A Study of LY3841136 in Healthy and Overweight Participants
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3841136 (Part A) Single ascending doses of LY3841136 administered subcutaneously (SC). |
Drug: LY3841136
Administered SC.
|
| Experimental: LY3841136 (Part B) Multiple ascending doses of LY3841136 administered SC. |
Drug: LY3841136
Administered SC.
|
| Placebo Comparator: Placebo (Part A) Placebo administered SC. |
Drug: Placebo
Administered SC.
|
| Placebo Comparator: Placebo (Part B) Placebo administered SC. |
Drug: Placebo
Administered SC.
|
Outcome Measures
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 [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
- 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
- PK: Maximum Observed Concentration (Cmax) of LY3841136 [Predose through week 14 (Part A) & week 28 (Part B)]
PK: Cmax of LY3841136
- Pharmacodynamics (PD): Change From Baseline in Body Weight [Predose through week 28]
PD: Change From Baseline in Body Weight
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LabCorp CRU, Inc. | Daytona Beach | Florida | United States | 32117 |
| 2 | Covance Dallas | Dallas | Texas | United States | 75247 |
| 3 | Covance Clinical Research Unit | Madison | Wisconsin | United States | 53704 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18309
- J3R-MC-YDAA