parallel randomized trial
NCT04881760
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | lifestyle: standard | 70 | 68 | |
| A2 | Retatrutide 1 mg subcutaneous once weekly 1 mg LY3437943 | lifestyle: standard | 69 | 69 | |
| A3 | Retatrutide 4 mg subcutaneous once weekly 4 mg LY3437943 (2 mg start) | lifestyle: standard | 33 | 33 | |
| A4 | Retatrutide 4 mg subcutaneous once weekly 4 mg LY3437943 (4 mg start) | lifestyle: standard | 34 | 33 | |
| A5 | Retatrutide 8 mg subcutaneous once weekly 8 mg LY3437943 (2 mg start) | lifestyle: standard | 35 | 35 | |
| A6 | Retatrutide 8 mg subcutaneous once weekly 8 mg LY3437943 (4 mg start) | lifestyle: standard | 35 | 35 | |
| A7 | Retatrutide 12 mg subcutaneous once weekly 12 mg LY3437943 (2 mg start) | lifestyle: standard | 62 | 62 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Retatrutide 1 mg subcutaneous once weekly A2 | Retatrutide 4 mg subcutaneous once weekly A3 | Retatrutide 4 mg subcutaneous once weekly A4 | Retatrutide 8 mg subcutaneous once weekly A5 | Retatrutide 8 mg subcutaneous once weekly A6 | Retatrutide 12 mg subcutaneous once weekly A7 |
|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 48.00 | 50.60 | 50.80 | 46.80 | 46.10 | 48.70 | 45.80 |
| age | sd (years) | 12.54 | 13.30 | 11.88 | 14.10 | 13.52 | 11.14 | 12.18 |
| asian | n | 2 | 0 | 0 | 0 | 1 | 0 | 1 |
| black | n | 8 | 6 | 4 | 2 | 4 | 1 | 2 |
| bmi | mean (kg/m2) | 37.31 | 37.49 | 37.27 | 37.39 | 37.37 | 36.96 | 37.42 |
| bmi | sd (kg/m2) | 5.90 | 5.85 | 5.87 | 4.66 | 6.04 | 5.49 | 5.98 |
| female | n | 34 | 33 | 16 | 16 | 17 | 17 | 30 |
| hispanic | n | 22 | 23 | 9 | 14 | 15 | 12 | 22 |
| other race american indian alaska native | n | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| other race multiple | n | 1 | 0 | 0 | 1 | 0 | 1 | 2 |
| other race native hawaiian pacific islander | n | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| weight | mean (kg) | 109.21 | 106.36 | 108.04 | 107.01 | 106.50 | 108.63 | 107.97 |
| weight | sd (kg) | 20.88 | 19.84 | 26.31 | 21.29 | 21.55 | 20.88 | 21.69 |
| white | n | 59 | 61 | 29 | 30 | 30 | 33 | 56 |
Analyses this trial contributes to
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 20 to 40 (target week 26); 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
- 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
- Death by suicideOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- Death by suicideOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
Results
204 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (26 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | percent change | -1.55 percent | 0.54 | 68 | hypothetical; modified itt; registry:outcomes | |
| 24 | A2 | percent change | -7.18 percent | 0.67 | 69 | hypothetical; modified itt; registry:outcomes | |
| 24 | A2 vs A1 | md | -5.64 percent | -7.34 to -3.94 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 | percent change | -12.00 percent | 0.71 | 33 | hypothetical; modified itt; registry:outcomes | |
| 24 | A3 vs A1 | md | -10.45 percent | -12.21 to -8.70 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 | percent change | -13.80 percent | 0.97 | 33 | hypothetical; modified itt; registry:outcomes | |
| 24 | A4 vs A1 | md | -12.25 percent | -14.42 to -10.08 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 | percent change | -16.64 percent | 0.74 | 35 | hypothetical; modified itt; registry:outcomes | |
| 24 | A5 vs A1 | md | -15.10 percent | -16.90 to -13.30 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 | percent change | -18.26 percent | 0.95 | 35 | hypothetical; modified itt; registry:outcomes | |
| 24 | A6 vs A1 | md | -16.72 percent | -18.86 to -14.58 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 | percent change | -17.39 percent | 0.69 | 62 | hypothetical; modified itt; registry:outcomes | |
| 24 | A7 vs A1 | md | -15.85 percent | -17.57 to -14.13 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A1 | percent change | -2.11 percent | 0.73 | 68 | hypothetical; modified itt; registry:outcomes | |
| 48 | A2 | percent change | -8.67 percent | 0.95 | 69 | hypothetical; modified itt; registry:outcomes | |
| 48 | A2 vs A1 | md | -6.57 percent | -8.94 to -4.20 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A3 | percent change | -16.32 percent | 1.58 | 33 | hypothetical; modified itt; registry:outcomes | |
| 48 | A3 vs A1 | md | -14.21 percent | -17.64 to -10.78 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A4 | percent change | -17.83 percent | 1.53 | 33 | hypothetical; modified itt; registry:outcomes | |
| 48 | A4 vs A1 | md | -15.72 percent | -19.05 to -12.40 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A5 | percent change | -21.72 percent | 1.41 | 35 | hypothetical; modified itt; registry:outcomes | |
| 48 | A5 vs A1 | md | -19.62 percent | -22.73 to -16.51 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A6 | percent change | -23.88 percent | 1.51 | 35 | hypothetical; modified itt; registry:outcomes | |
| 48 | A6 vs A1 | md | -21.78 percent | -25.05 to -18.51 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A7 | percent change | -24.22 percent | 1.24 | 62 | hypothetical; modified itt; registry:outcomes | |
| 48 | A7 vs A1 | md | -22.11 percent | -24.92 to -19.31 | hypothetical; modified itt; registry:outcomes |
Weight loss of 5 percent or more (26 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 26 | 68 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A2 | responders | 59 | 69 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A2 vs A1 | rd | 33 | 17 to 49 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 | responders | 87 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 vs A1 | rd | 61 | 45 to 77 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 | responders | 94 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 vs A1 | rd | 68 | 54 to 81 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 | responders | 100 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 vs A1 | rd | 74 | 63 to 85 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 | responders | 100 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 vs A1 | rd | 74 | 63 to 85 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 | responders | 97 | 62 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 vs A1 | rd | 71 | 59 to 82 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A1 | responders | 27 | 68 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A2 | responders | 64 | 69 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A2 vs A1 | rd | 37 | 20 to 54 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A3 | responders | 87 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A3 vs A1 | rd | 60 | 44 to 76 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A4 | responders | 97 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A4 vs A1 | rd | 70 | 57 to 83 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A5 | responders | 100 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A5 vs A1 | rd | 73 | 62 to 84 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A6 | responders | 100 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A6 vs A1 | rd | 73 | 62 to 84 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A7 | responders | 100 | 62 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A7 vs A1 | rd | 73 | 67 to 84 | hypothetical; modified itt; registry:outcomes |
Weight loss of 10 percent or more (26 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 3 | 68 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A2 | responders | 25 | 69 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A2 vs A1 | rd | 22 | 11 to 33 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 | responders | 59 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 vs A1 | rd | 56 | 38 to 73 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 | responders | 72 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 vs A1 | rd | 69 | 53 to 85 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 | responders | 83 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 vs A1 | rd | 80 | 66 to 93 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 | responders | 94 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 vs A1 | rd | 91 | 83 to 100 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 | responders | 90 | 62 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 vs A1 | rd | 87 | 78 to 96 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A1 | responders | 9 | 68 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A2 | responders | 27 | 69 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A2 vs A1 | rd | 18 | 5 to 31 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A3 | responders | 73 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A3 vs A1 | rd | 64 | 48 to 81 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A4 | responders | 76 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A4 vs A1 | rd | 67 | 51 to 84 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A5 | responders | 90 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A5 vs A1 | rd | 81 | 69 to 94 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A6 | responders | 91 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A6 vs A1 | rd | 82 | 71 to 94 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A7 | responders | 93 | 62 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A7 vs A1 | rd | 84 | 74 to 94 | hypothetical; modified itt; registry:outcomes |
Weight loss of 15 percent or more (26 lines; O11C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 1 | 68 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A2 | responders | 10 | 69 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A2 vs A1 | rd | 9 | 1 to 17 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 | responders | 29 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 vs A1 | rd | 27 | 11 to 43 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 | responders | 44 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 vs A1 | rd | 43 | 26 to 60 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 | responders | 51 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 vs A1 | rd | 49 | 33 to 66 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 | responders | 68 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 vs A1 | rd | 67 | 51 to 83 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 | responders | 70 | 62 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 vs A1 | rd | 68 | 56 to 80 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A1 | responders | 2 | 68 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A2 | responders | 16 | 69 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A2 vs A1 | rd | 15 | 6 to 24 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A3 | responders | 55 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A3 vs A1 | rd | 53 | 36 to 70 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A4 | responders | 64 | 33 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A4 vs A1 | rd | 63 | 47 to 79 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A5 | responders | 73 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A5 vs A1 | rd | 71 | 55 to 87 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A6 | responders | 77 | 35 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A6 vs A1 | rd | 75 | 62 to 89 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A7 | responders | 83 | 62 | hypothetical; modified itt; registry:outcomes | ||
| 48 | A7 vs A1 | rd | 82 | 71 to 92 | hypothetical; modified itt; registry:outcomes |
Acute kidney injury (7 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 1 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 62 | not stated; safety; registry:adverse_events |
All cause mortality (7 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 62 | not stated; safety; registry:adverse_events |
Hospitalization for heart failure (8 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A4 | events | 0 / 33 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A5 | events | 1 / 35 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A6 | events | 0 / 35 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A7 | events | 0 / 62 | not stated; safety; cardiac failure; registry:adverse_events |
Serious adverse events (7 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 2 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 2 / 62 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (7 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; randomized; registry:flow | ||||
| A2 | events | 1 / 69 | not stated; randomized; registry:flow | ||||
| A3 | events | 1 / 33 | not stated; randomized; registry:flow | ||||
| A4 | events | 0 / 34 | not stated; randomized; registry:flow | ||||
| A5 | events | 1 / 35 | not stated; randomized; registry:flow | ||||
| A6 | events | 1 / 35 | not stated; randomized; registry:flow | ||||
| A7 | events | 2 / 62 | not stated; randomized; registry:flow |
Nausea (7 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 10 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 6 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 12 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 6 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 21 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 28 / 62 | not stated; safety; registry:adverse_events |
Vomiting (14 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 70 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 69 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 4 / 33 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 4 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 2 / 35 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 9 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 1 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 12 / 62 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 62 | not stated; safety; registry:adverse_events |
Diarrhea (7 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 6 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 4 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 4 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 7 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 7 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 9 / 62 | not stated; safety; registry:adverse_events |
Constipation (14 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 70 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 70 | not stated; safety; faeces hard; registry:adverse_events | ||||
| A2 | events | 5 / 69 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; faeces hard; registry:adverse_events | ||||
| A3 | events | 5 / 33 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; faeces hard; registry:adverse_events | ||||
| A4 | events | 2 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 33 | not stated; safety; faeces hard; registry:adverse_events | ||||
| A5 | events | 4 / 35 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 35 | not stated; safety; faeces hard; registry:adverse_events | ||||
| A6 | events | 4 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 2 / 35 | not stated; safety; faeces hard; registry:adverse_events | ||||
| A7 | events | 10 / 62 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 62 | not stated; safety; faeces hard; registry:adverse_events |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; randomized; registry:flow | ||||
| A4 | events | 0 / 34 | not stated; randomized; registry:flow |
Gallbladder and biliary disease (7 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 33 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 35 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A6 | events | 1 / 35 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 62 | not stated; safety; cholecystitis acute; registry:adverse_events |
Acute pancreatitis (7 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 1 / 62 | not stated; safety; registry:adverse_events |
Death by suicide (6 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 70 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 69 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 33 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 35 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 62 | not stated; safety; registry:adverse_events |