A Study of Eloralintide (LY3841136) in Healthy Participants

Purpose

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.

Condition

  • Healthy Volunteers

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Fortrea Clinical Research Unit
Daytona Beach, Florida 32117
Contact:
866-429-3700

Fortrea Clinical Research Unit
Dallas, Texas 75247
Contact:
866-429-3700

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com