Table 2.
Assessment of efficacy parameters and safety profile by BW reduction categories
| BW reduction % (week 40/42) | ||||
|---|---|---|---|---|
| <5% (n = 756) | ≥5 to <10% (n = 878) | ≥10 to <15% (n = 762) | ≥15% (n = 792) | |
| HbA1c, % | −1.9 ± 1.2 | −2.3 ± 1.1 | −2.5 ± 1.0 | −2.6 ± 0.9 |
| Participants reaching HbA1c | ||||
| <7% | 548 (72.9) | 788 (89.9) | 724 (95.3) | 778 (98.5) |
| ≤6.5% | 415 (55.2) | 705 (80.4) | 698 (91.8) | 761 (96.3) |
| <5.7% | 93 (12.4) | 243 (27.7) | 347 (45.7) | 510 (64.6) |
| Fasting serum glucose, mg/dL | −46.0 ± 55.4 | −58.1 ± 49.4 | −65.7 ± 49.7 | −66.6 ± 45.3 |
| Weight, kg (%) | −1.7 ± 2.6 (−2) | −7.1 ± 2.1 (−8) | −11.3 ± 2.6 (−12) | −18.5 ± 6.0 (−20) |
| BMI, kg/m2 | −0.6 ± 0.9 | −2.5 ± 0.7 | −4.1 ± 0.9 | −6.9 ± 2.1 |
| Waist circumference, cm | −2.4 ± 7.3 | −6.4 ± 6.8 | −9.5 ± 7.5 | −15.1 ± 9.0 |
| Systolic blood pressure, mmHg | −2.4 ± 13.0 | −4.6 ± 14.1 | −6.8 ± 14.4 | −10.3 ± 15.8 |
| Diastolic blood pressure, mmHg | −0.8 ± 8.4 | −1.7 ± 8.8 | −2.7 ± 9.1 | −4.3 ± 9.9 |
| eGFR, mL/min/1.73 m2 | −4.7 ± 10.0 | −3.8 ± 9.9 | −3.2 ± 11.0 | −3.2 ± 12.2 |
| Total cholesterol, % | −0.1 ± 21.0 | −5.1 ± 21.1 | −4.6 ± 21.2 | −6.8 ± 20.2 |
| Non-HDL cholesterol, % | −0.7 ± 28.7 | −8.1 ± 28.0 | −8.4 ± 29.0 | −12.2 ± 27.2 |
| HDL cholesterol, % | 4.7 ± 20.0 | 7.2 ± 18.1 | 9.5 ± 18.7 | 11.5 ± 19.3 |
| LDL cholesterol, % | 1.8 ± 39.2 | −1.9 ± 46.8 | −0.3 ± 41.6 | −3.6 ± 41.8 |
| Triglycerides, % | 1.9 ± 45.4 | −11.7 ± 40.9 | −17.9 ± 37.3 | −24.2 ± 33.3 |
| ALT, % | −4.5 ± 43.2 | −14.6 ± 41.7 | −23.4 ± 38.9 | −22.1 ± 70.8 |
| AST, % | 2.2 ± 37.4 | −4.5 ± 34.5 | −8.9 ± 33.9 | −8.6 ± 53.8 |
| Participants with ≥1 serious adverse event | 32 (4.2) | 37 (4.2) | 30 (3.9) | 31 (3.9) |
| Participants with ≥1 TEAE | 420 (55.6) | 515 (58.7) | 470 (61.7) | 540 (68.2) |
| TEAEs occurring in ≥5% of participants in any BW reduction category by preferred term | ||||
| Nausea | 77 (10.2) | 128 (14.6) | 123 (16.1) | 183 (23.1) |
| Diarrhea | 103 (13.6) | 112 (12.8) | 103 (13.5) | 128 (16.2) |
| Decreased appetite | 27 (3.6) | 60 (6.8) | 65 (8.5) | 85 (10.7) |
| Dyspepsia | 47 (6.2) | 49 (5.6) | 58 (7.6) | 55 (6.9) |
| Vomiting | 30 (4.0) | 37 (4.2) | 44 (5.8) | 65 (8.2) |
Data are mean ± SD change, n (%), or percentage change from baseline at week 40/42, unless otherwise noted, with n indicating pooled number of participants across SURPASS-1 through SURPASS-4 tirzepatide doses Percentage change in BW is presented in parenthesis. Lipid data are percentage change from baseline. Note: Waist circumference data for SURPASS-4 were not available at weeks 40/42 so week 36 measures were used.