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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06023095
Other study ID # 18610
Secondary ID J2A-GH-GZGX
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 21, 2023
Est. completion date July 2024

Study information

Verified date March 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 24
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3502970
Administered orally.
Placebo
Administered orally.

Locations

Country Name City State
China West China Hospital Sichuan University Chengdu Sichuan
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Shanghai General Hospital Shanghai Songjiang

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)
Secondary Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 PK: Cmax of LY3502970 Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose
Secondary PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 hour Time Point (AUC0-24) of LY3502970 PK: AUC0-24 of LY3502970 Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose
Secondary Pharmacodynamics (PD): Change From Baseline in Body Weight PD: Change From Baseline in Body Weight Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
Secondary PD: Change From Baseline in Body Mass Index PD: Change From Baseline in Body Mass Index Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
Secondary PD: Change From Baseline in Waist Circumference PD: Change From Baseline in Waist Circumference Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
Secondary PD: Change From Baseline in Fasting Plasma Glucose PD: Change From Baseline in Fasting Plasma Glucose Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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