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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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.
What This Study Doesn't 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.
Trust & Context
- Original Title:
- 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.
- Published In:
- Lancet (London, England), 398(10295), 143-155 (2021)
- Authors:
- Rosenstock, Julio(10), Wysham, Carol, Frías, Juan P(2), Kaneko, Shizuka, Lee, Clare J, Fernández Landó, Laura, Mao, Huzhang, Cui, Xuewei, Karanikas, Chrisanthi A, Thieu, Vivian T
- Database ID:
- RPEP-05727
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-05727APA
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
MLA
Rosenstock, Julio, et al. "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, 2021. https://doi.org/10.1016/S0140-6736(21)01324-6
RethinkPeptides
RethinkPeptides Research Database. "Efficacy and safety of a novel dual GIP and GLP-1 receptor a..." RPEP-05727. Retrieved from https://rethinkpeptides.com/research/rosenstock-2021-efficacy-and-safety-of
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.