Healthy, Obese
Conditions
Keywords
Pharmacokinetics, Safety and Tolerability, LY3502970
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.
Interventions
DRUGLY3502970
Administered orally.
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants with stable body weight for at least one month prior to randomization. * Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²) * Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
Exclusion criteria
* Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs * Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders * Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %
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 up to Day 42 | A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, 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 participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (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, 6, 8, 12, 16 and 24 hours post-dose) | PK: AUC\[0-tlast\] of LY3502970 |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1 | Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) | PK: Cmax of LY3502970 |
| PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1 | Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) | PK: Tmax of LY3502970 |
| PK: AUC[0-tlast] of LY3502970 on Day 28 | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) | PK: AUC\[0-tlast\] of LY3502970 |
| PK: Cmax of LY3502970 on Day 28 | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) | PK: Cmax of LY3502970 |
| PK: Tmax of LY3502970 on Day 28 | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) | PK: Tmax of LY3502970 |
| Pharmacodynamics (PD): Change From Baseline in Body Weight | Baseline through Day 29 | PD: Change From Baseline in Body Weight |
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, Continuous | 42.3 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 24 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 19 / 24 | 20 / 24 | 13 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
None listed