parallel randomized trial
SURMOUNT-1
Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | lifestyle: standard | 643 | 635 | |
| A2 | Tirzepatide 5 mg subcutaneous once weekly Tirzepatide 5 mg | lifestyle: standard | 630 | 623 | |
| A3 | Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg | lifestyle: standard | 636 | 629 | |
| A4 | Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg | lifestyle: standard | 630 | 625 | |
| A5 | Pooled Pooled tirzepatide 10 mg and 15 mg | lifestyle: standard | 1,254 | ||
| A6 | Pooled Pooled tirzepatide 5, 10 and 15 mg | lifestyle: standard | 1,896 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Tirzepatide 5 mg subcutaneous once weekly A2 | Tirzepatide 10 mg subcutaneous once weekly A3 | Tirzepatide 15 mg subcutaneous once weekly A4 | Pooled A5 | Pooled A6 | Whole trial ALL |
|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 44.4 | 45.6 | 44.7 | 44.9 | |||
| age | sd (years) | 12.5 | 12.7 | 12.4 | 12.3 | |||
| asian | n | 71 | 68 | 71 | 66 | |||
| black | n | 55 | 48 | 47 | 51 | |||
| bmi | mean (kg/m2) | 38.2 | 37.4 | 38.2 | 38.1 | 37.9 | ||
| bmi | sd (kg/m2) | 6.9 | 6.6 | 7.0 | 6.7 | 6.8 | ||
| established cvd | n | 73 | ||||||
| established cvd | percent | 3 | ||||||
| female | n | 436 | 426 | 427 | 425 | |||
| female | percent | 68 | 68 | 67 | 68 | |||
| hba1c | mean (percent) | 5.6 | 5.6 | 5.6 | 5.6 | |||
| hba1c | sd (percent) | 0.4 | 0.4 | 0.4 | 0.4 | |||
| hispanic | n | 310 | 904 | |||||
| hispanic | percent | 48.2 | 47.7 | |||||
| other race american indian alaska native | n | 58 | 56 | 58 | 59 | |||
| other race multiple | n | 7 | 9 | 6 | 8 | |||
| other race native hawaiian pacific islander | n | 2 | 2 | 2 | 3 | |||
| sbp | mean (mmHg) | 123 | 124 | 124 | 123 | |||
| sbp | sd (mmHg) | 13 | 12 | 13 | 13 | |||
| weight | mean (kg) | 104.9 | 102.88 | 105.84 | 105.59 | |||
| weight | sd (kg) | 21.37 | 20.71 | 23.32 | 22.92 | |||
| white | n | 450 | 447 | 452 | 443 |
Analyses this trial contributes to
- 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); descriptive only
- Weight loss of 5 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Weight loss of 10 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Weight loss of 10 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Weight loss of 15 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Weight loss of 15 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Weight loss of 20 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Weight loss of 20 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- SF-36 physical component summary changeOverweight or obesity without diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- SF-36 physical component summary changeOverweight or obesity without diabetes (adults); weeks 20 to 130 (target week 52); 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
- Discontinuation due to 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
273 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Systolic blood pressure change (11 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -1.6 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 24 | A2 | change | -7.8 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 24 | A3 | change | -8.3 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 24 | A4 | change | -8.5 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 72 | A1 | change | -1.3 mmHg | 0.48 | 634 | hypothetical; modified itt; registry:outcomes | |
| 72 | A1 | change | -1.2 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 72 | A2 | change | -7.0 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 72 | A3 | change | -8.2 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 72 | A4 | change | -7.6 mmHg | hypothetical; modified itt; R0018082:Results | |||
| 72 | A6 | change | -8.1 mmHg | 0.27 | 1878 | hypothetical; modified itt; registry:outcomes | |
| 72 | A6 vs A1 | md | -6.8 mmHg | -7.9 to -5.7 | hypothetical; modified itt; registry:outcomes |
Percent body weight change (49 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | percent change | -2.4 percent | 0.40 | 635 | hypothetical; modified itt; registry:outcomes | |
| 72 | A1 | percent change | -2.3 percent | 602 | hypothetical; modified itt; age:less_than_65; R0013402:Figure 1 | ||
| 72 | A1 | percent change | -0.3 percent | 1.6 | 22 | hypothetical; modified itt; region:japan; R0014369:Table 2 | |
| 72 | A1 | percent change | -4.1 percent | 33 | hypothetical; modified itt; age:65_or_older; R0013402:Figure 1 | ||
| 72 | A2 vs A1 | md | -13.8 percent | -15.2 to -12.5 | hypothetical; modified itt; age:less_than_65; R0013402:Figure 1 | ||
| 72 | A2 | percent change | -16.1 percent | 572 | hypothetical; modified itt; age:less_than_65; R0013402:Figure 1 | ||
| 72 | A2 | percent change | -16.0 percent | 0.39 | 623 | hypothetical; modified itt; registry:outcomes | |
| 72 | A2 vs A1 | md | -13.5 percent | -14.6 to -12.5 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 | percent change | -12.0 percent | 1.7 | 23 | hypothetical; modified itt; region:japan; R0014369:Table 2 | |
| 72 | A2 | percent change | -15.8 percent | 51 | hypothetical; modified itt; age:65_or_older; R0013402:Figure 1 | ||
| 72 | A2 vs A1 | md | -11.6 percent | hypothetical; modified itt; age:65_or_older; R0013402:Figure 1 | |||
| 72 | A2 vs A1 | md | -11.7 percent | -16.4 to -7.1 | hypothetical; modified itt; region:japan; R0014369:Table 2 | ||
| 72 | A3 | percent change | -19.5 percent | 31 | hypothetical; modified itt; age:65_or_older; R0013402:Figure 1 | ||
| 72 | A3 | percent change | -21.4 percent | 0.39 | 629 | hypothetical; modified itt; registry:outcomes | |
| 72 | A3 vs A1 | md | -18.9 percent | -20.0 to -17.8 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 vs A1 | md | -15.4 percent | -19.5 to -11.2 | hypothetical; modified itt; age:65_or_older; R0013402:Figure 1 | ||
| 72 | A3 | percent change | -21.4 percent | 598 | hypothetical; modified itt; age:less_than_65; R0013402:Figure 1 | ||
| 72 | A3 vs A1 | md | -19.2 percent | -20.5 to -17.8 | hypothetical; modified itt; age:less_than_65; R0013402:Figure 1 | ||
| 72 | A3 vs A1 | md | -22.1 percent | -26.8 to -17.4 | hypothetical; modified itt; region:japan; R0014369:Table 2 | ||
| 72 | A3 | percent change | -22.4 percent | 1.7 | 21 | hypothetical; modified itt; region:japan; R0014369:Table 2 | |
| 72 | A4 | percent change | -22.6 percent | 590 | hypothetical; modified itt; age:less_than_65; R0013402:Figure 1 | ||
| 72 | A4 | percent change | -22.5 percent | 0.39 | 625 | hypothetical; modified itt; registry:outcomes | |
| 72 | A4 vs A1 | md | -19.1 percent | -23.2 to -15.1 | hypothetical; modified itt; age:65_or_older; R0013402:Figure 1 | ||
| 72 | A4 vs A1 | md | -20.3 percent | -21.6 to -19.0 | hypothetical; modified itt; age:less_than_65; R0013402:Figure 1 | ||
| 72 | A4 | percent change | -23.3 percent | 35 | hypothetical; modified itt; age:65_or_older; R0013402:Figure 1 | ||
| 72 | A4 vs A1 | md | -20.1 percent | -21.2 to -19.0 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 vs A1 | md | -21.8 percent | -26.2 to -17.3 | hypothetical; modified itt; region:japan; R0014369:Table 2 | ||
| 72 | A4 | percent change | -22.1 percent | 1.6 | 24 | hypothetical; modified itt; region:japan; R0014369:Table 2 | |
| 176 | A1 | percent change | -0.6 percent | 20 | hypothetical; modified itt; glycemic_status:prediabetes_age_65_or_older; R0013402:Figure 1 | ||
| 176 | A1 | percent change | -2.1 percent | 0.78 | 264 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | |
| 176 | A1 | percent change | -2.2 percent | 244 | hypothetical; modified itt; glycemic_status:prediabetes_age_less_than_65; R0013402:Figure 1 | ||
| 176 | A2 vs A1 | md | -13.3 percent | -15.5 to -11.1 | hypothetical; modified itt; glycemic_status:prediabetes_age_less_than_65; R0013402:Figure 1 | ||
| 176 | A2 | percent change | -14.0 percent | 28 | hypothetical; modified itt; glycemic_status:prediabetes_age_65_or_older; R0013402:Figure 1 | ||
| 176 | A2 vs A1 | md | -13.3 percent | -22.1 to -4.6 | hypothetical; modified itt; glycemic_status:prediabetes_age_65_or_older; R0013402:Figure 1 | ||
| 176 | A2 | percent change | -15.5 percent | 217 | hypothetical; modified itt; glycemic_status:prediabetes_age_less_than_65; R0013402:Figure 1 | ||
| 176 | A2 | percent change | -15.4 percent | 0.74 | 245 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | |
| 176 | A2 vs A1 | md | -13.2 percent | -15.3 to -11.1 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A3 vs A1 | md | -17.8 percent | -19.9 to -15.6 | hypothetical; modified itt; glycemic_status:prediabetes_age_less_than_65; R0013402:Figure 1 | ||
| 176 | A3 | percent change | -19.9 percent | 243 | hypothetical; modified itt; glycemic_status:prediabetes_age_less_than_65; R0013402:Figure 1 | ||
| 176 | A3 vs A1 | md | -17.7 percent | -19.8 to -15.7 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A3 | percent change | -19.9 percent | 0.72 | 260 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | |
| 176 | A3 vs A1 | md | -18.4 percent | -28.2 to -8.6 | hypothetical; modified itt; glycemic_status:prediabetes_age_65_or_older; R0013402:Figure 1 | ||
| 176 | A3 | percent change | -19.1 percent | 17 | hypothetical; modified itt; glycemic_status:prediabetes_age_65_or_older; R0013402:Figure 1 | ||
| 176 | A4 vs A1 | md | -20.5 percent | -22.7 to -18.3 | hypothetical; modified itt; glycemic_status:prediabetes_age_less_than_65; R0013402:Figure 1 | ||
| 176 | A4 | percent change | -22.9 percent | 0.73 | 249 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | |
| 176 | A4 vs A1 | md | -20.7 percent | -22.8 to -18.6 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A4 | percent change | -22.7 percent | 229 | hypothetical; modified itt; glycemic_status:prediabetes_age_less_than_65; R0013402:Figure 1 | ||
| 176 | A4 vs A1 | md | -25.2 percent | -34.4 to -16.0 | hypothetical; modified itt; glycemic_status:prediabetes_age_65_or_older; R0013402:Figure 1 | ||
| 176 | A4 | percent change | -25.9 percent | 20 | hypothetical; modified itt; glycemic_status:prediabetes_age_65_or_older; R0013402:Figure 1 |
Weight loss of 5 percent or more (14 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | responders | 27.87 | 635 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 | responders | 89.41 | 623 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 vs A1 | or | 23.99 | 17.43 to 33.02 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 | responders | 96.18 | 629 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 vs A1 | or | 73.63 | 46.98 to 115.39 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 | responders | 96.32 | 625 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 vs A1 | or | 75.48 | 47.86 to 119.03 | hypothetical; modified itt; registry:outcomes | ||
| 176 | A1 | responders | 24.62 | 264 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A2 | responders | 90.61 | 245 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A2 vs A1 | or | 29.79 | 17.73 to 50.05 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A3 | responders | 91.92 | 260 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A3 vs A1 | or | 35.05 | 20.63 to 59.53 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A4 | responders | 94.78 | 249 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes | ||
| 176 | A4 vs A1 | or | 55.05 | 29.61 to 102.34 | hypothetical; modified itt; glycemic_status:prediabetes; registry:outcomes |
Weight loss of 10 percent or more (7 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | responders | 13.54 | 635 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 | responders | 73.35 | 623 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 vs A1 | or | 19.03 | 14.15 to 25.60 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 | responders | 85.85 | 629 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 vs A1 | or | 44.17 | 31.75 to 61.45 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 | responders | 90.08 | 625 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 vs A1 | or | 65.64 | 45.94 to 93.77 | hypothetical; modified itt; registry:outcomes |
Weight loss of 15 percent or more (7 lines; O11C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | responders | 5.98 | 635 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 | responders | 50.24 | 623 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 vs A1 | or | 17.08 | 11.83 to 24.66 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 | responders | 73.61 | 629 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 vs A1 | or | 51.84 | 35.42 to 75.88 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 | responders | 78.24 | 625 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 vs A1 | or | 66.63 | 45.23 to 98.16 | hypothetical; modified itt; registry:outcomes |
Weight loss of 20 percent or more (7 lines; O11D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | responders | 1.26 | 635 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 | responders | 31.62 | 623 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A2 vs A1 | or | 36.93 | 18.37 to 74.22 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 | responders | 55.48 | 629 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A3 vs A1 | or | 109.45 | 54.50 to 219.81 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 | responders | 62.88 | 625 | hypothetical; modified itt; registry:outcomes | ||
| 72 | A4 vs A1 | or | 150.59 | 74.85 to 302.97 | hypothetical; modified itt; registry:outcomes |
Acute kidney injury (4 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 643 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 630 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; registry:adverse_events |
Progression to type 2 diabetes (6 lines; O14)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12.6 | 270 | not stated; modified itt; glycemic_status:prediabetes; registry:outcomes | |||
| A1 | events | 13.7 | 270 | not stated; modified itt; glycemic_status:prediabetes; registry:outcomes | |||
| A6 vs A1 | hr | 0.06 | 0.03 to 0.13 | not stated; modified itt; glycemic_status:prediabetes; registry:outcomes | |||
| A6 | events | 1.2 | 762 | not stated; modified itt; glycemic_status:prediabetes; registry:outcomes | |||
| A6 | events | 2.4 | 762 | not stated; modified itt; glycemic_status:prediabetes; registry:outcomes | |||
| A6 vs A1 | hr | 0.12 | 0.07 to 0.21 | not stated; modified itt; glycemic_status:prediabetes; registry:outcomes |
All cause mortality (12 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 27 | not stated; modified itt; region:japan; R0014369:Table 4 | ||||
| A1 | events | 4 / 643 | not stated; randomized; registry:flow | ||||
| A1 | events | 4 / 643 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 630 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 24 | not stated; modified itt; region:japan; R0014369:Table 4 | ||||
| A2 | events | 4 / 630 | not stated; randomized; registry:flow | ||||
| A3 | events | 2 / 636 | not stated; randomized; registry:flow | ||||
| A3 | events | 0 / 22 | not stated; modified itt; region:japan; R0014369:Table 4 | ||||
| A3 | events | 3 / 636 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; randomized; registry:flow | ||||
| A4 | events | 2 / 630 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 29 | not stated; modified itt; region:japan; R0014369:Table 4 |
Hospitalization for heart failure (4 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 643 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; cardiac failure acute; registry:adverse_events |
SF-36 physical component summary change (7 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | change | 1.62 points | 0.25 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A2 | change | 3.47 points | 0.23 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A2 vs A1 | md | 1.84 points | 1.18 to 2.51 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A3 | change | 3.63 points | 0.23 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A3 vs A1 | md | 2.00 points | 1.33 to 2.67 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A4 | change | 4.18 points | 0.23 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A4 vs A1 | md | 2.56 points | 1.89 to 3.23 | hypothetical; modified itt; R0006704:Table 2 |
Physical functioning (any instrument) (17 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | change | 10.1 points | 0.8 | 477 | hypothetical; modified itt; R0006704:Table 3 | |
| 72 | A1 | change | 1.76 points | 0.26 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A1 | change | 1.7 points | 0.27 | 482 | hypothetical; modified itt; registry:outcomes | |
| 72 | A2 | change | 17.8 points | 0.7 | 545 | hypothetical; modified itt; R0006704:Table 3 | |
| 72 | A2 | change | 3.87 points | 0.25 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A2 vs A1 | md | 7.7 points | 5.6 to 9.8 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A2 vs A1 | md | 2.11 points | 1.39 to 2.82 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A3 | change | 3.89 points | 0.25 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A3 | change | 20.7 points | 0.7 | 539 | hypothetical; modified itt; R0006704:Table 3 | |
| 72 | A3 vs A1 | md | 10.7 points | 8.6 to 12.8 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A3 vs A1 | md | 2.13 points | 1.42 to 2.84 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A4 | change | 4.14 points | 0.25 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A4 vs A1 | md | 11.7 points | 9.6 to 13.8 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A4 vs A1 | md | 2.38 points | 1.67 to 3.09 | hypothetical; modified itt; R0006704:Table 2 | ||
| 72 | A4 | change | 21.8 points | 0.7 | 535 | hypothetical; modified itt; R0006704:Table 3 | |
| 72 | A5 | change | 4.0 points | 0.18 | 1080 | hypothetical; modified itt; registry:outcomes | |
| 72 | A5 vs A1 | md | 2.3 points | 1.6 to 2.9 | hypothetical; modified itt; registry:outcomes |
Health related quality of life total score (any instrument) (14 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | change | 0.02 points | 0.01 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A1 | change | 10.5 points | 0.7 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A2 | change | 0.04 points | 0.01 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A2 | change | 18.6 points | 0.6 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A2 vs A1 | md | 0.03 points | 0.01 to 0.04 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A2 vs A1 | md | 8.1 points | 6.3 to 9.9 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A3 | change | 0.05 points | 0.01 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A3 | change | 21.2 points | 0.6 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A3 vs A1 | md | 0.03 points | 0.01 to 0.05 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A3 vs A1 | md | 10.7 points | 8.9 to 12.5 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A4 | change | 0.06 points | 0.01 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A4 | change | 22.6 points | 0.6 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A4 vs A1 | md | 0.05 points | 0.03 to 0.06 | hypothetical; modified itt; R0006704:Table 3 | ||
| 72 | A4 vs A1 | md | 12.1 points | 10.3 to 13.9 | hypothetical; modified itt; R0006704:Table 3 |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 53 / 643 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 57 / 630 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 60 / 636 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 50 / 630 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (16 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 213 | not stated; other; glycemic_status:prediabetes; registry:flow | ||||
| A1 | events | 6 / 478 | not stated; other; registry:flow | ||||
| A1 | events | 17 / 643 | not stated; randomized; R0018082:Figure 1 | ||||
| A1 | events | 7 / 643 | not stated; randomized; R0018082:Figure 1 | ||||
| A1 | events | 6 / 643 | not stated; randomized; registry:flow | ||||
| A2 | events | 8 / 543 | not stated; other; registry:flow | ||||
| A2 | events | 2 / 227 | not stated; other; glycemic_status:prediabetes; registry:flow | ||||
| A2 | events | 4 / 630 | not stated; randomized; registry:flow | ||||
| A3 | events | 8 / 636 | not stated; randomized; registry:flow | ||||
| A3 | events | 9 / 548 | not stated; other; registry:flow | ||||
| A3 | events | 1 / 229 | not stated; other; glycemic_status:prediabetes; registry:flow | ||||
| A4 | events | 0 / 232 | not stated; other; glycemic_status:prediabetes; registry:flow | ||||
| A4 | events | 6 / 630 | not stated; randomized; registry:flow | ||||
| A4 | events | 16 / 560 | not stated; other; registry:flow | ||||
| A6 | events | 26 / 1896 | not stated; randomized; R0018082:Figure 1 | ||||
| A6 | events | 111 / 1896 | not stated; randomized; R0018082:Figure 1 |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 63 / 643 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 160 / 630 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 217 / 636 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 201 / 630 | not stated; safety; registry:adverse_events |
Vomiting (8 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 643 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 58 / 630 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 74 / 636 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 81 / 630 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; registry:adverse_events |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 51 / 643 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 128 / 630 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 143 / 636 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 149 / 630 | not stated; safety; registry:adverse_events |
Constipation (8 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 38 / 643 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 113 / 630 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 117 / 636 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 80 / 630 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (32 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 643 | not stated; safety; cholangitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; biliary obstruction; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; biloma; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 3 / 643 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A1 | events | 3 / 643 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; cholangitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; biloma; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; biliary obstruction; registry:adverse_events | ||||
| A2 | events | 2 / 630 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 3 / 630 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A2 | events | 1 / 630 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; biliary obstruction; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; biloma; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; cholangitis acute; registry:adverse_events | ||||
| A3 | events | 3 / 636 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 2 / 636 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 6 / 636 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; cholangitis acute; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 7 / 630 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; biloma; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; biliary obstruction; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; bile duct stone; registry:adverse_events |
Acute pancreatitis (12 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 643 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 2 / 643 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A2 | events | 3 / 630 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; pancreatitis; registry:adverse_events |
Thyroid cancer (any) (4 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 643 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; papillary thyroid cancer; registry:adverse_events |
Suicidal ideation or behavior (6 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 643 | not stated; safety; suicide attempt; registry:adverse_events | ||||
| A1 | events | 3 / 268 | not stated; safety; glycemic_status:prediabetes; R0007749:Supplement Table S4 | ||||
| A2 | events | 0 / 630 | not stated; safety; suicide attempt; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; suicide attempt; registry:adverse_events | ||||
| A4 | events | 1 / 630 | not stated; safety; suicide attempt; registry:adverse_events | ||||
| A6 | events | 6 / 758 | not stated; safety; glycemic_status:prediabetes; R0007749:Supplement Table S4 |
Intestinal obstruction or ileus (12 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 643 | not stated; safety; ileus; registry:adverse_events | ||||
| A1 | events | 0 / 643 | not stated; safety; ileus paralytic; registry:adverse_events | ||||
| A1 | events | 1 / 643 | not stated; safety; intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 1 / 630 | not stated; safety; ileus paralytic; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; ileus; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; intestinal obstruction; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; ileus paralytic; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; ileus; registry:adverse_events | ||||
| A3 | events | 0 / 636 | not stated; safety; intestinal obstruction; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; ileus paralytic; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; ileus; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; intestinal obstruction; registry:adverse_events |
Pancreatic cancer (4 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 643 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A2 | events | 0 / 630 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A3 | events | 1 / 636 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A4 | events | 0 / 630 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events |