Healthy, Obese
Conditions
Brief summary
The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.
Interventions
DRUGLY3502970
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Part A open label. Part B double blinded (Investigator and Participant blinded).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants who are overtly healthy as determined by medical evaluation * Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more * Participants with a stable body weight, with 5% or less body weight gain or loss
Exclusion criteria
* Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL) * Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome * Have known clinically significant gastric emptying abnormality * Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass) * Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer * Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug * Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13 | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13 | PK: AUC\[0-24\] of LY3502970 in fasted state |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13 | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13 | PK: Cmax of LY3502970 in fasted state |
| PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13 | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13 | PK: Tmax of LY3502970 in fasted state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10 | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70) | PK: AUC\[0-24\] of LY3502970 in fed state |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10 | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70) | PK: Cmax of LY3502970 in fed state |
| PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10 | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70) | PK: Tmax of LY3502970 in fed state |
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
Participant flow
Recruitment details
The study had two sequential parts ; Part A and Part B. Part A consisted of dosing periods 1 to 11 and Part B consisted of dosing periods 12 and 13. Participants enrolled in the study, began in Part A, and continued into Part B.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 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 | 27 Participants |
| Region of Enrollment United States | 52 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 29 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 49 | 0 / 49 | 0 / 46 | 0 / 46 | 0 / 45 | 0 / 21 | 0 / 21 | 0 / 41 | 0 / 7 | 0 / 7 | 0 / 21 | 0 / 21 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 7 / 52 | 6 / 50 | 3 / 50 | 8 / 50 | 13 / 49 | 9 / 49 | 4 / 46 | 4 / 46 | 2 / 45 | 3 / 21 | 12 / 21 | 12 / 41 | 3 / 7 | 1 / 7 | 4 / 21 | 5 / 21 | 3 / 12 | 6 / 12 |
| serious Total, serious adverse events | 0 / 52 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 49 | 0 / 49 | 0 / 46 | 1 / 46 | 1 / 45 | 0 / 21 | 0 / 21 | 0 / 41 | 0 / 7 | 0 / 7 | 0 / 21 | 0 / 21 | 0 / 12 | 0 / 12 |
Outcome results
None listed