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New oral weight loss pill shows promise in Mid-Stage trial

NCT ID NCT06579092

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new daily pill called AZD5004 for weight loss in 310 adults with obesity or overweight who also had a weight-related health problem like high blood pressure. Participants took either the drug or a placebo for 36 weeks. The main goal was to see if the drug helped people lose more weight than the placebo.

What this could mean

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

Active substance
AZD5004 (oral tablet)
What this could lead to
If successful, this could lead to a new daily pill for weight loss in people with obesity or weight-related health issues.
What could go wrong
This is a Phase II trial, so it's still early. The drug may not work better than placebo, or side effects could limit its use. Results may not apply to everyone.

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

310 people

The number who actually took part.

Started

Oct 2024

Finished

Nov 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. * BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated): (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea * A stable body weight for 3 months prior to Screening (± 5% body weight change). Exclusion Criteria: * Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome. * Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening. * Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier). * History of type 1 diabetes mellitus or type 2 diabetes mellitus. * Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract. * History of acute or chronic pancreatitis.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

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

Obesity or overweight

Contacts and locations

Locations

  • Research Site

    Chandler, Arizona, 85225, United States

  • Research Site

    Huntington Park, California, 90255, United States

  • Research Site

    La Mesa, California, 91942, United States

  • Research Site

    Lincoln, California, 95648, United States

  • Research Site

    Walnut Creek, California, 94598, United States

  • Research Site

    Hialeah, Florida, 33012, United States

  • Research Site

    Orlando, Florida, 32806, United States

  • Research Site

    Lombard, Illinois, 60148, United States

  • Research Site

    Valparaiso, Indiana, 46383, United States

  • Research Site

    West Des Moines, Iowa, 50266, United States

  • Research Site

    Roslindale, Massachusetts, 02131, United States

  • Research Site

    Farmington Hills, Michigan, 48334, United States

  • Research Site

    Chesterfield, Missouri, 63005, United States

  • Research Site

    Omaha, Nebraska, 68134, United States

  • Research Site

    Vestal, New York, 13850, United States

  • Research Site

    Durham, North Carolina, 27701, United States

  • Research Site

    Wilmington, North Carolina, 28401, 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

    North Charleston, South Carolina, 29405, United States

  • Research Site

    Spartanburg, South Carolina, 29303, United States

  • Research Site

    Knoxville, Tennessee, 37912, United States

  • Research Site

    Austin, Texas, 78735, United States

  • Research Site

    Dallas, Texas, 75230, United States

  • Research Site

    Houston, Texas, 77040, United States

  • Research Site

    Woodway, Texas, 76712, United States

  • Research Site

    Ogden, Utah, 84405, United States

  • Research Site

    Charlottesville, Virginia, 22911, United States

  • Research Site

    Manassas, Virginia, 20110, United States

  • Research Site

    Heidelberg, 3081, Australia

  • Research Site

    Merewether, 2291, Australia

  • Research Site

    St Albans, 3021, Australia

  • Research Site

    St Leonards, 2065, Australia

  • Research Site

    Calgary, Alberta, T2V 4J2, Canada

  • Research Site

    Surrey, British Columbia, V3T 2V6, Canada

  • Research Site

    Victoria, British Columbia, V8V 4A1, Canada

  • Research Site

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Research Site

    Guelph, Ontario, N1G 0B4, Canada

  • Research Site

    Hamilton, Ontario, L8J 0B6, Canada

  • Research Site

    Hamilton, Ontario, L8L 5G8, Canada

  • Research Site

    Toronto, Ontario, M9V 4B4, Canada

  • Research Site

    Toronto, Ontario, M9W 4L6, Canada

  • Research Site

    Terrebonne, Quebec, J6X 4P7, Canada

  • Research Site

    Bad Oeynhausen, 32545, Germany

  • Research Site

    Berlin, 10787, Germany

  • Research Site

    Hamburg, 22607, Germany

  • Research Site

    Mannheim, 68167, Germany

  • Research Site

    Münster, 48145, Germany

  • Research Site

    Oldenburg, 23758, Germany

  • Research Site

    Sankt Ingbert, 66386, Germany

  • Research Site

    Suita-shi, 565-0853, Japan

  • Research Site

    Kaohsiung City, 807, Taiwan

  • Research Site

    Taichung, 40447, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10048, Taiwan

  • Research Site

    Blackpool, FY3 7EN, United Kingdom

  • Research Site

    Bristol, BS34 6BQ, United Kingdom

  • Research Site

    Chesterfield, S40 4AA, United Kingdom

  • Research Site

    Leicester, Le5 4PW, United Kingdom

  • Research Site

    Rotherham, S65 1DA, United Kingdom

  • Research Site

    Witney, OX28 6JS, United Kingdom

More trials for these conditions

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