Recruiting
Phase 1

Eloralintide

Sponsor:

Eli Lilly and Company

Code:

NCT07738614

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Eloralintide

Placebo

Acetaminophen

Study Details

Brief summary:

The main purpose of this study is to find out how significantly Eloralintide slows stomach emptying in participants who are overweight or obese. For each participant, the study will last approximately 21 weeks and will include 2 overnight stays in the clinical research unit (CRU) lasting between 4 and 8 days. There will be 13 other visits.

Conditions

Obesity

Overweight

Study ID

NCT07738614

Start date

Jul 31, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Have overweight or obesity, but are otherwise overtly healthy.
  • Have a body mass index (BMI) within the range of 27.0 to 45.0 kilograms (kg)/square meter (m²), inclusive.
  • Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening.

Exclusion Criteria:

  • Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have either of the following at screening

  • A fasting plasma glucose concentration greater than or equal to 126 milligrams (mg)/deciliter (dL) or 7.0 millimoles (mmol)/liter (L), or
  • Hemoglobin A1C (HbA1c) greater than or equal to 6.5% or 48 mmol/mole (mol).
  • Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, and bipolar disorder, within the last 2 years.
  • Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, or GIP/GLP-1/glucagon receptor agonist within 60 days or 5 half-lives, whichever is longer, prior to screening.
  • Are in the judgment of the investigator, actively suicidal or deemed to be at significant risk for suicide.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eloralintide Cohort 1

Eloralintide administered subcutaneously (SC)

experimental: Eloralintide Cohort 2

Eloralintide administered SC

experimental: Eloralintide Cohort 3

Eloralintide administered SC

experimental: Eloralintide Cohort 4

Eloralintide administered SC

placebo comparator: Placebo

Placebo administered SC

Interventions

Eloralintide

Administered SC

Placebo

Administered SC

Acetaminophen

Administered Oral Solution

Primary outcome measure

  • Acetaminophen Area Under the Concentration Versus Time Curve (AUC) [ Time Frame: Baseline to Day 65 ]
  • Acetaminophen Maximum Observed Concentration (Cₘₐₓ) [ Time Frame: Baseline to Day 65 ]
  • Acetaminophen Time to Maximum Observed Drug Concentration (tₘₐₓ) [ Time Frame: Baseline to Day 65 ]

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

ICON Early Phase Services

Recruiting

San Antonio, Texas, United States, 78209

Contacts

210-225-5437

Principal Investigator:

Chinonye Ogbonnaya-Odor

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Healthy

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.