Healthy
Conditions
Brief summary
The main purpose of this study is to assess how well LY4226695 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant in Parts A & D, the study will last about 64 days and will include a stay in the Clinical Research Unit (CRU) lasting at most 7 days. For each participant in Parts B & C, the study will last about 92 days and will include 5 stays in the CRU with each visit lasting at most 7 days.
Interventions
DRUGLY4226695
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
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a screening body mass index (BMI) in the range of 18.5 to 35 kilograms per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening. * Individuals assigned male at birth must agree to adhere to contraception restrictions and individuals assigned female at birth must not be of childbearing potential. * Part B Chinese participants: * To qualify as a Chinese participant for the purpose of this study, all the participants' biological grandparents must be Chinese and born in China. * Part C Japanese participants: * To qualify as a Japanese participant for the purpose of this study, all the participants' biological grandparents must be Japanese and born in Japan.
Exclusion criteria
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders. * Have known or ongoing psychiatric disorders. * Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children). * Have a history of fracture within 6 months prior to screening. * Have a history of fainting. * Regularly use known drugs of abuse or with positive drug results. * Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 57 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4226695 | Baseline through Day 57 |
| PK: Maximum Concentration (Cmax) of LY4226695 | Baseline through Day 57 |
Countries
Singapore, United States
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