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

Primary Purpose

Overweight, Obesity

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LY3502970
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Safety and Tolerability, Chinese, LY3502970

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong Provincial People's Hospital
  • West China Hospital Sichuan UniversityRecruiting
  • Shanghai General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3502970

Placebo

Arm Description

LY3502970 administered orally

Placebo administered orally

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970
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
Pharmacodynamics (PD): Change From Baseline in Body Weight
PD: Change From Baseline in Body Weight
PD: Change From Baseline in Body Mass Index
PD: Change From Baseline in Body Mass Index
PD: Change From Baseline in Waist Circumference
PD: Change From Baseline in Waist Circumference
PD: Change From Baseline in Fasting Plasma Glucose
PD: Change From Baseline in Fasting Plasma Glucose

Full Information

First Posted
August 29, 2023
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT06023095
Brief Title
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
November 29, 2024 (Anticipated)
Study Completion Date
November 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Safety and Tolerability, Chinese, LY3502970

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilong Zhong
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yerong YU
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Songjiang
ZIP/Postal Code
201620
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueying Ding

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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