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Could a new oral drug change future treatments? early safety trial begins

NCT ID NCT07765498

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This early-stage trial is testing an investigational drug called LY4355756 in healthy volunteers to see how safe it is and how the body absorbs it. Participants will receive the drug as an oral capsule or tablet, with some also receiving midazolam to check for drug interactions. The study involves several short stays at a research unit to monitor safety and drug levels. The goal is to gather essential safety data to support further development of this potential medicine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4355756, an investigational drug given as an oral capsule or tablet
What this could lead to
If successful, this early study could pave the way for further testing of LY4355756 as a potential treatment for future conditions.
What could go wrong
This is a very early, small study focused on safety and drug processing in healthy people, not on treating any disease. The drug may not prove safe or effective in later trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 123 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fortrea Clinical Research Unit

    Dallas, Texas, 75247, United States

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