crossover randomized trial
NCT06440980
A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | orforglipron Orforglipron 1 mg capsule | lifestyle: not reported | 216 | 215 | |
| A10 | orforglipron Orforglipron 14.5 mg tablet | lifestyle: not reported | 213 | 180 | |
| A11 | Orforglipron 36 mg oral once daily Orforglipron 36 mg capsule | lifestyle: not reported | 213 | 176 | |
| A12 | orforglipron Orforglipron 17.2 mg tablet | lifestyle: not reported | 213 | 176 | |
| A2 | orforglipron Orforglipron 0.8 mg tablet | lifestyle: not reported | 216 | 213 | |
| A3 | Orforglipron 3 mg oral once daily Orforglipron 3 mg capsule | lifestyle: not reported | 216 | 210 | |
| A4 | orforglipron Orforglipron 2.5 mg tablet | lifestyle: not reported | 216 | 210 | |
| A5 | Orforglipron 6 mg oral once daily Orforglipron 6 mg capsule | lifestyle: not reported | 216 | 203 | |
| A6 | orforglipron Orforglipron 5.5 mg tablet | lifestyle: not reported | 216 | 203 | |
| A7 | Orforglipron 12 mg oral once daily Orforglipron 12 mg capsule | lifestyle: not reported | 213 | 186 | |
| A8 | orforglipron Orforglipron 9 mg tablet | lifestyle: not reported | 213 | 186 | |
| A9 | Orforglipron 24 mg oral once daily Orforglipron 24 mg capsule | lifestyle: not reported | 213 | 181 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Orforglipron 1 mg capsule A1 | Orforglipron 0.8 mg tablet A2 | Orforglipron 3 mg oral once daily A3 | Orforglipron 2.5 mg tablet A4 | Orforglipron 6 mg oral once daily A5 | Orforglipron 5.5 mg tablet A6 | Orforglipron 12 mg oral once daily A7 | Orforglipron 9 mg tablet A8 | Orforglipron 24 mg oral once daily A9 | Orforglipron 14.5 mg tablet A10 | Orforglipron 36 mg oral once daily A11 | Orforglipron 17.2 mg tablet A12 | Whole trial ALL |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 43.4 | ||||||||||||
| age | sd (years) | 10.9 | ||||||||||||
| asian | n | 7 | ||||||||||||
| asian | percent | 1.6 | ||||||||||||
| black | n | 180 | ||||||||||||
| black | percent | 42.0 | ||||||||||||
| bmi | mean (kg/m2) | 31.7 | ||||||||||||
| bmi | sd (kg/m2) | 3.2 | ||||||||||||
| female | n | 175 | ||||||||||||
| female | percent | 40.8 | ||||||||||||
| hispanic | n | 119 | ||||||||||||
| hispanic | percent | 27.7 | ||||||||||||
| other race american indian alaska native | n | 7 | ||||||||||||
| other race american indian alaska native | percent | 1.6 | ||||||||||||
| other race multiple | n | 6 | ||||||||||||
| other race multiple | percent | 1.4 | ||||||||||||
| other race native hawaiian pacific islander | n | 1 | ||||||||||||
| other race native hawaiian pacific islander | percent | 0.2 | ||||||||||||
| white | n | 227 | ||||||||||||
| white | percent | 52.9 |
Results
84 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
All cause mortality (12 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 215 | not stated; safety; registry:adverse_events | ||||
| A10 | events | 0 / 180 | not stated; safety; registry:adverse_events | ||||
| A11 | events | 0 / 176 | not stated; safety; registry:adverse_events | ||||
| A12 | events | 0 / 176 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 213 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 210 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 210 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 203 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 203 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 186 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 186 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 181 | not stated; safety; registry:adverse_events |
Serious adverse events (12 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 215 | not stated; safety; registry:adverse_events | ||||
| A10 | events | 0 / 180 | not stated; safety; registry:adverse_events | ||||
| A11 | events | 1 / 176 | not stated; safety; registry:adverse_events | ||||
| A12 | events | 0 / 176 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 213 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 210 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 210 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 203 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 1 / 203 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 186 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 186 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 181 | not stated; safety; registry:adverse_events |
Nausea (12 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 215 | not stated; safety; registry:adverse_events | ||||
| A10 | events | 15 / 180 | not stated; safety; registry:adverse_events | ||||
| A11 | events | 9 / 176 | not stated; safety; registry:adverse_events | ||||
| A12 | events | 6 / 176 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 7 / 213 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 29 / 210 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 13 / 210 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 19 / 203 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 17 / 203 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 32 / 186 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 12 / 186 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 31 / 181 | not stated; safety; registry:adverse_events |
Vomiting (12 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 215 | not stated; safety; registry:adverse_events | ||||
| A10 | events | 9 / 180 | not stated; safety; registry:adverse_events | ||||
| A11 | events | 19 / 176 | not stated; safety; registry:adverse_events | ||||
| A12 | events | 10 / 176 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 213 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 16 / 210 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 7 / 210 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 15 / 203 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 10 / 203 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 22 / 186 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 15 / 186 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 17 / 181 | not stated; safety; registry:adverse_events |
Diarrhea (12 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 215 | not stated; safety; registry:adverse_events | ||||
| A10 | events | 12 / 180 | not stated; safety; registry:adverse_events | ||||
| A11 | events | 11 / 176 | not stated; safety; registry:adverse_events | ||||
| A12 | events | 4 / 176 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 213 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 7 / 210 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 3 / 210 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 3 / 203 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 3 / 203 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 19 / 186 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 5 / 186 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 23 / 181 | not stated; safety; registry:adverse_events |
Constipation (12 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 58 / 215 | not stated; safety; registry:adverse_events | ||||
| A10 | events | 6 / 180 | not stated; safety; registry:adverse_events | ||||
| A11 | events | 8 / 176 | not stated; safety; registry:adverse_events | ||||
| A12 | events | 5 / 176 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 19 / 213 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 20 / 210 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 13 / 210 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 15 / 203 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 10 / 203 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 39 / 186 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 17 / 186 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 19 / 181 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (12 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 215 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A10 | events | 0 / 180 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A11 | events | 0 / 176 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A12 | events | 0 / 176 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 213 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 210 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 210 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A5 | events | 1 / 203 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A6 | events | 0 / 203 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 186 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 186 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A9 | events | 0 / 181 | not stated; safety; cholecystitis acute; registry:adverse_events |