Recruiting
Phase 1

LY4355756

Sponsor:

Eli Lilly and Company

Code:

NCT07765498

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

LY4355756

LY4355756

Midazolam

Study Details

Brief summary:

The purpose of the study is to assess how LY4355756 is absorbed by the body and how safe it is to healthy participants.

There will be four inpatient stays at the clinical research unit (CRU). For Part A there will be 5 continuous days, Part B 22 continuous days, Part C 5 continuous days in each of the 3 periods, and Part D 18 continuous days in the CRU.

Conditions

Healthy

Study ID

NCT07765498

Start date

Aug 17, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

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, laboratory tests, electrocardiogram (ECGs), and vital signs
  • Have a body mass index within the range 18.0-32.0 kilograms per square meter (kg/m²) (inclusive)
  • Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB)

  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:

  • Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders, or abnormal laboratory values at screening
  • Have an abnormality in 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participating in the study or may confound ECG data analysis
  • Have a diagnosis or history of malignancy within 5 years prior to screening

  • Exceptions:

  • basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening
  • Have had breast cancer within the past 10 years
  • Have a history or presence of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food
  • Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization visit, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment
  • Have a current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
  • Have received any live (including attenuated live vaccines), non-live, or inactivated vaccine(s) within less than 4 weeks before randomization or intend to receive them during the study
  • Are individuals AFAB who, during the study, are pregnant, have positive pregnancy testing, intend to become pregnant, are lactating, or intend to breastfeed

Study Design

Enrollment

123 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4355756 Part A

Single-ascending dose (SAD) of LY4355756 administered orally

experimental: LY4355756 Part B

Multiple-ascending doses (MAD) of LY4355756 administered orally

experimental: LY4355756 Part C

Single dose of LY4355756 administered orally in each of three study periods

experimental: LY4355756 + Midazolam Part D

LY4355756 and midazolam co-administered orally

experimental: Midazolam Part D

Midazolam administered orally

Interventions

LY4355756

Administered orally as capsule

LY4355756

Administered orally as tablet

Midazolam

Administered orally as liquid

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 the Safety Follow up Visit (6 months) ]
  • Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to the Safety Follow up Visit (6 months) ]

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

Fortrea Clinical Research Unit

Recruiting

Dallas, Texas, United States, 75247

Contacts

469-513-6669

Principal Investigator:

Gene Voskuhl

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.