A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548231
• Other study ID #: 17954
• Secondary ID: J1I-MC-GZBE
• Status: Completed
• Phase: Phase 1
• Start date: October 24, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: August 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• LY3437943
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing
China	West China Hospital of Sichuan University	Cheng Du	Sichuan

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 20
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943	PK: Cmax of LY3437943	Predose through Day 109
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943	PK: AUC of LY3437943	Predose through Day 109