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New diabetes drug aims to help when current meds fall short

NCT ID NCT06897475

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 10 times

Summary

This Phase 2 trial tests an experimental drug called LY3457263 in 240 adults with type 2 diabetes who still have high blood sugar despite taking stable doses of semaglutide or tirzepatide. Participants receive weekly injections of either the new drug or a placebo for about 9 months. The main goal is to see if LY3457263 lowers HbA1c more than placebo.

What this could mean

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

Active substance
LY3457263 (an experimental injectable drug)
What this could lead to
If successful, this could offer a new add-on treatment option for people with type 2 diabetes who need better blood sugar control despite current medications.
What could go wrong
This is an early Phase 2 trial with only 240 participants, so results may not apply to everyone. The drug may not improve HbA1c significantly or could have side effects not yet known.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Started

Mar 2025

Expected to finish

Jun 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 75 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: * Have type 2 diabetes * Have HbA1c ≥7.5% to ≤10.5% at screening * Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening * Have had a stable body weight for the three months prior to screening * On stable treatment dose of one of the following incretins for at least three months prior to screening: * Injectable semaglutide (1 and 2 milligram (mg)) * Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg) Exclusion Criteria: * Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma * Have a prior or planned surgical treatment for obesity * Have any of the following cardiovascular conditions within three months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have used insulin to control blood glucose within the past year (short-term use allowed) * Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening * If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study * Have taken any medications or alternative remedies for weight loss within three months prior to screening

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Conditions

The condition(s) this trial relates to.

Obesity Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes

How to take part

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

  1. The places running it

    56 sites in 6 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

  • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    RECRUITING

    Wroclaw, 50-981, Poland

  • Alliance for Multispecialty Research, LLC

    RECRUITING

    Norman, Oklahoma, 73069, United States

  • Balanced Life Health Care Solutions/SKYCRNG

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • Bluewater Clinical Research Group Inc.

    RECRUITING

    Sarnia, N7T 4X3, Canada

  • Centricity Research Brampton Endocrinology

    RECRUITING

    Brampton, L6S 0C6, Canada

  • Centro de Endocrinologia Alcantara Gonzalez

    RECRUITING

    Bayamón, 00956, Puerto Rico

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    RECRUITING

    Gdansk, 80-546, Poland

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    RECRUITING

    Lodz, 90-338, Poland

  • Clifton Medical Centre

    RECRUITING

    Rotherham, S65 1DA, United Kingdom

  • Clinical Research of Philadelphia

    RECRUITING

    Pennington, New Jersey, 08534, United States

  • Consano Clinical Research, LLC

    RECRUITING

    Shavano Park, Texas, 78231, United States

  • Diabetes Heart Research Centre

    RECRUITING

    Toronto, M6G 1M2, Canada

  • Eastside Research Associates

    RECRUITING

    Redmond, Washington, 98052, United States

  • Ecogene-21

    RECRUITING

    Chicoutimi, G7H 7K9, Canada

  • Ekamed

    RECRUITING

    Lublin, 20-718, Poland

  • Elite Clinical Trials

    RECRUITING

    Rexburg, Idaho, 83440, United States

  • Fadia El Boreky Medicine

    RECRUITING

    Waterloo, N2J 1C4, Canada

  • Frontier Clinical Research, LLC

    RECRUITING

    Scottdale, Pennsylvania, 15683, United States

  • FutureMeds - Birmingham

    RECRUITING

    Birmingham, B21 9RY, United Kingdom

  • FutureMeds - Liverpool

    RECRUITING

    Bromborough, CH62 6EE, United Kingdom

  • Futuremeds-Newcastle

    RECRUITING

    Newcastle, NE6 1SG, United Kingdom

  • G A Research Associates

    RECRUITING

    Moncton, E1G 1A7, Canada

  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

    COMPLETED

    Leipzig, 04249, Germany

  • George Eliot Hospital

    RECRUITING

    Nuneaton, CV10 7DJ, United Kingdom

  • Helios Clinical Research - Phoenix

    RECRUITING

    Phoenix, Arizona, 85028, United States

  • InnoDiab Forschung Gmbh

    COMPLETED

    Essen, 45136, Germany

  • Institut für Diabetesforschung GmbH Münster

    ACTIVE_NOT_RECRUITING

    Münster, 48145, Germany

  • Investigators Research Group

    RECRUITING

    Brownsburg, Indiana, 46112, United States

  • Juno Research

    RECRUITING

    Houston, Texas, 77040, United States

  • Layton Medical Centre

    RECRUITING

    Blackpool, FY3 7EN, United Kingdom

  • Legeartis - Poradnie Specjalistyczne

    RECRUITING

    Bialystok, 15-404, Poland

  • Lucas Research, Inc.

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Maple Leaf Research

    RECRUITING

    Toronto, M5G 1K2, Canada

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    RECRUITING

    Krakow, 31-261, Poland

  • Mgcendo Llc

    RECRUITING

    San Juan, 00921, Puerto Rico

  • NBR Polska

    RECRUITING

    Warsaw, 00-710, Poland

  • NYC Research INC

    RECRUITING

    Long Island City, New York, 11106, United States

  • Newquay Health Centre

    RECRUITING

    Newquay, TR7 1RU, United Kingdom

  • North Georgia Clinical Research

    RECRUITING

    Woodstock, Georgia, 30189, United States

  • Oviedo Medical Research

    RECRUITING

    Oviedo, Florida, 32765, United States

  • Physicians Research Associates

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • Private Practice - Dr. Robert Witek

    RECRUITING

    Tarnów, 33-100, Poland

  • Providence Health Partners-Center for Clinical Research

    RECRUITING

    Dayton, Ohio, 45439, United States

  • RED-Institut GmbH

    ACTIVE_NOT_RECRUITING

    Oldenburg, 23758, Germany

  • Rame Group Practice

    RECRUITING

    Torpoint, PL11 2TB, United Kingdom

  • Renstar Medical Research

    RECRUITING

    Ocala, Florida, 34471, United States

  • Richmond University Medical Center

    RECRUITING

    Staten Island, New York, 10310, United States

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    RECRUITING

    Union City, Georgia, 30291, United States

  • Shelby Clinical Research

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Southern Endocrinology Associates

    RECRUITING

    Mesquite, Texas, 75149, United States

  • Southgate Medical Group

    RECRUITING

    West Seneca, New York, 14224, United States

  • Southmead Hospital

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • Szpital Czerniakowski

    RECRUITING

    Warsaw, 00-737, Poland

  • Texas Diabetes & Endocrinology, P.A.

    RECRUITING

    Round Rock, Texas, 78681, United States

  • Texas Valley Clinical Research

    RECRUITING

    Weslaco, Texas, 78596, United States

  • The Adam Practice

    RECRUITING

    Poole, BH16 5PW, United Kingdom

  • Velocity Clinical Research, Leipzig

    RECRUITING

    Leipzig, 04177, Germany

  • Viacar Recherche Clinique

    RECRUITING

    Longueuil, J4H 4B9, Canada

  • Winterberry Research Inc.

    RECRUITING

    Hamilton, L8J 0B6, Canada

  • Wolverine Clinical Trials

    RECRUITING

    Santa Ana, California, 92706, United States

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Other studies related to the condition(s) this trial covers.