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Research citation

Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.

Randomized Controlled TrialStrong evidence

This record provides bibliographic details and links to the original research. An editorial study breakdown is not available.

What the researchers found

Tirzepatide (5, 10, 15 mg weekly) reduced HbA1c by 1.87-2.07% and body weight by 7.0-9.5 kg over 40 weeks vs placebo, with no severe hypoglycemia in 478 patients with type 2 diabetes.

Why it matters

Tirzepatide combines two incretin pathways in one drug, achieving better blood sugar and weight outcomes than most single-pathway drugs. This trial helped establish it as a major new option for type 2 diabetes.

The numbers in context

478 patients; 52 sites in 4 countries; HbA1c: -1.87 to -2.07% vs +0.04% placebo; weight: -7.0 to -9.5 kg; nausea 12-18%; no severe hypoglycemia; 40 weeks

How the study worked

Double-blind, randomized, placebo-controlled phase 3 trial (SURPASS-1) at 52 centers in 4 countries. 478 adults with type 2 diabetes randomized 1:1:1:1 to tirzepatide 5, 10, or 15 mg weekly or placebo for 40 weeks.

Who was studied

Adults with type 2 diabetes inadequately controlled by diet and exercise, naive to injectable therapy, mean age 54, BMI 31.9

What this study cannot tell us

40-week duration may not capture long-term safety. Participants were treatment-naive (no prior injectable therapy), so results may differ in previously treated patients. Funded by Eli Lilly. Gastrointestinal side effects affected a notable proportion of patients.

Read the original research

Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.

Lancet (London, England), 398(10295), 143-155

Citation

Rosenstock, Julio; Wysham, Carol; Frías, Juan P; Kaneko, Shizuka; Lee, Clare J; Fernández Landó, Laura; Mao, Huzhang; Cui, Xuewei; Karanikas, Chrisanthi A; Thieu, Vivian T. (2021). Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.. Lancet (London, England), 398(10295), 143-155. https://doi.org/10.1016/S0140-6736(21)01324-6