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

A Phase 1, Open-Label, Single and Multiple Dose Study to Investigate the Safety, Tolerability, and Relative Bioavailability of Single and Multiple Weekly Subcutaneous Doses of Eloralintide, and Single and Multiple Weekly Subcutaneous Doses of Eloralintide With Tirzepatide in Participants With Overweight or Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Eloralintide and Tirzepatide; Drug: Eloralintide

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eloralintide and Tirzepatide-Cohorts A-D; Eloralintide and Tirzepatide administered subcutaneously (SC)	Drug: Eloralintide and Tirzepatide; Administered SC; Other Names: LY3841136
Experimental: Eloralintide-Cohorts E and F; Eloralintide administered SC	Drug: Eloralintide; Administered SC; Other Names: LY3841136

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Actual): January 19, 2026
• Study Completion (Actual): January 19, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: 27353; J3R-MC-YDAE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No