age | mean (years) | 49 | 50 |
| age | sd (years) | 13 | 12 |
| asian | n | 36 | 36 |
| black | n | 21 | 22 |
| female | n | 247 | 238 |
| hispanic | n | 14 | 13 |
| other race native hawaiian pacific islander | n | 2 | 1 |
| other race other | n | 1 | 3 |
| white | n | 246 | 248 |
Analyses this trial contributes to
- Systolic blood pressure changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Systolic blood pressure changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 15 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 15 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 20 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 20 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- ConstipationOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- ConstipationOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
Results
38 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Systolic blood pressure change (2 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 68 | A1 | change | -7 mmHg | 14 | 317 | not stated; full analysis; registry:outcomes | |
| 68 | A2 | change | -1 mmHg | 14 | 295 | not stated; full analysis; registry:outcomes |
Percent body weight change (4 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 68 | A1 vs A2 | md | -12.74 percent | -14.15 to -11.33 | not stated; full analysis; registry:outcomes | ||
| 68 | A1 vs A2 | md | -15.63 percent | -17.07 to -14.18 | not stated; full analysis; registry:outcomes | ||
| 68 | A1 | percent change | -15.8 percent | 10.3 | 317 | not stated; full analysis; registry:outcomes | |
| 68 | A2 | percent change | -2.2 percent | 7.2 | 295 | not stated; full analysis; registry:outcomes |
Weight loss of 5 percent or more (4 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 68 | A1 | responders | 269 / 317 | not stated; full analysis; registry:outcomes | |||
| 68 | A1 vs A2 | or | 12.62 | 8.50 to 18.74 | not stated; full analysis; registry:outcomes | ||
| 68 | A1 vs A2 | or | 55.21 | 32.98 to 92.41 | not stated; full analysis; registry:outcomes | ||
| 68 | A2 | responders | 76 / 295 | not stated; full analysis; registry:outcomes |
Weight loss of 10 percent or more (2 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 68 | A1 | responders | 220 / 317 | not stated; full analysis; registry:outcomes | |||
| 68 | A2 | responders | 35 / 295 | not stated; full analysis; registry:outcomes |
Weight loss of 15 percent or more (2 lines; O11C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 68 | A1 | responders | 170 / 317 | not stated; full analysis; registry:outcomes | |||
| 68 | A2 | responders | 17 / 295 | not stated; full analysis; registry:outcomes |
Weight loss of 20 percent or more (2 lines; O11D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 68 | A1 | responders | 107 / 317 | not stated; full analysis; registry:outcomes | |||
| 68 | A2 | responders | 8 / 295 | not stated; full analysis; registry:outcomes |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 334 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 333 | not stated; safety; registry:adverse_events |
Physical functioning (any instrument) (4 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 68 | A1 | change | 2.4 points | 5.7 | 303 | not stated; full analysis; registry:outcomes | |
| 68 | A1 | change | 14.5 points | 20.2 | 298 | not stated; full analysis; registry:outcomes | |
| 68 | A2 | change | -0.0 points | 5.4 | 280 | not stated; full analysis; registry:outcomes | |
| 68 | A2 | change | 5.0 points | 19.9 | 278 | not stated; full analysis; registry:outcomes |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 32 / 334 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 29 / 333 | not stated; safety; registry:adverse_events |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 173 / 334 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 51 / 333 | not stated; safety; registry:adverse_events |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 80 / 334 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 334 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 333 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 12 / 333 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 89 / 334 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 56 / 333 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 92 / 334 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 50 / 333 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (4 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 334 | not stated; safety; Cholecystitis; registry:adverse_events | ||||
| A1 | events | 4 / 334 | not stated; safety; Cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 333 | not stated; safety; Cholelithiasis; registry:adverse_events | ||||
| A2 | events | 1 / 333 | not stated; safety; Cholecystitis; registry:adverse_events |