Overweight, Obesity
Conditions
Keywords
Healthy
Brief summary
The main purpose of the study is to measure and compare the effects of eloralintide and placebo on insulin sensitivity (how your body responds to insulin), metabolic health (things like sugar and cholesterol), and body weight in participants with obesity or overweight. For each participant, the study will last about 35 weeks and include 3 in patient visits totaling 7 days.
Interventions
DRUGEloralintide
Eloralintide administered SC
OTHERPlacebo
Placebo administered SC
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Have an hemoglobin A1c (HbA1c) value at screening of less than 6.5 percent (%). * Have a body mass index between 25 and 45 Kilogram per Square Meter (kg/m²). * Have had a stable body weight that has changed by less than 5% during the 3 months prior to screening. * Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB). Individuals of childbearing potential (IOCBP) and individuals not of childbearing potential (INOCBP) may participate in this study.
Exclusion criteria
* Have type 1 or type 2 diabetes mellitus, a history of ketoacidosis, or of hyperosmolar state or coma. Note: Participants with a history of gestational diabetes are eligible to participate in this study. * Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis. * Have a known clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal (GI) motility to a significant extent. * Have a prior or planned surgical treatment for obesity. Exceptions: The following are allowed if they occurred more than 1 year before screening: * liposuction * cryolipolysis, or * abdominoplasty. * Are unwilling to comply with the lifestyle and dietary restrictions required for this study. * Are individuals AFAB who are lactating. * Are individuals AFAB who are pregnant or intend to become pregnant or to breastfeed during the study, or individuals AMAB who intend to conceive a pregnancy during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline In Hyperinsulinemic Euglycemic Clamp (HEC) Predicted Clamp-Derived Insulin Sensitivity (M-value) | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline In Body Weight | Baseline, Week 24 |
Countries
Germany, Sweden
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