- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05295940
A Study of LY3841136 in Healthy and Overweight Participants
January 2, 2024 updated by: Eli Lilly and Company
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
160
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: ClinicalTrials.gov@lilly.com
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Fortrea Clinical Research Unit
-
-
Texas
-
Dallas, Texas, United States, 75247
- Fortrea Clinical Research Unit
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53704
- Fortrea Clinical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY3841136 (Part A)
Single ascending doses of LY3841136 administered subcutaneously (SC).
|
Administered SC.
|
Experimental: LY3841136 (Part B)
Multiple ascending doses of LY3841136 administered SC.
|
Administered SC.
|
Placebo Comparator: Placebo (Part A)
Placebo administered SC.
|
Administered SC.
|
Placebo Comparator: Placebo (Part B)
Placebo administered SC.
|
Administered SC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Predose up to 14 weeks (Part A) & 28 weeks (Part B)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Predose through week 14 (Part A) & week 28 (Part B)
|
PK: Maximum Observed Concentration (Cmax) of LY3841136
Time Frame: Predose through week 14 (Part A) & week 28 (Part B)
|
PK: Cmax of LY3841136
|
Predose through week 14 (Part A) & week 28 (Part B)
|
Pharmacodynamics (PD): Change From Baseline in Body Weight
Time Frame: Predose through week 28
|
PD: Change From Baseline in Body Weight
|
Predose through week 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2022
Primary Completion (Estimated)
January 25, 2024
Study Completion (Estimated)
January 25, 2024
Study Registration Dates
First Submitted
March 24, 2022
First Submitted That Met QC Criteria
March 24, 2022
First Posted (Actual)
March 25, 2022
Study Record Updates
Last Update Posted (Actual)
January 3, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18309
- J3R-MC-YDAA (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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