NCT07701083

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
2mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jul 2026Oct 2026

Study Start

First participant enrolled

July 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Eloralintide (Reference)

ACTIVE COMPARATOR

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

Drug: Eloralintide

Eloralintide (Test)

EXPERIMENTAL

Participants will receive eloralintide test formulation administered SC.

Drug: Eloralintide

Interventions

EloralintideDRUG

Administered SC.

Also known as: LY3841136
Eloralintide (Reference)Eloralintide (Test)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Study Officials

  • 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 DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)