Obesity, Overweight
Conditions
Keywords
Healthy
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.
Interventions
DRUGEloralintide
Administered SC
DRUGPlacebo
Administered SC
DRUGAcetaminophen
Administered Oral Solution
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acetaminophen Area Under the Concentration Versus Time Curve (AUC) | Baseline to Day 65 |
| Acetaminophen Maximum Observed Concentration (Cₘₐₓ) | Baseline to Day 65 |
| Acetaminophen Time to Maximum Observed Drug Concentration (tₘₐₓ) | Baseline to Day 65 |
Secondary
| Measure | Time frame |
|---|---|
| Eloralintide AUC | Baseline to Day 106 |
| Eloralintide Cₘₐₓ | Baseline to Day 106 |
Countries
Singapore, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed