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NCT Number: NCT07765498

A Study of LY4355756 in Healthy Participants

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.

Recruiting

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location status: Recruiting

Location contact

Gene Voskuhl

PRINCIPAL_INVESTIGATOR

CONTACT

469-513-6669

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4355756

Drug

Administered orally as capsule

midazolam

Drug

Administered orally as liquid

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4355756

    Time frame: Baseline up to Day 18

  2. PK: Maximum Plasma Concentration (Cmax) of LY4355756

    Time frame: Baseline up to Day 18

  3. PK: AUC of Midazolam

    Time frame: Baseline up to Day 14

  4. PK: Cmax of Midazolam

    Time frame: Baseline up to Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY4355756 in Healthy Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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