A Study of LY3841136 in Healthy and Overweight Participants

Phase 1

Completed

• Conditions: Obesity; Healthy
• Interventions: Drug: LY3841136; Drug: Placebo

• Registration Number: NCT05295940
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-03-25
• Study Start: 2022-03-30
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3841136 (Part B)	LY3841136	Multiple ascending doses of LY3841136 administered SC.
Placebo (Part A)	Placebo	Placebo administered SC.
LY3841136 (Part A)	LY3841136	Single ascending doses of LY3841136 administered subcutaneously (SC).
Placebo (Part B)	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
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	Predose up to 14 weeks (Part A) & 28 weeks (Part B)	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fortrea Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States