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Cure My Disease

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New weekly shot could help millions shed pounds and control diabetes

NCT ID NCT07284901

Disease control Sponsor: Kailera 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This Phase 3 trial tests a new drug called KAI-9531, given as a weekly injection, in 1700 adults who are overweight or obese and have type 2 diabetes. The study compares KAI-9531 to a placebo to see if it leads to greater weight loss and better blood sugar control over 76 weeks. Participants must have tried and failed to lose weight before.

What this could mean

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

Active substance
KAI-9531
What this could lead to
If successful, this could offer a new once-weekly injection to help people with obesity and diabetes lose weight and improve blood sugar control.
What could go wrong
This is a large Phase 3 trial, but the drug is still experimental. It may not prove superior to placebo, and side effects are possible. 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,156 people

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

Started

Jan 2026

Expected to finish

Apr 2028

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 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.

Key Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus (T2DM). * Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive. * BMI ≥27 kg/m\^2. * History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months. Key Exclusion Criteria: * Current diagnosis or history of type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM. * History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening. * History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening. * Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, or phentermine. * Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening. * Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer. * Uncontrolled hypertension or unstable cardiovascular disease. * History of chronic or acute pancreatitis. * Known clinically significant gastric emptying abnormality or chronic treatment with medications that directly affect gastrointestinal (GI) motility if taken for \>30 days continually within 3 months prior to Screening. * History of suicide attempt. * History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening. * Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Obesity with diabetes Overweight with diabetes

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    165 sites in 11 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Kailea Clinical Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Kailera Clinical Site

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Kailera Clinical Site

    RECRUITING

    Castilleja de la Cuesta, Sevilla, 41950, Spain

  • Kailera Clinical Site

    RECRUITING

    Madrid, 28003, Spain

  • Kailera Clinical Site

    RECRUITING

    Seville, 41003, Spain

  • Kailera Clinical Site

    RECRUITING

    Seville, 41013, Spain

  • Kailera Clinical Site

    RECRUITING

    Valencia, 46014, Spain

  • Kailera Clinical Site

    RECRUITING

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Bournemouth, Dorset, BH7 7DW, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Hull, East Yorkshire, HU3 2JZ, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Glasgow, Glasgow City, G51 4TF, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    London, Greater London, EC1M 6BQ, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Stevenage, Hertfordshire, SG1 4AB, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Nottingham, Nottinghamshire, NG7 2QW, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Yate, South Gloucestershire, BS37 4AX, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Bradford, West Yorkshire, BD9 6RJ, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Cullman, Alabama, 35055, United States

  • Kailera Clinical Site

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Kailera Clinical Site

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Kailera Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Kailera Clinical Site

    RECRUITING

    Escondido, California, 92025, United States

  • Kailera Clinical Site

    RECRUITING

    La Mesa, California, 91942, United States

  • Kailera Clinical Site

    RECRUITING

    Montclair, California, 91763, United States

  • Kailera Clinical Site

    RECRUITING

    Northridge, California, 91325, United States

  • Kailera Clinical Site

    RECRUITING

    Oceanside, California, 92058, United States

  • Kailera Clinical Site

    RECRUITING

    Toluca Lake, California, 91602, United States

  • Kailera Clinical Site

    RECRUITING

    Stamford, Connecticut, 06905, United States

  • Kailera Clinical Site

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Kailera Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Kailera Clinical Site

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Kailera Clinical Site

    RECRUITING

    Miami, Florida, 33135, United States

  • Kailera Clinical Site

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Kailera Clinical Site

    RECRUITING

    Orange City, Florida, 32763, United States

  • Kailera Clinical Site

    RECRUITING

    Orlando, Florida, 32801, United States

  • Kailera Clinical Site

    RECRUITING

    Orlando, Florida, 32803, United States

  • Kailera Clinical Site

    RECRUITING

    The Villages, Florida, 32162, United States

  • Kailera Clinical Site

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Kailera Clinical Site

    RECRUITING

    Lilburn, Georgia, 30047, United States

  • Kailera Clinical Site

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Kailera Clinical Site

    RECRUITING

    Riverdale, Georgia, 30274, United States

  • Kailera Clinical Site

    RECRUITING

    Skokie, Illinois, 60077, United States

  • Kailera Clinical Site

    ACTIVE_NOT_RECRUITING

    Springfield, Illinois, 62702, United States

  • Kailera Clinical Site

    RECRUITING

    Newton, Kansas, 67114, United States

  • Kailera Clinical Site

    RECRUITING

    Shreveport, Louisiana, 71105, United States

  • Kailera Clinical Site

    RECRUITING

    Annapolis, Maryland, 21401, United States

  • Kailera Clinical Site

    RECRUITING

    Columbia, Maryland, 21045, United States

  • Kailera Clinical Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Kailera Clinical Site

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Kailera Clinical Site

    RECRUITING

    Missoula, Montana, 59804, United States

  • Kailera Clinical Site

    RECRUITING

    Lincoln, Nebraska, 68516, United States

  • Kailera Clinical Site

    RECRUITING

    Las Vegas, Nevada, 89148, United States

  • Kailera Clinical Site

    RECRUITING

    Albany, New York, 12203, United States

  • Kailera Clinical Site

    RECRUITING

    Laurelton, New York, 11413, United States

  • Kailera Clinical Site

    RECRUITING

    New York, New York, 10016, United States

  • Kailera Clinical Site

    RECRUITING

    Greensboro, North Carolina, 27405, United States

  • Kailera Clinical Site

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Kailera Clinical Site

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Kailera Clinical Site

    RECRUITING

    Morrisville, North Carolina, 27560, United States

  • Kailera Clinical Site

    RECRUITING

    Cleveland, Ohio, 44122, United States

  • Kailera Clinical Site

    RECRUITING

    Chickasha, Oklahoma, 73018, United States

  • Kailera Clinical Site

    RECRUITING

    East Greenwich, Rhode Island, 02818, United States

  • Kailera Clinical Site

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Kailera Clinical Site

    ACTIVE_NOT_RECRUITING

    Chattanooga, Tennessee, 37405, United States

  • Kailera Clinical Site

    RECRUITING

    Amarillo, Texas, 79124, United States

  • Kailera Clinical Site

    RECRUITING

    Brownsville, Texas, 78526, United States

  • Kailera Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Kailera Clinical Site

    RECRUITING

    El Paso, Texas, 79902, United States

  • Kailera Clinical Site

    RECRUITING

    Farmers Branch, Texas, 75234, United States

  • Kailera Clinical Site

    RECRUITING

    Kingwood, Texas, 77345, United States

  • Kailera Clinical Site

    RECRUITING

    Plano, Texas, 75093, United States

  • Kailera Clinical Site

    RECRUITING

    Tomball, Texas, 77375, United States

  • Kailera Clinical Site

    RECRUITING

    Pleasant View, Utah, 84404, United States

  • Kailera Clinical Site

    RECRUITING

    Salt Lake City, Utah, 84117, United States

  • Kailera Clinical Site

    RECRUITING

    Manassas, Virginia, 20110, United States

  • Kailera Clinical Site

    RECRUITING

    Richmond, Virginia, 23236, United States

  • Kailera Clinical Site

    RECRUITING

    Seattle, Washington, 98104, United States

  • Kailera Clinical Site

    RECRUITING

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1120, Argentina

  • Kailera Clinical Site

    RECRUITING

    La Plata, Buenos Aires, 1900, Argentina

  • Kailera Clinical Site

    RECRUITING

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Kailera Clinical Site

    RECRUITING

    San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina

  • Kailera Clinical Site

    RECRUITING

    Zárate, Buenos Aires, 2800, Argentina

  • Kailera Clinical Site

    RECRUITING

    Godoy Cruz, Mendoza Province, 5501, Argentina

  • Kailera Clinical Site

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Kailera Clinical Site

    RECRUITING

    Rosario, Sante Fe, 2000, Argentina

  • Kailera Clinical Site

    RECRUITING

    Buenos Aires, 1056, Argentina

  • Kailera Clinical Site

    RECRUITING

    Buenos Aires, 1060, Argentina

  • Kailera Clinical Site

    RECRUITING

    Buenos Aires, 1061, Argentina

  • Kailera Clinical Site

    RECRUITING

    Buenos Aires, 1128, Argentina

  • Kailera Clinical Site

    RECRUITING

    Córdoba, 5000, Argentina

  • Kailera Clinical Site

    RECRUITING

    Córdoba, 5002, Argentina

  • Kailera Clinical Site

    RECRUITING

    Bruce, Australian Capital Territory, 2617, Australia

  • Kailera Clinical Site

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • Kailera Clinical Site

    RECRUITING

    Charlestown, New South Wales, 2290, Australia

  • Kailera Clinical Site

    RECRUITING

    Kanwal, New South Wales, 2259, Australia

  • Kailera Clinical Site

    RECRUITING

    Leichhardt, New South Wales, 2040, Australia

  • Kailera Clinical Site

    RECRUITING

    Penrith, New South Wales, 2750, Australia

  • Kailera Clinical Site

    RECRUITING

    Sydney, New South Wales, 2100, Australia

  • Kailera Clinical Site

    RECRUITING

    Sydney, New South Wales, 2228, Australia

  • Kailera Clinical Site

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Kailera Clinical Site

    RECRUITING

    Herston, Queensland, 4006, Australia

  • Kailera Clinical Site

    RECRUITING

    Morayfield, Queensland, 4506, Australia

  • Kailera Clinical Site

    RECRUITING

    Camberwell, Victoria, 3124, Australia

  • Kailera Clinical Site

    RECRUITING

    Melbourne, Victoria, 3025, Australia

  • Kailera Clinical Site

    RECRUITING

    South Brisbane, 4101, Australia

  • Kailera Clinical Site

    RECRUITING

    Kyustendil, Kyustendil Province, 2500, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Pleven, Pleven Province, 5800, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Plovdiv, Plovdiv Province, 4020, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Rousse, Ruse Province, 7013, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, Sofia, 1527, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, Sofia, 1606, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, Sofia, 1618, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Stara Zagora, Stara Zagora Province, 6000, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Varna, Varna Province, 9000, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Montana, 3400, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Brandýs nad Labem, Central Bohemia, 25001, Czechia

  • Kailera Clinical Site

    RECRUITING

    Náchod, Hradec Králové Region, 54701, Czechia

  • Kailera Clinical Site

    RECRUITING

    Trutnov, Hradec Králové Region, 54101, Czechia

  • Kailera Clinical Site

    RECRUITING

    Bohnice, Prague, 18100, Czechia

  • Kailera Clinical Site

    RECRUITING

    Prague, Prague, 14059, Czechia

  • Kailera Clinical Site

    RECRUITING

    Brno, South Moravian, 60200, Czechia

  • Kailera Clinical Site

    RECRUITING

    Holešov, Zlín, 76901, Czechia

  • Kailera Clinical Site

    RECRUITING

    Hodonín, 69501, Czechia

  • Kailera Clinical Site

    RECRUITING

    Olomouc, 77900, Czechia

  • Kailera Clinical Site

    RECRUITING

    Pardubice, 53002, Czechia

  • Kailera Clinical Site

    RECRUITING

    Prague, 15000, Czechia

  • Kailera Clinical Site

    RECRUITING

    Uherské Hradiště, 68601, Czechia

  • Kailera Clinical Site

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Kailera Clinical Site

    RECRUITING

    Falkensee, Brandenburg, 14612, Germany

  • Kailera Clinical Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 51069, Germany

  • Kailera Clinical Site

    RECRUITING

    Essen, North Rhine-Westphalia, 45355, Germany

  • Kailera Clinical Site

    RECRUITING

    Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

  • Kailera Clinical Site

    RECRUITING

    Schwerin, 19055, Germany

  • Kailera Clinical Site

    RECRUITING

    Grafton, Auckland, 1010, New Zealand

  • Kailera Clinical Site

    RECRUITING

    New Lynn, Auckland, 0610, New Zealand

  • Kailera Clinical Site

    RECRUITING

    Silverdale, Auckland, 0932, New Zealand

  • Kailera Clinical Site

    RECRUITING

    Takapuna, Auckland, 0622, New Zealand

  • Kailera Clinical Site

    RECRUITING

    Nawton, Hamilton, 3200, New Zealand

  • Kailera Clinical Site

    RECRUITING

    Auckland, 1023, New Zealand

  • Kailera Clinical Site

    RECRUITING

    Hastings, 4120, New Zealand

  • Kailera Clinical Site

    RECRUITING

    Nelson, 7011, New Zealand

  • Kailera Clinical Site

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231, Poland

  • Kailera Clinical Site

    RECRUITING

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Kailera Clinical Site

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-033, Poland

  • Kailera Clinical Site

    RECRUITING

    Lublin, Lublin Voivodeship, 20-718, Poland

  • Kailera Clinical Site

    RECRUITING

    Siedlce, Masovian Voivodeship, 08-110, Poland

  • Kailera Clinical Site

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-872, Poland

  • Kailera Clinical Site

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-351, Poland

  • Kailera Clinical Site

    RECRUITING

    Gdynia, Pomeranian Voivodeship, 81-338, Poland

  • Kailera Clinical Site

    RECRUITING

    Chorzów, Silesian Voivodeship, 41-500, Poland

  • Kailera Clinical Site

    RECRUITING

    Gdynia, 81-338, Poland

  • Kailera Clinical Site

    RECRUITING

    Krakow, 30-363, Poland

  • Kailera Clinical Site

    RECRUITING

    Warsaw, 02-677, Poland

  • Kailera Clinical Site

    RECRUITING

    Skierniewice, Łódź Voivodeship, 96-100, Poland

  • Kailera Clinical Site

    RECRUITING

    Kielce, Świętokrzyskie Voivodeship, 25-338, Poland

  • Kailera Clinical Site

    RECRUITING

    Bayamón, 00959, Puerto Rico

  • Kailera Clinical Site

    RECRUITING

    Ponce, 00716, Puerto Rico

  • Kailera Clinical Site

    RECRUITING

    San Juan, 00907, Puerto Rico

  • Kailera Clinical Site

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Kailera Clinical Site

    RECRUITING

    Vega Baja, 693, Puerto Rico

  • Kailera Clinical Site

    RECRUITING

    Ferrol, A Coruna, 15402, Spain

  • Kailera Clinical Site

    RECRUITING

    Seville, Andalusia, 41010, Spain

  • Kailera Clinical Site

    RECRUITING

    Villamartín, Cadiz, 11650, Spain

  • Kailera Clinical Site

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

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