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Purpose

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

Eligibility

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

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eloralintide Cohort 1 		Eloralintide administered subcutaneously (SC)
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
  • Drug: Acetaminophen
    Administered Oral Solution
Experimental
Eloralintide Cohort 2 		Eloralintide administered SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
  • Drug: Acetaminophen
    Administered Oral Solution
Experimental
Eloralintide Cohort 3 		Eloralintide administered SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
  • Drug: Acetaminophen
    Administered Oral Solution
Experimental
Eloralintide Cohort 4 		Eloralintide administered SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
  • Drug: Acetaminophen
    Administered Oral Solution
Placebo Comparator
Placebo 		Placebo administered SC
  • Drug: Placebo
    Administered SC
  • Drug: Acetaminophen
    Administered Oral Solution

Recruiting Locations

ICON Early Phase Services
San Antonio, Texas 78209
Contact:
210-225-5437

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.