A Study of Eloralintide (LY3841136) in Healthy Participants

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Two Eloralintide Solutions in Healthy Participants

The main purpose of this study is to learn about safety, tolerability and how well the body processes two different eloralintide solutions. Participation in this study will last about 13 weeks, including screening, inpatient treatment, and follow-up.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Eloralintide

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit
      • Principal Investigator: Hugh Coleman
      • Contact: Phone Number: 866-429-3700
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit
      • Principal Investigator: Archie Bowie
      • Contact: Phone Number: 866-429-3700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Are overtly healthy as determined by medical evaluation
• Have a body mass index (BMI) within the range of 20.0 to 32.0 kilogram per square meter (kg/m2), inclusive

Exclusion Criteria:

• Have known allergies to related compounds of eloralintide, 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 taken approved or investigational medication for weight loss, including glucagon-like peptide-1 receptor agonists (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: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eloralintide (Reference); Participants will receive eloralintide reference formulation administered subcutaneously (SC).	Drug: Eloralintide; Administered SC.; Other Names: LY3841136
Experimental: Eloralintide (Test); Participants will receive eloralintide test formulation administered SC.	Drug: Eloralintide; Administered SC.; Other Names: LY3841136

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide	Predose on Day 1 through Day 57
PK: Maximum Concentration (Cmax) of Eloralintide	Predose on Day 1 through Day 57

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 27885; J3R-MC-YDAT (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