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Can a new injectable drug pass its first human safety test?

NCT ID NCT07767487

Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called LY4226695 in healthy volunteers to see how safe it is and what side effects it might cause. Participants receive either the drug or a placebo, given as an injection under the skin or into a vein. The study also measures how the body absorbs, processes, and eliminates the drug. Results will help determine whether further testing in patients is warranted.

What this could mean

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

Active substance
LY4226695, an experimental drug given by injection under the skin or into a vein
What this could lead to
If successful, this early study could pave the way for further testing of LY4226695 as a potential treatment for future conditions.
What could go wrong
This is a very early Phase 1 trial in a small number of healthy people, so it is primarily about safety and dosing. The drug may cause side effects, and its effectiveness for any disease is unknown.

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 148 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

Jul 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

22 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: * Have a screening body mass index (BMI) in the range of 18.5 to 35 kilograms per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening. * Individuals assigned male at birth must agree to adhere to contraception restrictions and individuals assigned female at birth must not be of childbearing potential. * Part B Chinese participants: * To qualify as a Chinese participant for the purpose of this study, all the participants' biological grandparents must be Chinese and born in China. * Part C Japanese participants: * To qualify as a Japanese participant for the purpose of this study, all the participants' biological grandparents must be Japanese and born in Japan. Exclusion Criteria: * Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders. * Have known or ongoing psychiatric disorders. * Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children). * Have a history of fracture within 6 months prior to screening. * Have a history of fainting. * Regularly use known drugs of abuse or with positive drug results. * Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation.

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As listed by the trial registrant

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

Healthy

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • CenExel ACT

    Anaheim, California, 92801, United States

  • Lilly Centre for Clinical Pharmacology

    Singapore, 138623, Singapore

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