Healthy
Conditions
Brief summary
The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Interventions
DRUGLY3985863
Administered SC
DRUGPlacebo
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 native Chinese participants * Are overtly healthy * Have body weight of at least 50.0 kilogram (kg) for male or 45.0 kg for female and a body mass index of 20.0 to 30.0 kilogram per square meter (kg/m²), inclusive * Have a stable body weight within 3 months
Exclusion criteria
* Have known allergies to any components of the LY3985863 formulation * Have concomitant disease known to influence skeletal muscle protein * Have current or a history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication or completing study procedures, or of interfering with the interpretation of the data * Have a 12-lead echocardiogram (ECG) abnormality * Have used within 3 months or intend to use medications during the study that promote weight loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline to Study Completion (Up to 19 Weeks) | A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863 | Predose on Day 1 up to Approximately Week 8 Post Dose | PK: Cmax of LY3985863 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863 | Predose on Day 1 up to Approximately Week 8 Post Dose | PK: AUC of LY3985863 |
Countries
China
Contacts
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