A Study of LY3437943 in Healthy Participants With a High Body Mass Index

Healthy Clinical Trial

Official title:

Effect of Injection Site on the Relative Bioavailability of a Single Dose of LY3437943 in Healthy Participants With a High Body Mass Index

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05959096
• Other study ID #: 18532
• Secondary ID: J1I-MC-GZBS
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 18, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A. In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 157 days and 99 days for Part A and Part B, respectively.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
• Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive
• Are agreeable to receiving study treatment by injections under the skin or through a vein.

Exclusion Criteria:

• Have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form)
• Have a significant history of, or presence of, any of the following disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Have known allergies to LY3437943, related compounds, or any components of the formulation
• Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day.
• Is a known user of drugs of abuse

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3437943
Administered SC
• LY3437943
Administered IV

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3437943	Part A: PK: AUC(0-8) of LY3437943	Predose on Day 1 up to 43 days postdose (Part A)
Primary	Part A: PK: Maximum Concentration (Cmax) of LY3437943	Part A: PK: Cmax of LY3437943	Predose on Day 1 up to 43 days postdose (Part A)
Secondary	Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3437943	Part B: PK: AUC(0-8) of LY3437943	Predose on Day 1 up to 71 days postdose (Part B)
Secondary	Part B: PK: Maximum Concentration (Cmax) of LY3437943	Part B: PK: Cmax of LY3437943	Predose on Day 1 up to 71 days postdose (Part B)