Healthy
Conditions
Brief summary
The main purposes of this study are to determine: * The safety of LY3502970 and any side effects that might be associated with it. * How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it. This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.
Interventions
DRUGLY3502970
Administered orally.
DRUGPlacebo
Administered orally.
DRUGAtorvastatin
Administered orally.
DRUGSimvastatin
Administered orally.
DRUGMidazolam
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Part C is a crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or females, as determined by medical history * Have safety laboratory results within normal reference ranges
Exclusion criteria
* Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds * Abnormal electrocardiogram (ECG) at screening * Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline through Follow-up (up to Day 42) | An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall 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 |
|---|---|---|
| Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose | PK: Cmax of LY3502970 |
| Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 | Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose | PK: AUC(0-tlast) of LY3502970 |
| Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 | Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose | PK: Tmax of LY3502970 |
| Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose) | PK: Cmax of LY3502970 |
| Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 28 | Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose) | PK: Cmax of LY3502970 |
| Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose) | PK: AUC(0-tlast) of LY3502970 |
| Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 28 | Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose) | PK: AUC(0-tlast) of LY3502970 |
| Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 1 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose) | PK: Tmax of LY3502970 |
| Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 28 | Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose) | PK: Tmax of LY3502970 |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 133 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 15 | 0 / 45 | 0 / 18 | 0 / 17 | 0 / 8 | 0 / 9 | 0 / 17 | 0 / 8 | 0 / 17 | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 2 | 0 / 21 | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 1 / 8 | 1 / 6 | 1 / 6 | 3 / 6 | 5 / 6 | 4 / 15 | 16 / 45 | 8 / 18 | 6 / 17 | 5 / 8 | 6 / 9 | 8 / 17 | 2 / 8 | 9 / 17 | 2 / 12 | 0 / 12 | 2 / 6 | 0 / 2 | 4 / 21 | 4 / 20 | 6 / 19 | 5 / 19 | 0 / 9 | 1 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 15 | 0 / 45 | 0 / 18 | 0 / 17 | 0 / 8 | 0 / 9 | 0 / 17 | 0 / 8 | 0 / 17 | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 2 | 0 / 21 | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 9 | 0 / 10 |
Outcome results
None listed