ClinicalTrials.gg
RecruitingNCT07765498Updated Oct 8, 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 2026-10-08.

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

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

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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

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, (ECGs), and vital signs
  • Have a 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)

    • 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 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 within 5 years prior to screening

    • Exceptions:

      • basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of 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 virus (HBV), virus (HCV), and (HIV)
  • Have received any live (including attenuated ), 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
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

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

  • Administered orally as liquid

06

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

07

Study locations

1 of 1 sites recruiting
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
    Recruiting
    • · Contact866-429-3700
    • Gene Voskuhl · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Jan 2027, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 14, 2026
StartActual
Aug 17, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Site contacts
Changed at 1 site. See the sites
Show the site
  • Fortrea Clinical Research Unit · Dallas, United StatesContact •••6669→•••3700
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Fortrea Clinical Research Unit · Dallas, United StatesContact •••6669→•••3700
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07765498
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 17, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 8, 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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Discussion

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Studies of the drug tested here: Midazolam

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