Study S000239

A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record Study Protocol: Clinical Study Protocol Amendment Version (a) (PDF)Study Protocol: Clinical Study Protocol Addendum Version (1) (PDF)Statistical Analysis Plan: Statistical Analysis Plan Version 2 (PDF)Statistical Analysis Plan: Statistical Analysis Plan Addendum Version 2 (PDF)

Registration

Registration: NCT03861052
Acronym: SURPASS J-mono
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 636
Start: 2019-05-07
Primary completion: 2021-03-10
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Tirzepatide; DRUG:Dulaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-JE-GPGO

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 52]

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
R0011492	Insulin Sensitivity and Beta-Cell Function Following Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J-mono Analysis. Hamamoto Y, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Randomized trial	PMID 39951042 DOI	cites ClinicalTrials.gov:NCT03861052; registry reference DERIVED:39951042
R0015987	Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Mimura H, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Other	PMID 40711720 DOI	cites ClinicalTrials.gov:NCT03861052; registry reference DERIVED:40711720
R0013761	Metabolic Abnormalities Following Tirzepatide Monotherapy in Japanese Patients with Type 2 Diabetes: A Phase 3 SURPASS J-mono Post Hoc Analysis. Onishi Y, Diabetes therapy : research, treatment and education of diabetes and related disorders	2024	Randomized trial	PMID 38310163 DOI	cites ClinicalTrials.gov:NCT03861052; registry reference DERIVED:38310163
R0013931	Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type 2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial. Ishii H, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 37843771 DOI	cites ClinicalTrials.gov:NCT03861052; registry reference DERIVED:37843771
R0012252	Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Sattar N, Nature medicine	2022	Systematic review	PMID 35210595 DOI	cites ClinicalTrials.gov:NCT03861052; registry reference DERIVED:35210595
R0012580	Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Inagaki N, The lancet. Diabetes & endocrinology	2022	Randomized trial	PMID 35914543 DOI	cites ClinicalTrials.gov:NCT03861052; registry reference DERIVED:35914543