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

Phase 1

Not yet recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: Eloralintide and Tirzepatide; Drug: Eloralintide

• Registration Number: NCT06916065
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it.

There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eloralintide and Tirzepatide-Cohorts A-D	Eloralintide and Tirzepatide	Eloralintide and Tirzepatide administered subcutaneously (SC)
Eloralintide-Cohorts E and F	Eloralintide	Eloralintide administered SC

Primary Outcome Measures

Name	Time	Method
Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide	Day 106 Predose to Approximately Week 26	PK: AUC of Eloralintide and Tirzepatide
Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide	Day 106 Predose to Approximately Week 26	PK: Cmax of Eloralintide and Tirzepatide
Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide	Baseline Up to Approximately Week 11	PK: AUC of Eloralintide and Tirzepatide
Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide	Baseline Up to Approximately Week 11	PK: Cmax of Eloralintide and Tirzepatide
Cohorts E and F: PK: AUC of Eloralintide	Day 8 Predose Up to Approximately Week 12	PK: AUC of Eloralintide
Cohorts E and F: PK: Cmax of Eloralintide	Day 8 Predose Up to Approximately Week 12	PK: Cmax of Eloralintide
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	Baseline Up to Approximately Week 26	A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Trial Locations

Locations (2)

Fortrea Clinical Research Unit; 🇺🇸 Dallas, Texas, United States

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States