Table 1.
Prevalence of patients meeting the criteria for metabolic syndrome in the SURPASS clinical trial program
| Metabolic Syndrome Risk Factors | Tirzepatide 5 mg | Tirzepatide 10 mg | Tirzepatide 15 mg | Comparator | ||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Primary Endpoint | Baseline | Primary Endpoint | Baseline | Primary Endpoint | Baseline | Primary Endpoint | |
| SURPASS-1 monotherapy, N | 105 | 103 | 93 | 95 | ||||
| ≥ 3 Risk Factors | 77 (73.3) | 58 (55.2) | 69 (67.0) | 49 (47.6) | 70 (75.3) | 36 (38.7) | 73 (76.8) | 68 (71.6) |
| WC > 102 cm (M), > 89 cm (F) | 76 (72.4) | 63 (60.0) | 67 (65.0) | 47 (45.6) | 61 (65.6) | 46 (49.5) | 64 (67.4) | 61 (64.2) |
| FSG ≥ 100 mg/dL or HbA1c ≥ 5.7% | 105 (100.0) | 83 (79.0) | 103 (100.0) | 84 (81.6) | 93 (100.0) | 60 (64.5) | 95 (100.0) | 94 (98.9) |
| SBP > 130 mmHg or DBP > 85 mmHg | 50 (47.6) | 40 (38.1) | 45 (43.7) | 29 (28.2) | 44 (47.3) | 26 (28.0) | 41 (43.2) | 41 (43.2) |
| Triglycerides > 150 mg/dL | 52 (49.5) | 37 (35.2) | 52 (50.5) | 31 (30.1) | 45 (48.4) | 23 (24.7) | 53 (55.8) | 48 (50.5) |
| HDL < 40 mg/dL (M), < 50 mg/dL (F) | 62 (59.0) | 53 (50.5) | 51 (49.5) | 50 (48.5) | 55 (59.1) | 47 (50.5) | 55 (57.9) | 56 (58.9) |
| SURPASS-2 add-on to MET vs SEMA 1 mg, N | 415 | 387 | 389 | 414 | ||||
| ≥ 3 Risk Factors | 341 (82.2) | 227 (54.7) | 336 (86.8) | 199 (51.4) | 328 (84.3) | 161 (41.4) | 344 (83.1) | 266 (64.3) |
| WC > 102 cm (M), > 89 cm (F) | 345 (83.1) | 272 (65.5) | 326 (84.2) | 244 (63.0) | 326 (83.8) | 234 (60.2) | 349 (84.3) | 278 (67.1) |
| FSG ≥ 100 mg/dL or HbA1c ≥ 5.7% | 415 (100.0) | 345 (83.1) | 387 (100.0) | 263 (68.0) | 389 (100.0) | 235 (60.4) | 414 (100.0) | 358 (86.5) |
| SBP > 130 mmHg or DBP > 85 mmHg | 230 (55.4) | 165 (39.8) | 244 (63.0) | 148 (38.2) | 206 (53.0) | 139 (35.7) | 234 (56.5) | 187 (45.2) |
| Triglycerides > 150 mg/dL | 227 (54.7) | 159 (38.3) | 211 (54.5) | 132 (34.1) | 209 (53.7) | 120 (30.8) | 225 (54.3) | 193 (46.6) |
| HDL < 40 mg/dL (M), < 50 mg/dL (F) | 230 (55.4) | 183 (44.1) | 216 (55.8) | 170 (43.9) | 229 (58.9) | 176 (45.2) | 239 (57.7) | 201 (48.6) |
| SURPASS-3 add-on to MET ± SGLT2i vs iDeg, N | 308 | 291 | 292 | 313 | ||||
| ≥ 3 Risk Factors | 245 (79.5) | 184 (59.7) | 249 (85.6) | 139 (47.8) | 249 (85.3) | 145 (49.7) | 242 (77.3) | 248 (79.2) |
| WC > 102 cm (M), > 89 cm (F) | 255 (82.8) | 212 (68.8) | 248 (85.2) | 170 (58.4) | 252 (86.3) | 173 (59.2) | 253 (80.8) | 263 (84.0) |
| FSG ≥ 100 mg/dL or HbA1c ≥ 5.7% | 308 (100.0) | 269 (87.3) | 291 (100.0) | 220 (75.6) | 292 (100.0) | 211 (72.3) | 313 (100.0) | 297 (94.9) |
| SBP > 130 mmHg or DBP > 85 mmHg | 185 (60.1) | 131 (42.5) | 173 (59.5) | 109 (37.5) | 180 (61.6) | 112 (38.4) | 201 (64.2) | 192 (61.3) |
| Triglycerides > 150 mg/dL | 166 (53.9) | 120 (39.0) | 155 (53.3) | 91 (31.3) | 163 (55.8) | 101 (34.6) | 155 (49.5) | 129 (41.2) |
| HDL < 40 mg/dL (M), < 50 mg/dL (F) | 153 (49.7) | 135 (43.8) | 171 (58.8) | 118 (40.5) | 163 (55.8) | 125 (42.8) | 154 (49.2) | 150 (47.9) |
| SURPASS-4 ± MET ± SGLT2i ± SU vs iGlar, N | 273 | 276 | 274 | 870 | ||||
| ≥ 3 Risk Factors | 227 (83.2) | 159 (58.2) | 242 (87.7) | 163 (59.1) | 237 (86.5) | 141 (51.5) | 727 (83.6) | 717 (82.4) |
| WC > 102 cm (M), > 89 cm (F) | 222 (81.3) | 174 (63.7) | 227 (82.2) | 163 (59.1) | 226 (82.5) | 158 (57.7) | 674 (77.5) | 709 (81.5) |
| FSG ≥ 100 mg/dL or HbA1c ≥ 5.7% | 273 (100.0) | 227 (83.2) | 276 (100.0) | 227 (82.2) | 274 (100.0) | 193 (70.4) | 869 (99.9) | 843 (96.9) |
| SBP > 130 mmHg or DBP > 85 mmHg | 169 (61.9) | 134 (49.1) | 180 (65.2) | 155 (56.2) | 179 (65.3) | 138 (50.4) | 590 (64.4) | 609 (70.0) |
| Triglycerides > 150 mg/dL | 154 (56.4) | 112 (41.0) | 146 (52.9) | 92 (33.3) | 151 (55.1) | 92 (33.6) | 451 (51.8) | 416 (47.8) |
| HDL < 40 mg/dL (M), < 50 mg/dL (F) | 156 (57.1) | 130 (47.6) | 182 (65.9) | 130 (47.1) | 168 (61.3) | 124 (45.3) | 509 (58.5) | 466 (53.6) |
| SURPASS-5 add-on to insulin glargine ± MET vs PBO, N | 105 | 105 | 98 | 113 | ||||
| ≥ 3 Risk Factors | 84 (80.0) | 67 (63.8) | 83 (79.0) | 55 (52.4) | 76 (77.6) | 37 (37.8) | 90 (79.6) | 90 (79.6) |
| WC > 102 cm (M), > 89 cm (F) | 92 (87.6) | 79 (75.2) | 87 (82.9) | 76 (72.4) | 81 (82.7) | 69 (70.4) | 90 (79.6) | 92 (81.4) |
| FSG ≥ 100 mg/dL or HbA1c ≥ 5.7% | 105 (100.0) | 84 (80.0) | 105 (100.0) | 68 (64.8) | 98 (100.0) | 54 (55.1) | 113 (100.0) | 110 (97.3) |
| SBP > 130 mmHg or DBP > 85 mmHg | 73 (69.5) | 59 (56.2) | 78 (74.3) | 55 (52.4) | 69 (70.4) | 31 (31.6) | 84 (74.3) | 80 (70.8) |
| Triglycerides > 150 mg/dL | 48 (45.7) | 33 (31.4) | 52 (49.5) | 31 (29.5) | 37 (37.8) | 17 (17.3) | 48 (42.5) | 44 (38.9) |
| HDL < 40 mg/dL (M), < 50 mg/dL (F) | 53 (50.5) | 47 (44.8) | 45 (42.9) | 39 (37.1) | 43 (43.9) | 40 (40.8) | 46 (40.7) | 46 (40.7) |
Data are n (%) at baseline and at the primary endpoint of 40 weeks (SURPASS-1, SURPASS-2 and SURPASS-5) or 52 weeks (SURPASS-3, SURPASS-4) in patients on-treatment compliant to study drug (patients taking ≥ 75% of assigned doses)
DBP: diastolic blood pressure; F: female; FSG: fasting serum glucose; HbA1c: glycated hemoglobin; HDL: high-density lipoprotein; iDeg: insulin degludec; iGlar: insulin glargine; M: male; MET: metformin; n: number of patients in the specified category; PBO: placebo; SBP: systolic blood pressure; SEMA: semaglutide; SGLT2i: sodium glucose cotransporter 2 inhibitor; SU: sulfonylurea; WC: waist circumference