Recruiting
Phase 1

Eloralintide

Sponsor:

Eli Lilly and Company

Code:

NCT07701083

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Eloralintide

Study Details

Brief summary:

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.

Conditions

Healthy Volunteers

Study ID

NCT07701083

Start date

Jul 20, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Eloralintide (Reference)

Participants will receive eloralintide reference formulation administered subcutaneously (SC).

experimental: Eloralintide (Test)

Participants will receive eloralintide test formulation administered SC.

Interventions

Eloralintide

Administered SC.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

866-429-3700

Principal Investigator:

Hugh Coleman

Fortrea Clinical Research Unit

Recruiting

Dallas, Texas, United States, 75247

Contacts

866-429-3700

Principal Investigator:

Archie Bowie

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-20.