A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

NCT03861039 · Completed

Last updated 2026-05-28

This study is testing the long-term safety of the medication tirzepatide in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 443 people

Who can join Ages 20+ · all sexes

Timeline Started 2019-03 · est. completion 2021-02

Where 34 sites · Japan

What this study is testing ClinicalTrials.gov NCT03861039 ↗

Description as written by the study sponsor.

The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.

Treatments tested

Tirzepatide also known as LY3298176 Drug

Administered SC
Oral antihyperglycemic medication (OAM) Drug

Oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Main thing measured	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Sponsor	Eli Lilly and Company
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03861039 ↗