A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight
Recruiting · NCT07738614 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 1 US state.
- ICON Early Phase Services - San Antonio, Texas, United States
- Lilly Centre for Clinical Pharmacology - Singapore, Singapore