A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

Phase 1 Completed 42 enrolled Eli Lilly and Company

RandomizedCrossoverDouble-blindBasic science

Summary

The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). The study is open to participants with type 2 diabetes. It will last about 42 weeks for each participant.

Timeline

Start: 2020-02-24
Primary completion: 2022-01-25
Completion: 2022-01-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Tirzepatide 15 mg; p = 0.7556; Least Square (LS) Mean Difference -0.49 (95% CI -3.64 to 2.67); Mixed Models Analysis NCT04050553 ↗

Publications

Pieber TR, Svehlikova E, Urva S, Haupt A, Zhou C, Coskun T, Holler V, Fluhr G, Karanikas CA, Milicevic Z, Pratt EJ. Counterregulatory response to hypoglycemia during a hypoglycemic clamp in people with type 2 diabetes treated with tirzepatide. Front Endocrinol (Lausanne). 2025 Sep 2;16:1627947. doi: 10.3389/fendo.2025.1627947. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tirzepatide	Peptide	15 mg	Subcutaneous