Study S000249

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05260021
Acronym: SURPASS-PEDS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 99
Start: 2022-04-13
Primary completion: 2024-07-30
Lead sponsor: Eli Lilly and Company
Conditions: Type2 Diabetes; Diabetes Mellitus; Diabetes Mellitus, Type 2; T2D; T2DM (Type 2 Diabetes Mellitus); Glucose Metabolism Disorders; Endocrine System Diseases; Metabolic Disease
Interventions: DRUG:Tirzepatide Dose 1; DRUG:Tirzepatide Dose 2; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPGV; EUDRACT_NUMBER:2021-003612-31

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) [Baseline, Week 30]

Linked records (2)

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
R0038504	1134-OR: Reduction in Glomerular Hyperfiltration with Tirzepatide in Youth-Onset T2D PETTER BJORNSTAD, Diabetes	2026	Other trial	DOI	cites ClinicalTrials.gov:NCT05260021
R0011665	Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Hannon TS, Lancet (London, England)	2025	Randomized trial	PMID 40975112 DOI	cites ClinicalTrials.gov:NCT05260021; registry reference DERIVED:40975112