A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

NCT ID: NCT05548231

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2023-07-27

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3437943

LY3437943 administered subcutaneously (SC)

Group Type: EXPERIMENTAL

LY3437943

Intervention Type: DRUG

Administered SC

Placebo

Placebo administered SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

Interventions

LY3437943

Administered SC

Intervention Type: DRUG

Placebo

Administered SC

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Peking University First Hospital

Beijing, , China

Countries

China

Other Identifiers

J1I-MC-GZBE

Identifier Type: OTHER

Identifier Source: secondary_id

17954

Identifier Type: -

Identifier Source: org_study_id