Healthy
Conditions
Brief summary
The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.
Interventions
DRUGLY3192767
Administered SC.
DRUGBasal Insulin Peglispro
Administered SC.
DRUGInsulin Glargine
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
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of \>18.5 and \<30.0 kilogram per square meter (kg/m²), inclusive
Exclusion criteria
* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed * Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug * Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin * Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Study Completion (up to about Day 49) | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Maximum Serum Concentration (Cmax) of LY3192767 | Predose through 336 Hours | PK: Cmax of LY3192767 |
| PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767 | Predose through 336 Hours | PK: AUC(0-inf) of LY3192767 |
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767 | Predose through 36 Hours During Clamp Procedure | PD: Total Amount of Glucose Infused (Gtot) of LY3192767 |
| PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767 | Predose through 36 Hours During Clamp Procedure | PD: Rmax of LY3192767 |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767 | Predose through 336 Hours | PK: Tmax of LY3192767 |
| PD: Change from Baseline in Free Fatty Acids | Predose through 48 Hours Postdose | PD: Change from Baseline in Free Fatty Acids |
| PD: Change from Baseline in Glycerol | Predose through 48 Hours Postdose | PD: Change from Baseline in Glycerol |
| PD: Change from Baseline in Triglycerides | Predose through 48 Hours Postdose | PD: Change from Baseline in Triglycerides |
| PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767 | Predose through 36 Hours During Clamp Procedure | PD: TRmax of LY3192767 |
Countries
Germany
Outcome results
None listed