parallel randomized trial
ESSENCE
The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg once weekly | standard of care for MASH; lifestyle: not reported | 534 | ||
| A2 | Placebo Placebo once weekly | standard of care for MASH; lifestyle: not reported | 266 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 2.4 mg subcutaneous once weekly A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 56.0 | ||
| age | sd (years) | 11.6 | ||
| bmi | mean (kg/m2) | 34.6 | ||
| bmi | sd (kg/m2) | 7.2 | ||
| female | percent | 57.1 | ||
| waist | mean (cm) | 100.2 | 100.8 | |
| waist | sd (cm) | 13.8 | 14.3 | |
| weight | mean (kg) | 77.7 | 78.0 | |
| weight | sd (kg) | 20.3 | 17.5 |
Results
19 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Health related quality of life total score (any instrument) (6 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | change | 0.03 utility | 0.01 | 296 | treatment policy; full analysis; diabetes:t2d; R0013433:Table 1 | |
| 72 | A1 | change | 0.03 utility | 0.01 | 534 | treatment policy; full analysis; R0013433:Table 1 | |
| 72 | A1 vs A2 | md | 0.03 utility | 0.01 to 0.06 | treatment policy; full analysis; R0013433:Table 1 | ||
| 72 | A1 vs A2 | md | 0.04 utility | 0.01 to 0.07 | treatment policy; full analysis; diabetes:t2d; R0013433:Table 1 | ||
| 72 | A2 | change | -0.01 utility | 0.01 | 266 | treatment policy; full analysis; R0013433:Table 1 | |
| 72 | A2 | change | -0.01 utility | 0.01 | 151 | treatment policy; full analysis; diabetes:t2d; R0013433:Table 1 |
Nausea (1 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 36.2 | not stated; safety; R0012908:p7 |
Resolution of steatohepatitis without worsening of fibrosis (6 lines; O60)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | responders | 63.1 | 78 | treatment policy; full analysis; region:japan; R0012908:Results | ||
| 72 | A1 | responders | 62.9 | 534 | treatment policy; full analysis; R0012908:p2 | ||
| 72 | A1 vs A2 | rd | 28.65 | 21.09 to 36.21 | treatment policy; full analysis; R0012908:p5 | ||
| 72 | A1 vs A2 | rd | 26.65 | 7.43 to 45.86 | treatment policy; full analysis; region:japan; R0012908:Results | ||
| 72 | A2 | responders | 34.3 | 266 | treatment policy; full analysis; R0012908:p2 | ||
| 72 | A2 | responders | 36.8 | 38 | treatment policy; full analysis; region:japan; R0012908:Results |
Fibrosis improvement without worsening of steatohepatitis (6 lines; O61)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 72 | A1 | responders | 36.8 | 534 | treatment policy; full analysis; R0012908:p2 | ||
| 72 | A1 vs A2 | rd | 14.39 | 7.51 to 21.27 | treatment policy; full analysis; R0012908:p7 | ||
| 72 | A1 | responders | 36.5 | 78 | treatment policy; full analysis; region:japan; R0012908:Results | ||
| 72 | A1 vs A2 | rd | 7.07 | -11.48 to 25.62 | treatment policy; full analysis; region:japan; R0012908:Results | ||
| 72 | A2 | responders | 22.4 | 266 | treatment policy; full analysis; R0012908:p2 | ||
| 72 | A2 | responders | 28.9 | 38 | treatment policy; full analysis; region:japan; R0012908:Results |