A Study of LY4088044 in Healthy Participants

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Eli Lilly and Company
Study ID
NCT07090785
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY4088044 — DRUG
    Administered IV
  • LY4088044 — DRUG
    Administered SC
  • Placebo — DRUG
    Administered IV
  • Placebo — DRUG
    Administered SC

Study Details

The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.

Key Dates

Start date
Jul 24, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY4088044 (Part A)
    Single-ascending dose (SAD) of LY4088044 administered intravenously (IV)
  • Placebo Comparator: Placebo (Part A)
    Administered IV
  • Experimental: LY4088044 (Part B)
    SAD of LY4088044 administered subcutaneously (SC)
  • Placebo Comparator: Placebo (Part B)
    Administered SC
  • Experimental: LY4088044 (Part C)
    Multiple-ascending doses (MAD) of LY4088044 administered IV
  • Placebo Comparator: Placebo (Part C)
    Administered IV

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Approximately Day 190 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Collaborative Neuroscience Network - CNSLos AlamitosCalifornia90720
844-424-9494
Steven Reynolds (PRINCIPAL_INVESTIGATOR)
ICONLenexaKansas66219
913-205-4397
Patrick Yao (PRINCIPAL_INVESTIGATOR)
ICON Early Phase ServicesSan AntonioTexas78232
210-283-4156
Chinonye Ogbonnaya-Odor (PRINCIPAL_INVESTIGATOR)
ICONSalt Lake CityUtah84124
801-269-8200
Ahad Sabet (PRINCIPAL_INVESTIGATOR)

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Collaborative Neuroscience Network - CNS· Los Alamitos, CAICON· Lenexa, KSICON Early Phase Services· San Antonio, TXICON· Salt Lake City, UT

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