A Study of LY4515100 in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT07339722
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY4515100 via SAD — DRUG
    given orally
  • LY4515100 via MAD — DRUG
    given orally
  • LY4515100 — DRUG
    given orally
  • Itraconazole — DRUG
    given orally
  • Caffeine — DRUG
    given orally
  • Digoxin — DRUG
    given orally
  • Iohexol — DRUG
    given IV
  • Metformin — DRUG
    given orally
  • Rosuvastatin — DRUG
    given orally
  • Placebo — DRUG
    given orally

Study Details

The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. LY4515100 will be given by itself or with other medicines. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will have 3 parts and will last about 50 days. For each participant in Part A, the study will include a stay in the Clinical Research Unit (CRU) lasting about 6 days. For each participant in Part B, the study will include a stay in the CRU lasting about 15 days. For each participant in Part C, the study will include up to 2 stays in the CRU each lasting between 7-28 days.

Key Dates

First listed
Jan 14, 2026
Start date
Jan 15, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: LY4515100 of Part A (SAD)
    Single-ascending doses of LY4515100 will be given orally
  • Experimental: LY4515100 of Part B (MAD)
    Multiple-ascending doses of LY4515100 will be given orally
  • Experimental: LY4515100 and Itraconazole of Part C
    LY4515100 and Itraconazole will be given orally
  • Experimental: LY4515100 and Metformin of Part C
    LY4515100 and Metformin will be given orally
  • Experimental: LY4515100 and Transporter Substrates or Renal Marker of Part C
    LY4515100 and Transporter Substrates or Renal Marker will be given either orally or intravenously (IV)
  • Placebo Comparator: Placebo Part A
    Placebo will be given orally
  • Placebo Comparator: Placebo Part B
    Placebo will be given orally

Primary Outcome Measure

Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 in Parts A and B [ Time Frame: Day 1 up to Day 30 ]

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 (1)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research UnitDallasTexas75247
866-429-3700
Gene Voskuhl (PRINCIPAL_INVESTIGATOR)

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By research site
Fortrea Clinical Research Unit· Dallas, TX

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