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New diabetes pill shows promise in early safety trial

NCT ID NCT06869018

Disease control 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new oral drug called LY3549492 in 92 Japanese volunteers, some with type 2 diabetes and some healthy. The main goal was to check safety and how the body processes the drug. Participants took multiple doses over several weeks, and researchers monitored side effects and drug levels in the blood.

What this could mean

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

Active substance
LY3549492 (oral drug)
What this could lead to
If successful, this could lead to a new oral medication to help control blood sugar in people with type 2 diabetes.
What could go wrong
This is an early Phase 1 trial focused on safety, not effectiveness. The drug may not work as hoped or could have side effects. Results may not apply to non-Japanese populations.

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

92 people

The number who actually took part.

Started

May 2025

Finished

Mar 2026

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 70 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: Part A: * Participants with T2DM for at least 6 months * With an HbA1c value: * equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR * equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications * Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change Part B: * Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results Exclusion Criteria: * Have a known clinically significant gastric emptying abnormality * Have a 12-lead electrocardiogram (ECG) abnormality * Have an abnormal blood pressure or pulse rate * Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug * Have a history of chronic medical conditions involving the heart, liver, or kidneys

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Conditions

The condition(s) this trial relates to.

diabetes mellitus endocrine system disorder glucose metabolism disease metabolic disease type 2 diabetes mellitus

As listed by the trial registrant

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

Healthy Type 2 diabetes mellitus (T2D)

Contacts and locations

Locations

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, 160-0004, Japan

  • Hakata Clinic

    Fukuoka, 812-0025, Japan

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka, 532-0003, Japan

  • P-One Clinic

    Hachiōji, 192-0071, Japan

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