Could a new oral drug change future treatments? early safety trial begins
NCT ID NCT07765498
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 123 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fortrea Clinical Research Unit
Dallas, Texas, 75247, United States
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