parallel randomized trial
XW003
A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XW003 Injection in Healthy Adult Participants
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | ecnoglutide Ecnoglutide 0.2 mg MAD | lifestyle: not reported | 8 | 8 | |
| A10 | Placebo Pooled placebo single dose | lifestyle: not reported | 9 | ||
| A2 | ecnoglutide Ecnoglutide 0.4 mg MAD | lifestyle: not reported | 8 | 8 | |
| A3 | ecnoglutide Ecnoglutide 0.6 mg MAD | lifestyle: not reported | 7 | 7 | |
| A4 | Placebo Pooled placebo MAD | lifestyle: not reported | 5 | 5 | |
| A5 | ecnoglutide Ecnoglutide 0.1 mg single dose | lifestyle: not reported | 6 | ||
| A6 | ecnoglutide Ecnoglutide 0.2/0.25 mg single dose | lifestyle: not reported | 6 | ||
| A7 | ecnoglutide Ecnoglutide 0.4/0.5 mg single dose | lifestyle: not reported | 6 | ||
| A8 | ecnoglutide Ecnoglutide 0.8/1.0 mg single dose | lifestyle: not reported | 1 | ||
| A9 | ecnoglutide Ecnoglutide 0.6 mg single dose | lifestyle: not reported | 6 |
Results
48 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Serious adverse events (10 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 8 | not stated; safety; R0009494:Results | ||||
| A10 | events | 0 / 9 | not stated; safety; R0009494:Results | ||||
| A2 | events | 0 / 8 | not stated; safety; R0009494:Results | ||||
| A3 | events | 0 / 7 | not stated; safety; R0009494:Results | ||||
| A4 | events | 0 / 5 | not stated; safety; R0009494:Results | ||||
| A5 | events | 0 / 6 | not stated; safety; R0009494:Results | ||||
| A6 | events | 0 / 6 | not stated; safety; R0009494:Results | ||||
| A7 | events | 0 / 6 | not stated; safety; R0009494:Results | ||||
| A8 | events | 0 / 1 | not stated; safety; R0009494:Results | ||||
| A9 | events | 0 / 6 | not stated; safety; R0009494:Results |
Discontinuation due to adverse events (10 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 8 | not stated; safety; R0009494:Supplement Figure S4B | ||||
| A10 | events | 0 / 9 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A2 | events | 0 / 8 | not stated; safety; R0009494:Supplement Figure S4B | ||||
| A3 | events | 0 / 7 | not stated; safety; R0009494:Supplement Figure S4B | ||||
| A4 | events | 1 / 5 | not stated; safety; likely viral gastroenteritis; R0009494:Supplement Figure S4B | ||||
| A5 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A6 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A7 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A8 | events | 0 / 1 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A9 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 8 | not stated; safety; R0009494:Supplement Table S4 | ||||
| A2 | events | 2 / 8 | not stated; safety; R0009494:Supplement Table S4 | ||||
| A3 | events | 5 / 7 | not stated; safety; R0009494:Supplement Table S4 | ||||
| A4 | events | 0 / 5 | not stated; safety; R0009494:Supplement Table S4 |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 8 | not stated; safety; R0009494:Supplement Table S4 | ||||
| A2 | events | 1 / 8 | not stated; safety; R0009494:Supplement Table S4 | ||||
| A3 | events | 3 / 7 | not stated; safety; R0009494:Supplement Table S4 | ||||
| A4 | events | 0 / 5 | not stated; safety; R0009494:Supplement Table S4 |
Discontinuation due to gastrointestinal adverse events (10 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 8 | not stated; safety; R0009494:Supplement Figure S4B | ||||
| A10 | events | 0 / 9 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A2 | events | 0 / 8 | not stated; safety; R0009494:Supplement Figure S4B | ||||
| A3 | events | 0 / 7 | not stated; safety; R0009494:Supplement Figure S4B | ||||
| A4 | events | 0 / 5 | not stated; safety; R0009494:Supplement Figure S4B | ||||
| A5 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A6 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A7 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A8 | events | 0 / 1 | not stated; safety; R0009494:Supplement Figure S4A | ||||
| A9 | events | 0 / 6 | not stated; safety; R0009494:Supplement Figure S4A |
Death by suicide (10 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 8 | not stated; safety; R0009494:Results | ||||
| A10 | events | 0 / 9 | not stated; safety; R0009494:Results | ||||
| A2 | events | 0 / 8 | not stated; safety; R0009494:Results | ||||
| A3 | events | 0 / 7 | not stated; safety; R0009494:Results | ||||
| A4 | events | 0 / 5 | not stated; safety; R0009494:Results | ||||
| A5 | events | 0 / 6 | not stated; safety; R0009494:Results | ||||
| A6 | events | 0 / 6 | not stated; safety; R0009494:Results | ||||
| A7 | events | 0 / 6 | not stated; safety; R0009494:Results | ||||
| A8 | events | 0 / 1 | not stated; safety; R0009494:Results | ||||
| A9 | events | 0 / 6 | not stated; safety; R0009494:Results |