DRUG
LY3841136
Administered SC.
A Study of LY3841136 in Healthy and Overweight Participants
Status
Completed
Phase
Phase 1
Enrollment
148
Locations
3
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Administered SC.
Timeline
From registration to results.
First posted
Mar 25, 2022
Study start
Mar 30, 2022
Primary completion
Jan 25, 2024
Study completion
Jan 25, 2024
Results posted
Not reported
Registry updated
Apr 1, 2024
Outcomes
What the study measures.
Primary outcomes
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
Time frame · 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 outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136
Time frame · Predose through week 14 (Part A) & week 28 (Part B)
PK: AUC of LY3841136
PK: Maximum Observed Concentration (Cmax) of LY3841136
Time frame · Predose through week 14 (Part A) & week 28 (Part B)
PK: Cmax of LY3841136
Pharmacodynamics (PD): Change From Baseline in Body Weight
Time frame · Predose through week 28
PD: Change From Baseline in Body Weight
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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
Study locations
3 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Fortrea Clinical Research Unit
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit
Dallas, Texas, United States
Fortrea Clinical Research Unit
Madison, Wisconsin, United States
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.