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New oral diabetes drug shows promise in early safety trial

NCT ID NCT05086445

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests an experimental oral drug called LY3502970 in Japanese adults with type 2 diabetes. The main goal is to check for side effects and see how the body processes the drug. Participants take either the drug or a placebo and are monitored over up to 24 weeks with blood tests and clinic visits.

What this could mean

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

Active substance
an experimental oral drug called LY3502970
What this could lead to
If successful, this could lead to a new oral medication option for managing blood sugar in people with type 2 diabetes.
What could go wrong
This is an early phase 1 trial focused on safety, so it is too soon to know if the drug works well. Side effects are possible and being studied.

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

62 people

The number who actually took part.

Started

Nov 2021

Finished

Sep 2022

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

20 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Males and females not of childbearing potential * Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year * Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤ 10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at screening * Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing. Exclusion Criteria: * Have type 1 diabetes mellitus or latent autoimmune diabetes in adults. * Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization * Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligram per deciliter (mg/dL). * Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 3× upper limit of normal (ULN).

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus, type 2

Contacts and locations

Locations

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 162-0053, Japan

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka, Osaka, 532-0003, Japan

  • Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic

    Toshima City, Tokyo, 171-0014, Japan

  • P-One Clinic

    Hachiōji, Tokyo, 192-0071, Japan

  • Yokohama Minoru Clinic

    Yokohama, 232-0064, Japan

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