parallel randomized trial
NCT04867785
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | diet and exercise alone or stable metformin; lifestyle: not reported | 45 | 45 | |
| A2 | Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg | diet and exercise alone or stable metformin; lifestyle: not reported | 46 | 46 | |
| A3 | Retatrutide 0.5 mg subcutaneous once weekly Retatrutide 0.5 mg | diet and exercise alone or stable metformin; lifestyle: not reported | 47 | 46 | |
| A4 | Retatrutide 4 mg subcutaneous once weekly Retatrutide 4 mg (2 mg start) | diet and exercise alone or stable metformin; lifestyle: not reported | 23 | 22 | |
| A5 | Retatrutide 4 mg subcutaneous once weekly Retatrutide 4 mg (4 mg start) | diet and exercise alone or stable metformin; lifestyle: not reported | 24 | 24 | |
| A6 | Retatrutide 8 mg subcutaneous once weekly Retatrutide 8 mg (2 mg start) | diet and exercise alone or stable metformin; lifestyle: not reported | 26 | 25 | |
| A7 | Retatrutide 8 mg subcutaneous once weekly Retatrutide 8 mg (4 mg start) | diet and exercise alone or stable metformin; lifestyle: not reported | 24 | 24 | |
| A8 | Retatrutide 12 mg subcutaneous once weekly Retatrutide 12 mg (2 mg start) | diet and exercise alone or stable metformin; lifestyle: not reported | 46 | 43 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Dulaglutide 1.5 mg subcutaneous once weekly A2 | Retatrutide 0.5 mg subcutaneous once weekly A3 | Retatrutide 4 mg subcutaneous once weekly A4 | Retatrutide 4 mg subcutaneous once weekly A5 | Retatrutide 8 mg subcutaneous once weekly A6 | Retatrutide 8 mg subcutaneous once weekly A7 | Retatrutide 12 mg subcutaneous once weekly A8 | Whole trial ALL |
|---|---|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 57.56 | 54.94 | 57.21 | 57.70 | 57.58 | 57.00 | 53.83 | 54.37 | |
| age | sd (years) | 10.83 | 10.45 | 9.69 | 8.14 | 10.00 | 7.37 | 9.03 | 9.72 | |
| asian | n | 3 | 1 | 0 | 2 | 0 | 0 | 0 | 2 | |
| black | n | 5 | 9 | 6 | 1 | 2 | 3 | 4 | 3 | |
| bmi | mean (kg/m2) | 33.8 | 36.3 | 34.7 | 35.5 | 35.0 | ||||
| bmi | sd (kg/m2) | 4.9 | 6.8 | 5.6 | 6.9 | 6.3 | ||||
| diabetes duration | mean (years) | 8.7 | 7.2 | 8.8 | 7.9 | 8.1 | ||||
| diabetes duration | sd (years) | 8.3 | 6.5 | 6.7 | 6.9 | 7.0 | ||||
| egfr | mean (mL/min/1.73 m2) | 90.7 | 91.1 | 95.1 | 91.1 | |||||
| egfr | sd (mL/min/1.73 m2) | 21.1 | 21.7 | 14.5 | 19.2 | |||||
| female | n | 23 | 33 | 23 | 8 | 12 | 16 | 15 | 26 | |
| hba1c | mean (percent) | 8.39 | 8.22 | 8.35 | 8.07 | 8.20 | 8.34 | 8.20 | 8.28 | |
| hba1c | sd (percent) | 1.139 | 0.919 | 1.172 | 0.870 | 1.207 | 1.120 | 1.261 | 1.066 | |
| hispanic | n | 21 | 20 | 27 | 9 | 13 | 12 | 9 | 20 | |
| other american indian alaska native | n | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | |
| other multiple race | n | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | |
| sbp | mean (mmHg) | 131.9 | 127.6 | 132.0 | 124.7 | |||||
| sbp | sd (mmHg) | 15.0 | 12.1 | 11.6 | 13.7 | |||||
| sglt2i use | n | 0 | 0 | 0 | 1 | |||||
| uacr: ge30 | n | 10 | 5 | 11 | 15 | |||||
| weight | mean (kg) | 94.6 | 100.3 | 96.7 | 99.9 | |||||
| weight | sd (kg) | 16.6 | 23.4 | 18.1 | 22.7 | |||||
| white | n | 36 | 36 | 40 | 20 | 22 | 23 | 20 | 38 |
Analyses this trial contributes to
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
198 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (40 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -0.05 percent | 0.21 | 45 | hypothetical; modified itt; registry:outcomes | |
| 24 | A2 | change | -1.41 percent | 0.12 | 46 | hypothetical; modified itt; registry:outcomes | |
| 24 | A3 | change | -0.43 percent | 0.20 | 46 | hypothetical; modified itt; registry:outcomes | |
| 24 | A3 vs A1 | md | -0.38 percent | -0.94 to 0.18 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 vs A2 | md | 0.98 percent | 0.52 to 1.43 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 | change | -1.39 percent | 0.14 | 22 | hypothetical; modified itt; registry:outcomes | |
| 24 | A4 vs A1 | md | -1.34 percent | -1.84 to -0.85 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 vs A2 | md | 0.01 percent | -0.34 to 0.37 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 | change | -1.30 percent | 0.22 | 24 | hypothetical; modified itt; registry:outcomes | |
| 24 | A5 vs A1 | md | -1.25 percent | -1.85 to -0.65 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 vs A2 | md | 0.11 percent | -0.39 to 0.60 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 | change | -1.99 percent | 0.15 | 25 | hypothetical; modified itt; registry:outcomes | |
| 24 | A6 vs A1 | md | -1.94 percent | -2.44 to -1.43 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 vs A2 | md | -0.58 percent | -0.95 to -0.21 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 | change | -1.88 percent | 0.21 | 24 | hypothetical; modified itt; registry:outcomes | |
| 24 | A7 vs A1 | md | -1.83 percent | -2.42 to -1.24 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 vs A2 | md | -0.47 percent | -0.95 to 0.01 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A8 | change | -2.01 percent | 0.11 | 43 | hypothetical; modified itt; registry:outcomes | |
| 24 | A8 vs A1 | md | -1.96 percent | -2.43 to -1.50 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A8 vs A2 | md | -0.61 percent | -0.93 to -0.29 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A1 | change | -0.30 percent | 0.24 | 45 | hypothetical; modified itt; registry:outcomes | |
| 36 | A2 | change | -1.36 percent | 0.13 | 46 | hypothetical; modified itt; registry:outcomes | |
| 36 | A3 | change | -0.54 percent | 0.20 | 46 | hypothetical; modified itt; registry:outcomes | |
| 36 | A3 vs A1 | md | -0.24 percent | -0.85 to 0.38 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A3 vs A2 | md | 0.82 percent | 0.35 to 1.29 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A4 | change | -1.30 percent | 0.20 | 22 | hypothetical; modified itt; registry:outcomes | |
| 36 | A4 vs A1 | md | -0.99 percent | -1.60 to -0.38 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A4 vs A2 | md | 0.06 percent | -0.41 to 0.53 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A5 | change | -1.50 percent | 0.19 | 24 | hypothetical; modified itt; registry:outcomes | |
| 36 | A5 vs A1 | md | -1.20 percent | -1.80 to -0.59 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A5 vs A2 | md | -0.14 percent | -0.61 to 0.32 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A6 | change | -2.13 percent | 0.17 | 25 | hypothetical; modified itt; registry:outcomes | |
| 36 | A6 vs A1 | md | -1.83 percent | -2.41 to -1.24 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A6 vs A2 | md | -0.77 percent | -1.19 to -0.36 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A7 | change | -1.93 percent | 0.22 | 24 | hypothetical; modified itt; registry:outcomes | |
| 36 | A7 vs A1 | md | -1.63 percent | -2.27 to -0.99 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A7 vs A2 | md | -0.57 percent | -1.08 to -0.07 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A8 | change | -2.16 percent | 0.13 | 43 | hypothetical; modified itt; registry:outcomes | |
| 36 | A8 vs A1 | md | -1.85 percent | -2.39 to -1.31 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A8 vs A2 | md | -0.80 percent | -1.16 to -0.44 | hypothetical; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (40 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -1.86 kg | 0.66 | 45 | hypothetical; modified itt; registry:outcomes | |
| 24 | A2 | change | -1.16 kg | 0.63 | 46 | hypothetical; modified itt; registry:outcomes | |
| 24 | A3 | change | -2.35 kg | 0.48 | 46 | hypothetical; modified itt; registry:outcomes | |
| 24 | A3 vs A1 | md | -0.49 kg | -2.07 to 1.08 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 vs A2 | md | -1.19 kg | -2.75 to 0.37 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 | change | -6.27 kg | 0.94 | 22 | hypothetical; modified itt; registry:outcomes | |
| 24 | A4 vs A1 | md | -4.41 kg | -6.69 to -2.13 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 vs A2 | md | -5.11 kg | -7.36 to -2.86 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 | change | -8.64 kg | 1.23 | 24 | hypothetical; modified itt; registry:outcomes | |
| 24 | A5 vs A1 | md | -6.78 kg | -9.47 to -4.09 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 vs A2 | md | -7.48 kg | -10.19 to -4.77 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 | change | -11.99 kg | 0.84 | 25 | hypothetical; modified itt; registry:outcomes | |
| 24 | A6 vs A1 | md | -10.13 kg | -12.24 to -8.03 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 vs A2 | md | -10.83 kg | -12.89 to -8.77 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 | change | -13.91 kg | 1.38 | 24 | hypothetical; modified itt; registry:outcomes | |
| 24 | A7 vs A1 | md | -12.06 kg | -15.06 to -9.06 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 vs A2 | md | -12.76 kg | -15.74 to -9.77 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A8 | change | -12.84 kg | 0.93 | 43 | hypothetical; modified itt; registry:outcomes | |
| 24 | A8 vs A1 | md | -10.99 kg | -13.24 to -8.73 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A8 vs A2 | md | -11.69 kg | -13.90 to -9.47 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A1 | change | -3.28 kg | 0.92 | 45 | hypothetical; modified itt; registry:outcomes | |
| 36 | A2 | change | -1.97 kg | 0.87 | 46 | hypothetical; modified itt; registry:outcomes | |
| 36 | A3 | change | -3.31 kg | 0.62 | 46 | hypothetical; modified itt; registry:outcomes | |
| 36 | A3 vs A1 | md | -0.03 kg | -2.18 to 2.12 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A3 vs A2 | md | -1.34 kg | -3.45 to 0.77 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A4 | change | -7.28 kg | 1.39 | 22 | hypothetical; modified itt; registry:outcomes | |
| 36 | A4 vs A1 | md | -4.00 kg | -7.32 to -0.68 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A4 vs A2 | md | -5.31 kg | -8.66 to -1.97 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A5 | change | -10.37 kg | 1.49 | 24 | hypothetical; modified itt; registry:outcomes | |
| 36 | A5 vs A1 | md | -7.09 kg | -10.46 to -3.71 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A5 vs A2 | md | -8.40 kg | -11.76 to -5.04 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A6 | change | -16.48 kg | 1.55 | 25 | hypothetical; modified itt; registry:outcomes | |
| 36 | A6 vs A1 | md | -13.20 kg | -16.74 to -9.66 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A6 vs A2 | md | -14.51 kg | -18.00 to -11.01 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A7 | change | -16.12 kg | 1.63 | 24 | hypothetical; modified itt; registry:outcomes | |
| 36 | A7 vs A1 | md | -12.84 kg | -16.50 to -9.18 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A7 vs A2 | md | -14.15 kg | -17.77 to -10.54 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A8 | change | -17.18 kg | 1.32 | 43 | hypothetical; modified itt; registry:outcomes | |
| 36 | A8 vs A1 | md | -13.91 kg | -17.10 to -10.71 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A8 vs A2 | md | -15.22 kg | -18.36 to -12.07 | hypothetical; modified itt; registry:outcomes |
HbA1c below 7 percent (16 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 18 | 45 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A2 | responders | 52 | 46 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A3 | responders | 32 | 46 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A4 | responders | 53 | 22 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A5 | responders | 66 | 24 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A6 | responders | 88 | 25 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A7 | responders | 78 | 24 | hypothetical; modified itt; registry:outcomes | ||
| 24 | A8 | responders | 86 | 43 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A1 | responders | 22 | 45 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A2 | responders | 60 | 46 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A3 | responders | 37 | 46 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A4 | responders | 61 | 22 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A5 | responders | 59 | 24 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A6 | responders | 82 | 25 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A7 | responders | 78 | 24 | hypothetical; modified itt; registry:outcomes | ||
| 36 | A8 | responders | 80 | 43 | hypothetical; modified itt; registry:outcomes |
Systolic blood pressure change (14 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | 0.24 mmHg | 2.15 | 45 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 24 | A2 | change | -1.15 mmHg | 2.02 | 46 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 24 | A2 vs A1 | md | -1.39 mmHg | -7.09 to 4.31 | hypothetical; modified itt; R0013029:Supplement Table S4 | ||
| 24 | A3 | change | -4.94 mmHg | 2.00 | 46 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 24 | A3 vs A1 | md | -5.17 mmHg | -10.87 to 0.52 | hypothetical; modified itt; R0013029:Supplement Table S4 | ||
| 24 | A8 | change | -9.19 mmHg | 2.16 | 43 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 24 | A8 vs A1 | md | -9.43 mmHg | -15.35 to -3.51 | hypothetical; modified itt; R0013029:Supplement Table S4 | ||
| 36 | A1 | change | 0.97 mmHg | 2.17 | 45 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 36 | A2 | change | -1.86 mmHg | 2.02 | 46 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 36 | A2 vs A1 | md | -2.83 mmHg | -8.56 to 2.90 | hypothetical; modified itt; R0013029:Supplement Table S4 | ||
| 36 | A3 | change | -2.45 mmHg | 1.92 | 46 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 36 | A3 vs A1 | md | -3.42 mmHg | -9.05 to 2.21 | hypothetical; modified itt; R0013029:Supplement Table S4 | ||
| 36 | A8 | change | -11.22 mmHg | 2.18 | 43 | hypothetical; modified itt; R0013029:Supplement Table S4 | |
| 36 | A8 vs A1 | md | -12.19 mmHg | -18.18 to -6.19 | hypothetical; modified itt; R0013029:Supplement Table S4 |
Acute kidney injury (8 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 45 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A2 | events | 0 / 46 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A3 | events | 0 / 47 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A4 | events | 0 / 23 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A5 | events | 0 / 24 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A6 | events | 0 / 26 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A7 | events | 0 / 24 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A8 | events | 0 / 46 | not stated; safety; acute kidney injury; registry:adverse_events |
All cause mortality (8 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 45 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 46 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 47 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 23 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 24 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 26 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 24 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 46 | not stated; safety; registry:adverse_events |
Heart failure events (8 lines; O23B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 45 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A2 | events | 0 / 46 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A3 | events | 1 / 47 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A4 | events | 1 / 23 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A5 | events | 0 / 24 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A6 | events | 0 / 26 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A7 | events | 0 / 24 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A8 | events | 0 / 46 | not stated; safety; cardiac failure congestive; registry:adverse_events |
Serious adverse events (8 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 45 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 46 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 47 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 23 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 2 / 24 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 2 / 26 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 1 / 24 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 2 / 46 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (8 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 45 | not stated; randomized; registry:flow | ||||
| A2 | events | 0 / 46 | not stated; randomized; registry:flow | ||||
| A3 | events | 1 / 47 | not stated; randomized; registry:flow | ||||
| A4 | events | 0 / 23 | not stated; randomized; registry:flow | ||||
| A5 | events | 0 / 24 | not stated; randomized; registry:flow | ||||
| A6 | events | 0 / 26 | not stated; randomized; registry:flow | ||||
| A7 | events | 0 / 24 | not stated; randomized; registry:flow | ||||
| A8 | events | 2 / 46 | not stated; randomized; registry:flow |
Nausea (8 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 45 | not stated; safety; nausea; registry:adverse_events | ||||
| A2 | events | 8 / 46 | not stated; safety; nausea; registry:adverse_events | ||||
| A3 | events | 2 / 47 | not stated; safety; nausea; registry:adverse_events | ||||
| A4 | events | 2 / 23 | not stated; safety; nausea; registry:adverse_events | ||||
| A5 | events | 6 / 24 | not stated; safety; nausea; registry:adverse_events | ||||
| A6 | events | 7 / 26 | not stated; safety; nausea; registry:adverse_events | ||||
| A7 | events | 10 / 24 | not stated; safety; nausea; registry:adverse_events | ||||
| A8 | events | 9 / 46 | not stated; safety; nausea; registry:adverse_events |
Vomiting (8 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 45 | not stated; safety; vomiting; registry:adverse_events | ||||
| A2 | events | 4 / 46 | not stated; safety; vomiting; registry:adverse_events | ||||
| A3 | events | 1 / 47 | not stated; safety; vomiting; registry:adverse_events | ||||
| A4 | events | 1 / 23 | not stated; safety; vomiting; registry:adverse_events | ||||
| A5 | events | 0 / 24 | not stated; safety; vomiting; registry:adverse_events | ||||
| A6 | events | 2 / 26 | not stated; safety; vomiting; registry:adverse_events | ||||
| A7 | events | 4 / 24 | not stated; safety; vomiting; registry:adverse_events | ||||
| A8 | events | 5 / 46 | not stated; safety; vomiting; registry:adverse_events |
Diarrhea (8 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 45 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A2 | events | 4 / 46 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A3 | events | 1 / 47 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A4 | events | 2 / 23 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A5 | events | 6 / 24 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A6 | events | 5 / 26 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A7 | events | 7 / 24 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A8 | events | 7 / 46 | not stated; safety; diarrhoea; registry:adverse_events |
Constipation (8 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 45 | not stated; safety; constipation; registry:adverse_events | ||||
| A2 | events | 3 / 46 | not stated; safety; constipation; registry:adverse_events | ||||
| A3 | events | 3 / 47 | not stated; safety; constipation; registry:adverse_events | ||||
| A4 | events | 2 / 23 | not stated; safety; constipation; registry:adverse_events | ||||
| A5 | events | 4 / 24 | not stated; safety; constipation; registry:adverse_events | ||||
| A6 | events | 3 / 26 | not stated; safety; constipation; registry:adverse_events | ||||
| A7 | events | 2 / 24 | not stated; safety; constipation; registry:adverse_events | ||||
| A8 | events | 5 / 46 | not stated; safety; constipation; registry:adverse_events |
Gallbladder and biliary disease (8 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 45 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A2 | events | 0 / 46 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 0 / 47 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A4 | events | 0 / 23 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A5 | events | 0 / 24 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A6 | events | 0 / 26 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A7 | events | 1 / 24 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A8 | events | 0 / 46 | not stated; safety; cholecystitis chronic; registry:adverse_events |
Acute pancreatitis (8 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 45 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 46 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A3 | events | 1 / 47 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 23 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 24 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A6 | events | 1 / 26 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 24 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 46 | not stated; safety; pancreatitis acute; registry:adverse_events |