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A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

LY3437943

Placebo

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

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

Inclusion Criteria:

For All Participants:

Are native Chinese males or females
Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²)
Have not modified diet or adopted any nutritional lifestyle modification for 3 months
Have stable body weight for the last three months
Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential

For Type 2 Diabetes Mellitus (T2DM) Participants:

Have type 2 diabetes for at least 3 months
Have a glycated hemoglobin (HbA1c) value of ≥7.0% and ≤10.5% and have been treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening

Exclusion Criteria:

For All Participants:

Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week and smoke more than 10 cigarettes, or cigarette equivalent (as determined by investigator), per day
Have other serious or unstable illnesses
Have had an episode of severe hypoglycemia
Current or chronic history of liver disease.

For T2DM Participants:

Have type 1 diabetes mellitus
Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
Any glucose-lowering medications other than metformin within 3 months prior to screening

Sites / Locations

West China Hospital of Sichuan University
Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3437943

Placebo

Arm Description

LY3437943 administered subcutaneously (SC)

Placebo administered SC

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 Concentration (Cmax) of LY3437943

PK: Cmax of LY3437943

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943

PK: AUC of LY3437943

Full Information

NCT ID

NCT05548231

First Posted

September 16, 2022

Last Updated

August 10, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05548231

Brief Title

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Official Title

A Multiple Dose Escalation Study in Chinese Participants With Overweight BMI or Obesity to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

October 24, 2022 (Actual)

Primary Completion Date

July 27, 2023 (Actual)

Study Completion Date

July 27, 2023 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity. 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 injections of LY3437943 or placebo given just under the skin. For each participant, the study will last about 20 weeks excluding screening period and may include up to 20 visits to the study center.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3437943

Arm Type

Experimental

Arm Description

LY3437943 administered subcutaneously (SC)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC

Intervention Type

Drug

Intervention Name(s)

LY3437943

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

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 20

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

Description

PK: Cmax of LY3437943

Time Frame

Predose through Day 109

Title

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943

Description

PK: AUC of LY3437943

Time Frame

Predose through Day 109

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For All Participants: Are native Chinese males or females Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²) Have not modified diet or adopted any nutritional lifestyle modification for 3 months Have stable body weight for the last three months Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential For Type 2 Diabetes Mellitus (T2DM) Participants: Have type 2 diabetes for at least 3 months Have a glycated hemoglobin (HbA1c) value of ≥7.0% and ≤10.5% and have been treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening Exclusion Criteria: For All Participants: Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week and smoke more than 10 cigarettes, or cigarette equivalent (as determined by investigator), per day Have other serious or unstable illnesses Have had an episode of severe hypoglycemia Current or chronic history of liver disease. For T2DM Participants: Have type 1 diabetes mellitus Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization Any glucose-lowering medications other than metformin within 3 months prior to screening

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

West China Hospital of Sichuan University

City

Cheng Du

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Peking University First Hospital

City

Beijing

ZIP/Postal Code

100034

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

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