parallel randomized trial
S003048
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 0.5 mg subcutaneous once weekly Ketogenic VLED then semaglutide | 12 week ketogenic VLED with meal replacements, then energy controlled diet; lifestyle: intensive | 14 | ||
| A2 | Lifestyle intervention (randomized arm) Mediterranean diet | lifestyle: standard | 11 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 0.5 mg subcutaneous once weekly A1 | Lifestyle intervention (randomized arm) A2 | Whole trial ALL |
|---|---|---|---|---|
| age | median (years) | 45 | 50 | |
| age | q1 (years) | 35 | 44 | |
| age | q3 (years) | 59 | 57 | |
| bmi | mean (kg/m2) | 31.2 | 32.3 | |
| bmi | sd (kg/m2) | 3.2 | 3.1 | |
| fibrosis stage: f1 to f2 | n | 12 | 11 | |
| fibrosis stage: f1 to f2 | percent | 92 | 100 | |
| fibrosis stage: f3 to f4 | n | 1 | 0 | |
| fibrosis stage: f3 to f4 | percent | 8 | ||
| other male | n | 9 | 5 | |
| other male | percent | 64 | 45 | |
| other race central south asian | n | 5 | 0 | |
| other race central south asian | percent | 36 | 0 | |
| other race native hawaiian pacific islander | n | 0 | 1 | |
| other race native hawaiian pacific islander | percent | 0 | 9 | |
| other race white oceanian | n | 7 | 8 | |
| other race white oceanian | percent | 50 | 73 | |
| other race white south east european | n | 2 | 2 | |
| other race white south east european | percent | 14 | 18 | |
| waist sex:female | mean (cm) | 107.7 | 109.4 | |
| waist sex:female | sd (cm) | 10.0 | 6.2 | |
| waist sex:male | mean (cm) | 105.6 | 114.6 | |
| waist sex:male | sd (cm) | 8.3 | 7.3 | |
| weight | mean (kg) | 90.4 | 93.9 | |
| weight | sd (kg) | 13.1 | 14.5 | |
| white | n | 19 | ||
| white | percent | 76 |