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A Study of LY3841136 in Healthy and Overweight Participants

Primary Purpose

Obesity, Healthy

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LY3841136

Placebo

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Covance Clinical Research UnitRecruiting
Covance DallasRecruiting
Covance Clinical Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3841136 (Part A)

LY3841136 (Part B)

Placebo (Part A)

Placebo (Part B)

Arm Description

Single ascending doses of LY3841136 administered subcutaneously (SC).

Multiple ascending doses of LY3841136 administered SC.

Placebo administered SC.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136

PK: AUC of LY3841136

PK: Maximum Observed Concentration (Cmax) of LY3841136

PK: Cmax of LY3841136

Pharmacodynamics (PD): Change From Baseline in Body Weight

PD: Change From Baseline in Body Weight

Full Information

NCT ID

NCT05295940

First Posted

March 24, 2022

Last Updated

October 18, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05295940

Brief Title

A Study of LY3841136 in Healthy and Overweight Participants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2022 (Actual)

Primary Completion Date

August 7, 2024 (Anticipated)

Study Completion Date

August 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LY3841136 (Part A)

Arm Type

Experimental

Arm Description

Single ascending doses of LY3841136 administered subcutaneously (SC).

Arm Title

LY3841136 (Part B)

Arm Type

Experimental

Arm Description

Multiple ascending doses of LY3841136 administered SC.

Arm Title

Placebo (Part A)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC.

Arm Title

Placebo (Part B)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC.

Intervention Type

Drug

Intervention Name(s)

LY3841136

Intervention Description

Administered SC.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC.

Primary Outcome Measure Information:

Title

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

Description

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time Frame

Predose up to 14 weeks (Part A) & 28 weeks (Part B)

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136

Description

PK: AUC of LY3841136

Time Frame

Predose through week 14 (Part A) & week 28 (Part B)

Title

PK: Maximum Observed Concentration (Cmax) of LY3841136

Description

PK: Cmax of LY3841136

Time Frame

Predose through week 14 (Part A) & week 28 (Part B)

Title

Pharmacodynamics (PD): Change From Baseline in Body Weight

Description

PD: Change From Baseline in Body Weight

Time Frame

Predose through week 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone

1-317-615-4559

ClinicalTrials.gov@Lilly.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Covance Clinical Research Unit

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen Doisy

Facility Name

Covance Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75247

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

214-647-9300

First Name & Middle Initial & Last Name & Degree

Gene Voskuhl

Facility Name

Covance Clinical Research Unit

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

608-210-5454

First Name & Middle Initial & Last Name & Degree

Nicholas Siebers

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of LY3841136 in Healthy and Overweight Participants

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