A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide.

The study will last for about 89 weeks.

It had four arms (groups): one (experimental), one (experimental), Tirzepatide (active comparator) and Placebo (placebo comparator).

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive tirzepatide SC.

Participants will receive tirzepatide SC.

The registry classes the interventions as drug.

More on the Plan

The study will include a screening period of up to 5 weeks.

The primary endpoint will be at Week 44 with a tirzepatide extension until week 80.

A safety follow up will be performed approximately 4 weeks after end of treatment.

Who Took Part

The registry lists 414 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening. Have been diagnosed with Type 2 Diabetes (T2D).

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: have type 1 diabetes (t1d), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except t2d; have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening; are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-09-21 with completion listed for 2026-01-08.

It ran at 40 sites in United States (20), Turkey (Türkiye) (9), Mexico (6) and Argentina (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Body Weight (time frame: Baseline (Week 0), Week 44).

It also tracked 12 secondary outcomes, for example Change from Baseline in HbA1c, Change from Baseline in HbA1c, Percent Change from Baseline in Body Weight, Absolute Change from Baseline in Body Weight, Absolute Change from Baseline in Body Weight and Change from Baseline in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 414 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.