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RecruitingNCT07765498Updated Sep 22, 2026

A Study of LY4355756 in Healthy Participants

A Phase 1 interventional study of LY4355756 and LY4355756 in Healthy, sponsored by Eli Lilly and Company. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
123 participants (estimated)

Study arms

  • Experimental
    LY4355756 Part A

    Single-ascending dose (SAD) of LY4355756 administered orally

    Drug: LY4355756

  • Experimental
    LY4355756 Part B

    Multiple-ascending doses (MAD) of LY4355756 administered orally

    Drug: LY4355756

  • Experimental
    LY4355756 Part C

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

    Drug: LY4355756

  • Experimental
    LY4355756 + Midazolam Part D

    LY4355756 and midazolam co-administered orally

    Drug: LY4355756 · Drug: Midazolam

  • Experimental
    Midazolam Part D

    Midazolam administered orally

    Drug: Midazolam

Interventions

  • DrugLY4355756

    Administered orally as capsule

  • DrugLY4355756

    Administered orally as tablet

  • DrugMidazolam

    Administered orally as liquid

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
    • · Contact · 469-513-6669
    • Gene Voskuhl · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07765498
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 17, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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