Table 4.
Key information of the SURPASS 1–6 clinical trials with the glucose-lowering dual GIP/GLP-1 receptor agonist tirzepatide
| Study name | Clinicaltrials.gov ID | Study status | n | Key inclusion criteria | Key exclusion criteria | Intervention | Adjunctive therapy |
|---|---|---|---|---|---|---|---|
|
SURPASS-1 [38] |
NCT03954834 | Completed | 478 | Naive to diabetes injectable therapies, HbA1c 7.0–9.5%, BMI ≥ 23 kg/m2 at screening | Use of any oral antihyperglycemic medications for 3 months before screening, eGFR < 30 ml/min/1.73m2 | Tirzepatide 5, 10, or 15 mg SC once a week vs. placebo | None |
|
SURPASS-2 [39] |
NCT03987919 | Completed | 1879 |
HbA1c 7.0–10.5%, BMI ≥ 25 kg/m2 at screening Stable background medications (metformin) |
eGFR < 45 ml/min/1.73m2 | Tirzepatide 5, 10, or 15 mg SC once a week vs. semaglutide 1 mg once a week | Metformin |
|
SURPASS-3 [40] |
NCT03882970 | Completed | 1444 |
HbA1c 7.0–10.5%, BMI ≥ 25 kg/m2 at screening Stable background medications (metformin ± SGLT2i) |
eGFR < 45 ml/min/1.73m2 Other medications than metformin ± SGLT2i |
Tirzepatide 5, 10, or 15 mg SC once a week vs. insulin degludec SC once a day | Metformin or metformin + SGLT2i |
|
SURPASS-4 [41] |
NCT03730662 | Completed | 2002 |
HbA1c 7.0–10.5%, BMI ≥ 25 kg/m2 at screening Increased risk of CV events Stable background medications (metformin ± sulfonylurea or SGLT2i) |
Other medications than metformin ± sulfonylurea or SGLT2i | Tirzepatide 5, 10, or 15 mg SC once a week vs. insulin glargine SC once a day | Metformin or metformin + sulfonylurea or SGLT2i |
|
SURPASS-5 [42] |
NCT04039503 | Completed | 457 |
HbA1c 7.0–10.5%, BMI ≥ 23 kg/m2 at screening Stable background medications (insulin glargine (U100) ± metformin) |
eGFR < 30 ml/min/1.73m2 (< 45 if treated with metformin) | Tirzepatide 5, 10, or 15 mg SC once a week vs. placebo | Insulin glargine or insulin glargine + metformin |
|
SURPASS-6 [57] |
NCT04537923 | Active, not recruiting | 1182 |
HbA1c 7.5–11%, BMI ≥ 23 and ≤ 45 kg/m2 at screening Stable background medications (insulin glargine (U100) ± metformin) |
eGFR < 30 ml/min/1.73m2 (< 45 if treated with metformin) | Tirzepatide 5, 10, or 15 mg SC once a week vs. insulin lispro (U100) SC three times a day with insulin glargine (U100) SC | Insulin glargine or insulin glargine + metformin |
SC subcutaneous