Obesity, Overweight
Conditions
Brief summary
The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.
Interventions
DRUGBrenipatide
Administered SC.
OTHERPlacebo
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease, as determined by medical evaluation * Have a BMI within the range of 27.0 to 45.0 kilogram per square meter (kg/m\^2) * Have no significant (not more than 5 percent \[%\]) self-reported weight gain or loss in the past 3 months prior to screening
Exclusion criteria
* Have significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination; constituting a risk when taking the Investigational Medical Product (IMP); or interfering with the interpretation of data * Have a prior diagnosis of type 1 or type 2 diabetes mellitus * Have a history of acute or chronic pancreatitis * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 * Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, GIP/GLP-1/glucagon receptor agonist, or amylin receptor agonist within 6 months prior to screening * Have been treated with prescription and over-the-counter medications, or alternative remedies (including herbal/nutritional supplements), that promote weight loss within 6 months prior to screening * Are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Body Weight | Week 1, Week 29 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants who discontinued due to an Adverse Events (AEs) | Day 1 through Week 37 |
| Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs | Day 1 through Week 37 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide | Pre-dose on Day 1 through Week 37 |
| PK: Maximum Concentration (Cmax) of Brenipatide | Pre-dose on Day 1 through Week 37 |
| Percentage of Participants Achieving ≥ 5% Reduction in Body Weight | Week 29 |
| Change in Waist Circumference | Week 1, Week 29 |
| Change in Waist-to-Height Ratio | Week 1, Week 29 |
| Change in Blood Pressure | Week 1, Week 29 |
| Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C) | Week 1, Week 29 |
| Change in High-sensitive C-reactive Protein (hsCRP) | Week 1, Week 29 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
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