Table 1. Baseline Demographics and Clinical Characteristicsa.
| Characteristic | No. (%) | |
|---|---|---|
| Semaglutide, 2.4 mg (n = 407) | Placebo (n = 204) | |
| Age, mean (SD), y | 46 (13) | 46 (13) |
| Sex | ||
| Women | 315 (77.4) | 180 (88.2) |
| Men | 92 (22.6) | 24 (11.8) |
| Raceb | ||
| White | 307 (75.4) | 158 (77.5) |
| Black or African American | 80 (19.7) | 36 (17.6) |
| Other | 11 (2.7) | 4 (2.0) |
| Asian | 5 (1.2) | 6 (2.9) |
| Native Hawaiian or other Pacific Islander | 3 (0.7) | 0 |
| American Indian or Alaska Native | 1 (0.2) | 0 |
| Hispanic or Latino ethnic group | 75 (18.4) | 46 (22.5) |
| Body weight, mean (SD), kg | 106.9 (22.8) | 103.7 (22.9) |
| Body mass index, mean (SD) | 38.1 (6.7) | 37.8 (6.9) |
| Body mass index categories | ||
| ≥27-<30 (overweight) | 23 (5.7) | 15 (7.4) |
| ≥30-<35 (class 1 obesity) | 126 (31.0) | 58 (28.4) |
| ≥35-<40 (class 2 obesity) | 136 (33.4) | 76 (37.3) |
| ≥40 (class 3 obesity) | 122 (30.0) | 55 (27.0) |
| Waist circumference, mean (SD), cm | 113.6 (15.1) | 111.8 (16.2) |
| Comorbidities at screeningc | ||
| Dyslipidemia | 145 (35.6) | 67 (32.8) |
| Hypertension | 145 (35.6) | 67 (32.8) |
| Knee osteoarthritis | 76 (18.7) | 31 (15.2) |
| Asthma/COPD | 67 (16.5) | 25 (12.3) |
| Obstructive sleep apnea | 58 (14.3) | 19 (9.3) |
| Nonalcoholic fatty liver disease | 23 (5.7) | 12 (5.9) |
| Polycystic ovary syndrome | 17 (5.4) | 10 (5.6) |
| Coronary artery disease | 6 (1.5) | 4 (2.0) |
| No. of comorbidities at screeningc | ||
| None | 99 (24.3) | 49 (24.0) |
| 1 | 93 (22.9) | 53 (26.0) |
| 2 | 96 (23.6) | 43 (21.1) |
| 3 | 62 (15.2) | 38 (18.6) |
| 4 | 31 (7.6) | 14 (6.9) |
| ≥5 | 26 (6.4) | 7 (3.4) |
| Blood pressure, mean (SD), mm Hg | ||
| Systolic | 124 (15) | 124 (15) |
| Diastolic | 80 (10) | 81 (10) |
| Pulse, mean (SD), /min | 71 (10) | 71 (10) |
| Glycated hemoglobin, mean (SD), %d | 5.7 (0.3) | 5.8 (0.3) |
| Fasting plasma glucose, mean (SD), mg/dd | 93.9 (9.4) [n = 397] | 94.0 (9.8) [n = 200] |
| Fasting serum insulin, geometric mean pmol/L (CV)d | 90.1 (59.5) [n = 388] | 92.6 (61.0) [n = 194] |
| C-reactive protein, geometric mean (CV), mg/Ld | 4.52 (142.1) [n = 401] | 4.35 (129.9) [n = 202] |
| Fasting lipid profile, geometric mean (CV), mg/dLe | ||
| Cholesterol | [n = 401] | [n = 202] |
| Total | 185.4 (19.8) | 188.7 (20.6) |
| LDL | 107.7 (30.3) | 111.8 (31.2) |
| HDL | 51.6 (24.0) | 50.9 (22.6) |
| VLDL | 21.0 (49.7) | 21.7 (44.5) |
| Free fatty acids | 11.9 (59.4) [n = 388] | 11.1 (64.8) [n = 195] |
| Triglycerides | 107.9 (50.3) [n = 401] | 110.9 (44.4) [n = 202] |
| Kidney function | ||
| eGFR, geometric mean (CV), mL/min/1.73 m2 | 96.6 (21.3) | 96.5 (20.7) |
| Normal (eGFR ≥90 mL/min/1.73 m2) | 280 (68.8) | 133 (65.2) |
| Mild impairment (eGFR ≥60 –<90 mL/min/1.73 m2) | 118 (29.0) | 66 (32.4) |
| Moderate impairment (eGFR ≥30 –<60 mL/min/1.73 m2) | 9 (2.2) | 5 (2.5) |
| SF-36f | [n = 402] | [n = 203] |
| Physical functioning score | 51.9 (6.7) | 52.1 (6.8) |
| Component summary score | ||
| Physical | 51.6 (6.9) | 51.7 (7.3) |
| Mental | 55.7 (5.3) | 55.4 (6.1) |
Abbreviations: COPD, chronic obstructive pulmonary disease; CV, coefficient of variation (in percentage); eGFR, estimated glomerular filtration rate; HDL, high-density lipoprotein; LDL, low-density lipoprotein; SF-36, 36-Item Short Form Health Survey, Acute Version; VLDL, very low-density lipoprotein.
SI conversion factors: To convert values for glucose to mmol/L, multiply by 0.0555; and cholesterol to mmol/L, multiply by 0.0259. Body mass index is calculated as weight in kilograms divided by height in meters squared.
Body weight, vital signs, and glycated hemoglobin were assessed at screening and randomization; all other laboratory measurements were assessed at randomization only.
Race and ethnicity were determined by the participant according to fixed selection categories with options of “other,” “not applicable,” or “unknown.”
Comorbidities included dyslipidemia, hypertension, coronary artery disease, cerebrovascular disease, obstructive sleep apnea, impaired glucose metabolism, reproductive system disorders, liver disease, kidney disease, osteoarthritis, gout, thyroid disease, and asthma/COPD. Information about comorbidities judged to be relevant and significant for the trial population was collected at screening, using specific disease forms based on information from the participants (yes/no answers).
Normal value for glycated hemoglobin is <6.5%; for fasting plasma glucose, 74-99 mg/dL; for fasting serum insulin, 11-220 pmol/L (in women) and <218 pmol/L (in men); for C-reactive protein, <5 mg/L.
Normal values: total cholesterol, <199.6 mg/dL; LDL, <99.2 mg/dL; HDL, >59.9 mg/dL; VLDL, <30.1 mg/dL; free fatty acids, 2.8-25.4 mg/dL; and triglycerides, <150.4 mg/dL.
SF-36 is a measure of health-related quality of life and general health status. It uses a norm-based score: greater than and less than 50 are greater than and less than the average, respectively, found in the 2009 US general population. Further information on the SF-36 is provided in eAppendix 7 in Supplement 1.