A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Drug: LY3437943
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3437943<br>LY3437943 administered subcutaneously (SC) | Drug: LY3437943<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Placebo administered SC | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943 | PK: Cmax of LY3437943 | Predose through Day 109 | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943 | PK: AUC of LY3437943 | Predose through Day 109 |