Table 1.
Schedule of events.
|
|
Screening | Intervention start, T=0 week | T + 3 weeks (±7 days) | T + 7 weeks (±7 days) | T + 11 weeks (±7 days) | T + 20 weeks (±7 days) | T + 20 weeks (±7 days) | T + 21 weeks (± 7 days) |
| Visit | V1 | V2 | V3 | V4 | V5 | V6aa | V6ba | V7 |
| Medical history and physical exam | X |
|
|
|
|
X |
|
|
| Vitals, anthropometric measurements | X | X | X | X | X | X | X |
|
| Clinical labs | X |
|
|
|
|
X |
|
|
| Randomization |
|
X |
|
|
|
|
|
|
| DXAb scan | X |
|
|
|
|
X |
|
|
| ECGc | X |
|
|
|
|
|
|
|
| SPPBd, grip strength, 6-minute walk | X |
|
|
|
|
X |
|
|
| Surveys (SF-12e, CNAQf) | X |
|
|
|
|
X |
|
|
| Blood, muscle, and adipose biopsy |
|
X |
|
|
|
|
X |
|
| Start of semaglutide for treatment group |
|
X |
|
|
|
|
|
|
| Semaglutide dispensed to treatment group |
|
X | X | X | X |
|
|
|
| Lifestyle education |
|
X | X | X | X |
|
|
|
| Assessment of adverse events |
|
X | X | X | X | X | X | X |
aVisits 6a and 6b are the end-of-study visits but are split into 2 visits.
bDXA: dual-energy x-ray absorptiometry.
cECG: electrocardiogram.
dSPPB: short physical performance battery.
eSF-12: Short-Form 12.
fCNAQ: The Council on Nutrition Appetite Questionnaire.