Recruiting
Phase 1

LY4178256

Sponsor:

Eli Lilly and Company

Code:

NCT07698210

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

LY4178256

Placebo

Study Details

Brief summary:

The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.

Conditions

Healthy Volunteers

Study ID

NCT07698210

Start date

Jul 16, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, and other screening procedures.
  • Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg/m²)
  • Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial.

Exclusion Criteria:

  • Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data.
  • Have abnormal blood pressure
  • Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (>450 msec) for males, or >470 msec for females.
  • Regularly use known drugs of abuse or with positive drug results (within the past 3 months).
  • Have a positive ethanol breath/urine test result or positive urine drugs of abuse screen at screening or check-in.
  • Have hemoglobin level less than 12 grams per deciliter (<12 g/dL), or evidence of iron deficiency (ferritin less than 30 nanograms per milliliter (<30 ng/mL), or history or presence of hemoglobinopathy, or history hemolytic anemia. Participants who received transfusion within the past 12 weeks, or requiring regular transfusion should be excluded.
  • Have clinically significant abnormal liver function tests at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP), or total bilirubin ≥1.5x upper limit normal (ULN). Participants with confirmed Gilbert's syndrome may be enrolled.
  • Have significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per square meter (eGFR<60mL/min/1.73 m ²)).

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b)

LY4178256 or Placebo administered Intravenously (IV)

experimental: LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3)

LY4178256 or Placebo administered IV

Interventions

LY4178256

Administered intravenously (IV)

Placebo

Administered IV

Primary outcome measure

  • Part A: 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: Screening to Day 169 ]
  • Part B: 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: Screening to Day 197 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

ICON

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

801-904-4600

Principal Investigator:

Ahad Sabet

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-20.