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New diabetes drug shows promise in Mid-Stage trial

NCT ID NCT06579105

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called AZD5004 in 406 adults with type 2 diabetes. The goal was to see if it helps lower blood sugar better than a placebo or an existing diabetes drug. Participants had to have had diabetes for at least 6 months and be on diet, exercise, or stable doses of certain other medications. The main focus was on changes in HbA1c, a key measure of long-term blood sugar control.

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

406 people

The number who actually took part.

Started

Oct 2024

Finished

Dec 2025

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 years and older

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: Adults ≥ 18 years of age. Diagnosed with T2DM for at least 6 months. HbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening. Body mass index of ≥ 23 kg/m2. Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change). Exclusion Criteria: Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma. History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment. Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Received medication for weight loss within the last 3 months prior to screening. Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier). History of acute or chronic pancreatitis.

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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

  • Research Site

    Mobile, Alabama, 36608, United States

  • Research Site

    Sheffield, Alabama, 35660, United States

  • Research Site

    Vestavia Hills, Alabama, 35216, United States

  • Research Site

    Tucson, Arizona, 85710, United States

  • Research Site

    Little Rock, Arkansas, 72205, United States

  • Research Site

    Long Beach, California, 90815, United States

  • Research Site

    Los Angeles, California, 90017, United States

  • Research Site

    Newport Beach, California, 92660, United States

  • Research Site

    Sacramento, California, 95821, United States

  • Research Site

    Waterbury, Connecticut, 06708, United States

  • Research Site

    Lake City, Florida, 32055, United States

  • Research Site

    Largo, Florida, 33777, United States

  • Research Site

    Ocoee, Florida, 34761, United States

  • Research Site

    Orlando, Florida, 32804, United States

  • Research Site

    Decatur, Georgia, 30030, United States

  • Research Site

    Savannah, Georgia, 31406, United States

  • Research Site

    Lombard, Illinois, 60148, United States

  • Research Site

    Potomac, Maryland, 20854, United States

  • Research Site

    Boston, Massachusetts, 02115, United States

  • Research Site

    Roslindale, Massachusetts, 02131, United States

  • Research Site

    Farmington Hills, Michigan, 48334, United States

  • Research Site

    Gulfport, Mississippi, 39503, United States

  • Research Site

    Kansas City, Missouri, 64111, United States

  • Research Site

    Omaha, Nebraska, 68134, United States

  • Research Site

    Las Vegas, Nevada, 89109, United States

  • Research Site

    Albuquerque, New Mexico, 87107, United States

  • Research Site

    Binghamton, New York, 13905, United States

  • Research Site

    Durham, North Carolina, 27701, United States

  • Research Site

    Greensboro, North Carolina, 27408, United States

  • Research Site

    Rocky Mount, North Carolina, 27804, United States

  • Research Site

    Statesville, North Carolina, 28625, United States

  • Research Site

    Wilmington, North Carolina, 28401, United States

  • Research Site

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    Fargo, North Dakota, 58104, United States

  • Research Site

    Beachwood, Ohio, 44122, United States

  • Research Site

    Cincinnati, Ohio, 45219, United States

  • Research Site

    Medford, Oregon, 97504, United States

  • Research Site

    West Chester, Pennsylvania, 19380, United States

  • Research Site

    Gaffney, South Carolina, 29340, United States

  • Research Site

    Bristol, Tennessee, 37620, United States

  • Research Site

    Abilene, Texas, 79606, United States

  • Research Site

    Dallas, Texas, 75230, United States

  • Research Site

    El Paso, Texas, 79935, United States

  • Research Site

    Houston, Texas, 77004, United States

  • Research Site

    West Jordan, Utah, 84088, United States

  • Research Site

    Charlottesville, Virginia, 22911, United States

  • Research Site

    Manassas, Virginia, 20110, United States

  • Research Site

    Norfolk, Virginia, 23504, United States

  • Research Site

    Seattle, Washington, 98105, United States

  • Research Site

    Kingwood, West Virginia, 26537, United States

  • Research Site

    Surrey, British Columbia, V3T 2V6, Canada

  • Research Site

    Brampton, Ontario, L6T 0G1, Canada

  • Research Site

    Burlington, Ontario, L7M 4Y1, Canada

  • Research Site

    Sarnia, Ontario, N7T 4X3, Canada

  • Research Site

    Toronto, Ontario, M9V 4B4, Canada

  • Research Site

    Lévis, Quebec, G6V 6E2, Canada

  • Research Site

    Falkensee, 14612, Germany

  • Research Site

    Hamburg, 22607, Germany

  • Research Site

    Münster, 48145, Germany

  • Research Site

    Oldenburg, 23758, Germany

  • Research Site

    Sankt Ingbert, 66386, Germany

  • Research Site

    Wangen, 88239, Germany

  • Research Site

    Budapest, 1036, Hungary

  • Research Site

    Budapest, 1083, Hungary

  • Research Site

    Debrecen, 4032, Hungary

  • Research Site

    Szeged, 6725, Hungary

  • Research Site

    Chūōku, 103-0027, Japan

  • Research Site

    Chūōku, 104-0031, Japan

  • Research Site

    Matsuyama, 7900034, Japan

  • Research Site

    Shinjuku-ku, 160-0008, Japan

  • Research Site

    Bialystok, 15-435, Poland

  • Research Site

    Krakow, 31-156, Poland

  • Research Site

    Krakow, 31-261, Poland

  • Research Site

    Lodz, 90-338, Poland

  • Research Site

    Lublin, 20-718, Poland

  • Research Site

    Poznan, 60-589, Poland

  • Research Site

    Poznan, 61-655, Poland

  • Research Site

    Tarnów, 33-100, Poland

  • Research Site

    Bratislava, 831 03, Slovakia

  • Research Site

    Prešov, 080 01, Slovakia

  • Research Site

    Rožňava, 048 01, Slovakia

  • Research Site

    Sabinov, 083 01, Slovakia

  • Research Site

    Trebišov, 07501, Slovakia

  • Research Site

    A Coruña, 15006, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Madrid, 28006, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Seville, 41003, Spain

  • Research Site

    Seville, 41010, Spain

  • Research Site

    Seville, 41950, Spain

  • Research Site

    Blackpool, FY3 7EN, United Kingdom

  • Research Site

    Bristol, BS34 6BQ, United Kingdom

  • Research Site

    Chesterfield, S40 4AA, United Kingdom

  • Research Site

    Corby, NN17 2UR, United Kingdom

  • Research Site

    Dundee, DD1 9SY, United Kingdom

  • Research Site

    Rotherham, S65 1DA, United Kingdom

  • Research Site

    Yate, BS37 4AX, United Kingdom

More trials for these conditions

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