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
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
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
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
Experimental
Placebo Comparator
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.
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
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
No
Data Monitoring Committee
No
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
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
Email
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
No
Learn more about this trial
A Study of LY3841136 in Healthy and Overweight Participants
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