Study S000407

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03954834
Acronym: SURPASS-1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 478
Start: 2019-06-03
Primary completion: 2020-10-05
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPGK

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 40]

Linked records (6)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0010804	Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. De Block C, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Randomized trial	PMID 39531161 DOI	cites ClinicalTrials.gov:NCT03954834; registry reference DERIVED:39531161
R0007531	Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Boye KS, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 37526908 DOI	cites ClinicalTrials.gov:NCT03954834; registry reference DERIVED:37526908
R0009342	Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Boye KS, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 37668888 DOI	cites ClinicalTrials.gov:NCT03954834; registry reference DERIVED:37668888
R0012252	Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Sattar N, Nature medicine	2022	Systematic review	PMID 35210595 DOI	cites ClinicalTrials.gov:NCT03954834; registry reference DERIVED:35210595
R0023137	Tirzepatide-Friend or Foe in Diabetic Cancer Patients? Samuel SM, Biomolecules	2022	Other trial	PMID 36358930 DOI	cites ClinicalTrials.gov:NCT03954834
R0016044	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. Rosenstock J, Lancet (London, England)	2021	Randomized trial	PMID 34186022 DOI	cites ClinicalTrials.gov:NCT03954834; registry reference DERIVED:34186022