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A Study of LY3841136 in Overweight and Obese Participants

Plain-language guide to NCT06345066: phase 1 randomized trial of Tirzepatide and Eloralintide, 96 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06345066
Phase
phase 1
Status
completed
Start
2024-04-03
Completion (planned or actual)
2025-09-29
Participants
96 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Obesity; Overweight
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1 trial, researchers set out to test Tirzepatide and Eloralintide.

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients.

The study will last up to approximately 42 weeks.

It had two arms (groups): LY3841136 + Tirzepatide (experimental) and Placebo + Tirzepatide (placebo comparator).

LY3841136 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

96 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male and female participants who are overtly healthy as determined by medical evaluation. Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²). Have clinical laboratory test results within normal reference range. Have venous access sufficient to allow for blood sampling. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have type 1 or type 2 diabetes mellitus; have an abnormal 12-lead electrocardiogram (ecg); have a history or presence of psychiatric disorders.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2024-04-03 with completion listed for 2025-09-29.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration (time frame: Baseline up to 42 weeks).

It also tracked 3 secondary outcomes, for example Percent change from baseline in body weight.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide and Eloralintide in 96 people.

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

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

Our Notes on the Compounds

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Eloralintide: An investigational selective amylin-receptor agonist studied in once-weekly phase 2 obesity trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.