A Study of LY3841136 in Healthy and Overweight Participants

Healthy Clinical Trial

Official title:

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295940
• Other study ID #: 18309
• Secondary ID: J3R-MC-YDAA
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2022
• Est. completion date: January 25, 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 main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

• Have had a stable weight for the last 3 months

• Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)

Exclusion Criteria:

• Are women who are lactating

• Have known allergies to related compounds of LY3841136 or any components of the formulation

• Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions

• Have been diagnosed with Type 1 or Type 2 diabetes mellitus

• Have a history of chronic medical conditions involving the heart, liver, or kidneys

Related Conditions & MeSH terms

• Healthy
• Obesity
• Overweight

Intervention

Drug:
• LY3841136
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit	Dallas	Texas
United States	Fortrea Clinical Research Unit	Daytona Beach	Florida
United States	Fortrea Clinical Research Unit	Madison	Wisconsin

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	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	Predose up to 14 weeks (Part A) & 28 weeks (Part B)
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136	PK: AUC of LY3841136	Predose through week 14 (Part A) & week 28 (Part B)
Secondary	PK: Maximum Observed Concentration (Cmax) of LY3841136	PK: Cmax of LY3841136	Predose through week 14 (Part A) & week 28 (Part B)
Secondary	Pharmacodynamics (PD): Change From Baseline in Body Weight	PD: Change From Baseline in Body Weight	Predose through week 28