A Study of LY3841136 in Healthy and Overweight Participants

NCT05295940
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Phase
Phase 1
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Recruitment status
Completed
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Participants
148
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Lead sponsor
Eli Lilly and Company
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Start date
2022-03-30
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Number of sites
3
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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.
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Short title
A Study of LY3841136 in Healthy and Overweight Participants
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Official title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2024-01-25
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First posted
2022-03-25
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Registry last updated
2024-04-01
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Primary completion date
2024-01-25
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Start date
2022-03-30
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Actual participants
148
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Participants
148
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
3
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05295940
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ClinicalTrials.gov ID
NCT05295940
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. 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

    Timeframe: 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

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136

    Timeframe: Predose through week 14 (Part A) & week 28 (Part B)

    PK: AUC of LY3841136

  2. PK: Maximum Observed Concentration (Cmax) of LY3841136

    Timeframe: Predose through week 14 (Part A) & week 28 (Part B)

    PK: Cmax of LY3841136

  3. Pharmacodynamics (PD): Change From Baseline in Body Weight

    Timeframe: Predose through week 28

    PD: Change From Baseline in Body Weight

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • 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)

  • 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
Sources for eligibility
clinicaltrials.gov

  • Fortrea Clinical Research UnitDaytona Beach, United States
  • Fortrea Clinical Research UnitDallas, United States
  • Fortrea Clinical Research UnitMadison, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J3R-MC-YDAA
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)