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Table 4 Key information of the SURPASS 1–6 clinical trials with the glucose-lowering dual GIP/GLP-1 receptor agonist tirzepatide

From: Report from the CVOT Summit 2021: new cardiovascular, renal, and glycemic outcomes

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
  1. SC subcutaneous