A Study of LY3457263 in Obese Participants

What Was Tested

The trial (phase 1) is built around Tirzepatide.

The main purpose of this study is to evaluate the safety and tolerability of LY3457263 when administered in combination with tirzepatitide in overweight or obese participants.

The study will also evaluate how much of LY3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants.

The study will last up to approximately 11 weeks.

It had two arms (groups): LY3457263 + Tirzepatide (experimental) and Placebo + Tirzepatide (placebo comparator).

LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.

Placebo administered SC in combination with tirzepatide given SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 20 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participants who are overtly healthy as determined by medical evaluation. Have a stable body weight and body mass index (BMI) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²). Male or female participants not of childbearing potential.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: have an abnormal 12-lead electrocardiogram (ecg) at screening; have type 1 or type 2 diabetes mellitus.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2022-11-11 with completion listed for 2023-06-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to 11 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 38 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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