A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities

Obesity Clinical Trial

Official title:

A Multiple Dose Titration Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Chinese Participants Who Have Obesity or Are Overweight With Weight-related Comorbidities

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
• 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
• 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

Related Conditions & MeSH terms

• Obesity
• Overweight

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)