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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brenipatide 		Participants will receive brenipatide subcutaneously (SC).
  • Drug: Brenipatide
    Administered SC.
    Other names:
    • LY3537031
Placebo Comparator
Placebo 		Participants will receive placebo administered SC.
  • Other: Placebo
    Administered SC.

Recruiting Locations

Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida 32117-5116
Contact:
866-429-3700

Fortrea Clinical Research Unit
Dallas, Texas 75247
Contact:
866-429-3700

Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin 53704
Contact:
866-429-3700

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.