A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity

Launched by ELI LILLY AND COMPANY · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called eloralintide, both on its own and in combination with another drug called tirzepatide, to see how well they are tolerated by people who are overweight or obese. The trial aims to find out if participants experience any side effects and how the body processes these medications. Over the course of the study, which lasts up to 26 weeks, participants will receive the study drugs through a simple injection under the skin and will have blood tests done to monitor how much of the medication enters their bloodstream.

To be eligible for this trial, participants need to be aged between 18 and 75 years and have a body mass index (BMI) between 27 and 40. They should also have maintained a stable weight for at least three months before the study. However, people with certain health conditions, such as diabetes, significant heart problems, or a history of certain cancers, will not be able to participate. This study is not yet recruiting participants, but it is an important step in understanding new treatments for overweight and obesity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Participants with a history of thyroid disease or on thyroid medication will need to be biochemically euthyroid as assessed by measuring thyroid stimulating hormone at screening
• • Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive
• • Have had a stable weight for the 3 months prior to screening and enrollment, that is, less than 5% body weight change
• Exclusion Criteria:
• • Have known allergies to related compounds of eloralintide or tirzepatide, or any of the components of the formulations
• • Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
• • Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol/mol)
• • Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• • Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis
• • Have obesity induced by other endocrinologic disorders for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity for example, Melanocortin 4 Receptor deficiency or Prader Willi syndrome
• • Have a history of hypocalcemia or hypercalcemia, or abnormal laboratory values for calcium or serum phosphorus
• * Have a medical history or current evidence of clinically significant cardiac condition, as per the investigator, including:
• • second or third degree heart block
• • sick sinus syndrome
• • peripheral arterial circulatory disorders
• • valvular disease
• • cardiomyopathy, or
• • other clinically significant cardiac condition
• • Have taken approved or investigational medication for weight loss, including GLP-1 RAs, within the previous 3 months of study screening
• • Intend to use any weight loss medications during study participation