parallel randomized trial
S003138
Other conditionsS003138
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | lifestyle: not reported | 12 | 12 | |
| A2 | GLP-1-gFc GLP-1-gFc 0.01 mg/kg | lifestyle: not reported | 6 | 6 | |
| A3 | GLP-1-gFc GLP-1-gFc 0.02 mg/kg | lifestyle: not reported | 6 | 6 | |
| A4 | GLP-1-gFc GLP-1-gFc 0.04 mg/kg | lifestyle: not reported | 6 | 6 | |
| A5 | GLP-1-gFc GLP-1-gFc 0.08 mg/kg | lifestyle: not reported | 6 | 6 | |
| A6 | GLP-1-gFc GLP-1-gFc 0.16 mg/kg | lifestyle: not reported | 6 | 6 | |
| A7 | GLP-1-gFc GLP-1-gFc 0.24 mg/kg | lifestyle: not reported | 6 | 6 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | GLP-1-gFc 0.01 mg/kg A2 | GLP-1-gFc 0.02 mg/kg A3 | GLP-1-gFc 0.04 mg/kg A4 | GLP-1-gFc 0.08 mg/kg A5 | GLP-1-gFc 0.16 mg/kg A6 | GLP-1-gFc 0.24 mg/kg A7 | Whole trial ALL |
|---|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 27.5 | 33.3 | 26.8 | 29.2 | 34.7 | 25.0 | 31.4 | |
| age | sd (years) | 7.1 | 3.6 | 7.3 | 3.5 | 4.6 | 4.0 | 5.0 | |
| asian | n | 1 | |||||||
| black | n | 1 | |||||||
| bmi | mean (kg/m2) | 23.43 | 23.03 | 24.65 | 25.93 | 25.80 | 23.53 | 25.78 | |
| bmi | sd (kg/m2) | 3.19 | 3.38 | 2.58 | 3.63 | 2.06 | 4.12 | 2.84 | |
| other male | n | 48 | |||||||
| weight | mean (kg) | 73.2 | 74.4 | 77.3 | 87.1 | 78.9 | 75.3 | 83.3 | |
| weight | sd (kg) | 6.9 | 9.4 | 11.3 | 14.9 | 6.3 | 12.3 | 8.4 | |
| white | n | 46 |
Results
25 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Nausea (7 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 12 | not stated; randomized; R0008337:Figure 6D | ||||
| A2 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A3 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A4 | events | 1 / 6 | not stated; randomized; R0008337:Results | ||||
| A5 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A6 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A7 | events | 4 / 6 | not stated; randomized; R0008337:Results |
Vomiting (7 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 12 | not stated; randomized; R0008337:Figure 6D | ||||
| A2 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A3 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A4 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A5 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A6 | events | 0 / 6 | not stated; randomized; R0008337:Figure 6D | ||||
| A7 | events | 1 / 6 | not stated; randomized; R0008337:Results |
Diarrhea (7 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 12 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A2 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A3 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A4 | events | 1 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A5 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A6 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A7 | events | 2 / 6 | not stated; randomized; R0008337:Supplement Table S2 |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A3 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A5 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 | ||||
| A6 | events | 0 / 6 | not stated; randomized; R0008337:Supplement Table S2 |