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New weekly shot could help shed pounds without diabetes

NCT ID NCT07284875

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new weekly injection called KAI-9531 to help people with obesity or overweight lose weight. It is for adults who do not have diabetes but have weight-related health problems like high blood pressure or sleep apnea. About 1800 participants will receive either the drug or a placebo for 76 weeks to see how much weight they lose.

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 2,340 people

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

Started

Dec 2025

Expected to finish

Mar 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.

Inclusion Criteria: * BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following: 1. hypertension, 2. dyslipidemia, 3. obstructive sleep apnea, or 4. cardiovascular (CV) disease. * History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months. Exclusion Criteria: * Current diagnosis or history of diabetes mellitus. * 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 motility. * History of suicide attempt. * History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder. * Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

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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 Overweight

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

    104 sites in 10 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

  • Kailera Clinical Site

    RECRUITING

    Anniston, Alabama, 36207, United States

  • Kailera Clinical Site

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Kailera Clinical Site

    RECRUITING

    Cullman, Alabama, 35055, United States

  • Kailera Clinical Site

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Kailera Clinical Site

    RECRUITING

    Escondido, California, 92025, United States

  • Kailera Clinical Site

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    Toluca Lake, California, 91602, United States

  • Kailera Clinical Site

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Kailera Clinical Site

    RECRUITING

    Bridgeport, Connecticut, 06606, United States

  • Kailera Clinical Site

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    Jupiter, Florida, 33458, United States

  • Kailera Clinical Site

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    Lilburn, Georgia, 30047, United States

  • Kailera Clinical Site

    RECRUITING

    Springfield, Illinois, 62072, United States

  • Kailera Clinical Site

    RECRUITING

    Columbia, Maryland, 21045, United States

  • Kailera Clinical Site

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    Las Vegas, Nevada, 89119, United States

  • Kailera Clinical Site

    RECRUITING

    Rochester, New York, 14609, United States

  • Kailera Clinical Site

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Kailera Clinical Site

    RECRUITING

    Chickasha, Oklahoma, 73018, United States

  • Kailera Clinical Site

    RECRUITING

    Mauldin, South Carolina, 29662, United States

  • Kailera Clinical Site

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    Chattanooga, Tennessee, 37405, United States

  • Kailera Clinical Site

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    Amarillo, Texas, 79124, United States

  • Kailera Clinical Site

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Kailera Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Kailera Clinical Site

    RECRUITING

    Tomball, Texas, 77375, United States

  • Kailera Clinical Site

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    Salt Lake City, Utah, 84124, United States

  • Kailera Clinical Site

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    Danville, Virginia, 24541, United States

  • Kailera Clinical Site

    RECRUITING

    La Plata, Buenos Aires, 1900, Argentina

  • Kailera Clinical Site

    RECRUITING

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

  • Kailera Clinical Site

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1056, Argentina

  • Kailera Clinical Site

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1060, Argentina

  • Kailera Clinical Site

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1120, Argentina

  • Kailera Clinical Site

    RECRUITING

    Godoy Cruz, Mendoza Province, 5501, Argentina

  • Kailera Clinical Site

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Kailera Clinical Site

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    CABA, 1061, Argentina

  • Kailera Clinical Site

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    Córdoba, 5000, Argentina

  • Kailera Clinical Site

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    Charlestown, New South Wales, 2290, Australia

  • Kailera Clinical Site

    RECRUITING

    Sydney, New South Wales, 2019, Australia

  • Kailera Clinical Site

    RECRUITING

    Sydney, New South Wales, 2100, Australia

  • Kailera Clinical Site

    RECRUITING

    Sydney, New South Wales, 2228, Australia

  • Kailera Clinical Site

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    Wollongong, New South Wales, 2500, Australia

  • Kailera Clinical Site

    RECRUITING

    Sippy Downs, Queensland, 4556, Australia

  • Kailera Clinical Site

    RECRUITING

    Norwood, South Australia, 5067, Australia

  • Kailera Clinical Site

    RECRUITING

    Heidelberg Heights, Victoria, 3081, Australia

  • Kailera Clinical Site

    RECRUITING

    Melbourne, Victoria, 3025, Australia

  • Kailera Clinical Site

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    Kyustendil, Kyustendil Province, 2500, Bulgaria

  • Kailera Clinical Site

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    Pazardzhik, 4400, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Plovdiv, 4000, Bulgaria

  • Kailera Clinical Site

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    Plovdiv, 4020, Bulgaria

  • Kailera Clinical Site

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    Sofia, 1431, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, 1510, Bulgaria

  • Kailera Clinical Site

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    Sofia, 1527, Bulgaria

  • Kailera Clinical Site

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    Varna, 9020, Bulgaria

  • Kailera Clinical Site

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    Yambol, 8600, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Brandýs nad Labem, Central Bohemia, 25001, Czechia

  • Kailera Clinical Site

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    Náchod, Hradec Králové Region, 54701, Czechia

  • Kailera Clinical Site

    RECRUITING

    Krnov, Moravian-Silesian Region, 79401, Czechia

  • Kailera Clinical Site

    RECRUITING

    Bohnice, Prague, 18100, Czechia

  • Kailera Clinical Site

    RECRUITING

    Prague, Prague, 12808, Czechia

  • Kailera Clinical Site

    RECRUITING

    Prague, Prague, 14059, Czechia

  • Kailera Clinical Site

    RECRUITING

    Brno, South Moravian, 61500, Czechia

  • Kailera Clinical Site

    RECRUITING

    Hodonín, 69501, Czechia

  • Kailera Clinical Site

    RECRUITING

    Olomouc, 77900, 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

    Dresden, Saxony, 01069, Germany

  • Kailera Clinical Site

    RECRUITING

    Leipzig, Saxony, 04107, Germany

  • Kailera Clinical Site

    RECRUITING

    Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

  • Kailera Clinical Site

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    Hamburg, 22415, Germany

  • Kailera Clinical Site

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    Hamburg, 22607, Germany

  • Kailera Clinical Site

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    Schwerin, 19055, Germany

  • Kailera Clinical Site

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    Grafton, Auckland, 1010, New Zealand

  • Kailera Clinical Site

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    Silverdale, Auckland, 0932, New Zealand

  • Kailera Clinical Site

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    Hamilton, Waikato Region, 3200, New Zealand

  • Kailera Clinical Site

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    Auckland, 0610, New Zealand

  • Kailera Clinical Site

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    Nelson, 7011, New Zealand

  • Kailera Clinical Site

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    Poznan, Greater Poland Voivodeship, 60-589, Poland

  • Kailera Clinical Site

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

  • Kailera Clinical Site

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-363, 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

    Skierniewice, 96-100, Poland

  • Kailera Clinical Site

    RECRUITING

    Zamość, 22-400, Poland

  • 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

  • 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

    Barcelona, 08023, Spain

  • Kailera Clinical Site

    RECRUITING

    Madrid, 28003, Spain

  • Kailera Clinical Site

    RECRUITING

    Valencia, 46014, Spain

  • Kailera Clinical Site

    RECRUITING

    Soham, Cambridgeshire, CB7 5JD, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Torpoint, Cornwall, PL11 2TB, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Hull, East Yorkshire, HU3 2JZ, 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

    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

    Hounslow, TW4 7NJ, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    London, EC1M 6BQ, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Manchester, M13 9WL, United Kingdom

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