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A Study of LY3541105 in Healthy and Overweight Participants

Primary Purpose

Overweight, Healthy

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LY3541105

Placebo

About this trial

This is an interventional basic science trial for Overweight focused on measuring Obesity

Eligibility Criteria

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

Inclusion Criteria:

Participants who are overtly healthy as determined by medical evaluation
Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential
Have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.5 to less than (<) 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)
Have had a stable weight for the last 3 months

Exclusion Criteria:

Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
Have history or current evidence of a clinically significant cardiovascular condition

Sites / Locations

PRA International
ICON Early Phase Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3541105 (Part A)

LY3541105 (Part B)

Placebo (Part A)

Placebo (Part B)

Arm Description

Single ascending doses of LY3541105 administered subcutaneously (SC).

Multiple ascending doses of LY3541105 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 LY3541105

PK: AUC of LY3541105

PK: Time of Maximum observed Concentration (Tmax) of LY3541105

PK: Tmax of LY3541105

PK: Maximum Observed Concentration (Cmax) of LY3541105

PK: Cmax of LY3541105

Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight

PD: Absolute and Percentage Change from Baseline in Body Weight

Full Information

NCT ID

NCT05380323

First Posted

May 1, 2022

Last Updated

October 19, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05380323

Brief Title

A Study of LY3541105 in Healthy and Overweight Participants

Official Title

A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 10, 2022 (Actual)

Primary Completion Date

March 22, 2024 (Anticipated)

Study Completion Date

March 22, 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 LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight. This is a 2-part study and may last up to 15 and 26 weeks for each participant and may include up to 7 and 15 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

Overweight, Healthy

Keywords

Obesity

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

LY3541105 (Part A)

Arm Type

Experimental

Arm Description

Single ascending doses of LY3541105 administered subcutaneously (SC).

Arm Title

LY3541105 (Part B)

Arm Type

Experimental

Arm Description

Multiple ascending doses of LY3541105 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)

LY3541105

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 26 weeks

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105

Description

PK: AUC of LY3541105

Time Frame

Predose through day 43 (Part A) & day 64 (Part B)

Title

PK: Time of Maximum observed Concentration (Tmax) of LY3541105

Description

PK: Tmax of LY3541105

Time Frame

Predose through day 43 (Part A) & day 64 (Part B)

Title

PK: Maximum Observed Concentration (Cmax) of LY3541105

Description

PK: Cmax of LY3541105

Time Frame

Predose through day 43 (Part A) & day 64 (Part B)

Title

Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight

Description

PD: Absolute and Percentage Change from Baseline in Body Weight

Time Frame

Predose through week 26 (Part B Only)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential Have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.5 to less than (<) 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) Have had a stable weight for the last 3 months Exclusion Criteria: Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator Have history or current evidence of a clinically significant cardiovascular condition

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

PRA International

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

Facility Name

ICON Early Phase Services

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of LY3541105 in Healthy and Overweight Participants

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