Obesity, Overweight
Conditions
Keywords
Safety and Tolerability, Chinese, LY3502970
Brief summary
The main purpose of this study is to learn about the safety and tolerability of LY3502970 when given to Chinese participants with obesity or overweight with weight-related comorbidities. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive LY3502970, or placebo given orally. For each participant, the study will last about approximately 22- and 30-weeks for both cohort 1 and 2, respectively including screening period.
Interventions
DRUGLY3502970
Administered orally.
DRUGPlacebo
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Are native Chinese males or females * Have had a stable body weight for the 3 months prior to randomization (less than 5% body weight change) and body mass index of ≥ 30.0 kilograms per square meter (kg/m²) or between 27.0 up to 30.0 kg/m² with at least 1 of the following weight-related comorbidities including Hypertension, Dyslipidemia, Cardiovascular disease, Obstructive sleep apnea
Exclusion criteria
* Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus * Have used or intend to use any prescription or over-the-counter medications or traditional Chinese treatments within 3 months prior to screening, exception of medications for the treatment of concurrent medical conditions with a stable dose * Have known allergies to GLP-1RAs, LY3502970, related compounds, any components of the formulation, or have a history of significant atopy * Are overweight or have obesity induced by other endocrinological disorders, diagnosed monogenetic, or syndromic forms of obesity * Have or plan to have a surgical, endoscopic or device-based treatment for obesity * Have a history or presence of psychiatric disorder, a moderately severe or severe depression status, or a significantly risk for suicide * Have a history of acute or chronic pancreatitis * Have a known self or family history of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma * Have other acute, chronic, or uncontrolled medical conditions, vital organ failure or abnormal laboratory value in the judgment of the investigator would make the participant inappropriate for entry into this study
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 through Week 18 (Cohort 1) & Week 26 (Cohort 2) | A summary of TEAEs, 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 |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 1) | Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose) | Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol. |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2) | Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose) | Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol. |
| PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 1) | Cohort 1: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose) | Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol. |
| PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2) | Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose) | Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol. |
| PD: Change From Baseline in Body Mass Index | Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2) | PD: Change from baseline in Body Mass Index calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Body Mass Index. |
| Pharmacodynamics (PD): Change From Baseline in Body Weight | Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2) | PD: Change from baseline in body weight calculated as post-baseline value minus baseline value. Negative values indicate a decrease in body weight. |
| PD: Change From Baseline in Waist Circumference | Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2) | PD: Change from baseline in Waist Circumference calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Waist Circumference. |
| PD: Change From Baseline in Fasting Plasma Glucose | Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2) | PD: Change From Baseline in Fasting Plasma Glucose calculated as post-baseline value minus baseline value. Negative values indicate a decrease from baseline |
Countries
China
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 | 29.8 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Region of Enrollment China | 4 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 4 |
| other Total, other adverse events | 10 / 10 | 10 / 10 | 3 / 4 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 4 |
Outcome results
None listed