A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
- Registration Number
- NCT06023095
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3502970 LY3502970 LY3502970 administered orally Placebo Placebo Placebo administered orally
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose PK: Cmax of LY3502970
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 hour Time Point (AUC0-24) of LY3502970 Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose PK: AUC0-24 of LY3502970
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
Trial Locations
- Locations (3)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Shanghai General Hospital
🇨🇳Shanghai, Songjiang, China