A Phase 1, Investigator- and Participant-Blinded, Placebo-Controlled, Randomized, Multiple-Dose Study to Evaluate the Gastric Emptying Delay, Pharmacokinetics, Safety, and Tolerability of Eloralintide in Participants With Obesity or Overweight
Eli Lilly and Company
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- 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 A1…
Interventions
- DrugEloralintide
Administered SC
- DrugPlacebo
Administered SC
- DrugAcetaminophen
Administered Oral Solution
Locations (2)
- ICON Early Phase ServicesSan Antonio, Texas
- Lilly Centre for Clinical PharmacologySingapore