parallel randomized trial
STEP 10
Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg | lifestyle: not reported | 138 | 138 | |
| A2 | Placebo Placebo | lifestyle: not reported | 69 | 69 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 2.4 mg subcutaneous once weekly A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 53 | 53 | 53 |
| age | sd (years) | 11 | 11 | 11 |
| asian | n | 4 | 5 | 9 |
| black | n | 6 | 3 | 9 |
| bmi | mean (kg/m2) | 39.9 | ||
| bmi | sd (kg/m2) | 6.6 | ||
| female | n | 100 | 47 | 147 |
| hispanic | n | 6 | 1 | 7 |
| weight | mean (kg) | 111.9 | ||
| weight | sd (kg) | 21.5 | ||
| white | n | 124 | 59 | 183 |
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
41 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 |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | -9 mmHg | 13 | 129 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -1 mmHg | 13 | 66 | not stated; full analysis; registry:outcomes |
Percent body weight change (3 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | percent change | -14.4 percent | 7.9 | 129 | not stated; full analysis; registry:outcomes | |
| 52 | A1 vs A2 | md | -11.19 percent | -12.97 to -9.42 | not stated; full analysis; registry:outcomes | ||
| 52 | A2 | percent change | -2.7 percent | 4.3 | 66 | not stated; full analysis; registry:outcomes |
Weight loss of 5 percent or more (2 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | responders | 111 / 129 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 17 / 66 | 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 |
|---|---|---|---|---|---|---|---|
| 52 | A1 | responders | 95 / 129 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 5 / 66 | 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 |
|---|---|---|---|---|---|---|---|
| 52 | A1 | responders | 62 / 129 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 1 / 66 | 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 |
|---|---|---|---|---|---|---|---|
| 52 | A1 | responders | 32 / 129 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 0 / 66 | not stated; full analysis; registry:outcomes |
Progression to type 2 diabetes (2 lines; O14)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 127 | not stated; full analysis; registry:outcomes | ||||
| A2 | events | 2 / 64 | 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 | 2 / 138 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 138 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 6 / 69 | not stated; safety; registry:adverse_events |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 40 / 138 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 138 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 69 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 16 / 138 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 138 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 69 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 17 / 138 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 138 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 7 / 69 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 25 / 138 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (2 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 138 | not stated; safety; Cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; Cholelithiasis; registry:adverse_events |
Acute pancreatitis (4 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 138 | not stated; safety; Pancreatitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 138 | not stated; safety; Pancreatitis; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; Pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; Pancreatitis; registry:adverse_events |
Thyroid cancer (any) (2 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 138 | not stated; safety; Anaplastic thyroid cancer; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; Anaplastic thyroid cancer; registry:adverse_events |