New obesity drug aims to beat semaglutide in major trial

NCT ID NCT07284979

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Updated 4 times

Summary

This study tests a new weekly injection called KAI-9531 to help people with obesity lose weight. It involves 1,200 adults who do not have diabetes and compares KAI-9531 to semaglutide (a known weight-loss drug) and a placebo. The main goal is to see how much weight participants lose over 76 weeks.

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 1,200 people

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

Started

Dec 2025

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: * BMI ≥35 kilograms per square meter (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 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, and phentermine. * Unstable weight defined as self-reported change in body weight exceeding 5% within the 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, glucagon-like peptide-1 receptor (GLP-1R) 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.

As listed by the trial registrant

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

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

    59 sites in 5 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

    Glendale, Arizona, 85308, United States

  • Kailera Clinical Site

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Kailera Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Kailera Clinical Site

    RECRUITING

    Northridge, California, 91325, United States

  • Kailera Clinical Site

    RECRUITING

    Oceanside, California, 92058, United States

  • Kailera Clinical Site

    RECRUITING

    Hamden, Connecticut, 06517, United States

  • Kailera Clinical Site

    RECRUITING

    Stamford, Connecticut, 06905, United States

  • Kailera Clinical Site

    RECRUITING

    Orange City, Florida, 32763, United States

  • Kailera Clinical Site

    RECRUITING

    Albany, Georgia, 31707, United States

  • Kailera Clinical Site

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Kailera Clinical Site

    RECRUITING

    Skokie, Illinois, 60077, United States

  • Kailera Clinical Site

    RECRUITING

    Newton, Kansas, 67114, United States

  • Kailera Clinical Site

    RECRUITING

    Shreveport, Louisiana, 71105, 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

    Las Vegas, Nevada, 89148, United States

  • Kailera Clinical Site

    RECRUITING

    Albany, New York, 12203, 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

    Norman, Oklahoma, 73069, United States

  • Kailera Clinical Site

    RECRUITING

    East Greenwich, Rhode Island, 02818, United States

  • Kailera Clinical Site

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Kailera Clinical Site

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Kailera Clinical Site

    RECRUITING

    Brownsville, Texas, 78526, United States

  • Kailera Clinical Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Kailera Clinical Site

    RECRUITING

    Manassas, Virginia, 20110, United States

  • Kailera Clinical Site

    RECRUITING

    Richmond, Virginia, 23236, United States

  • Kailera Clinical Site

    RECRUITING

    Bruce, Australian Capital Territory, 2617, Australia

  • Kailera Clinical Site

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • Kailera Clinical Site

    RECRUITING

    Kanwal, New South Wales, 2259, Australia

  • Kailera Clinical Site

    RECRUITING

    Herston, Queensland, 4006, Australia

  • Kailera Clinical Site

    RECRUITING

    Morayfield, Queensland, 4506, Australia

  • Kailera Clinical Site

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Kailera Clinical Site

    RECRUITING

    Camberwell, Victoria, 3124, Australia

  • Kailera Clinical Site

    RECRUITING

    Pleven, Pleven Province, 5800, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Plovdiv, Plovdiv Province, 4000, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, Sofia, 1606, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, Sofia, 1618, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Varna, Varna Province, 9000, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Montana, 3400, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, 1606, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Sofia, 1616, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Stara Zagora, 6000, Bulgaria

  • Kailera Clinical Site

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-033, Poland

  • Kailera Clinical Site

    RECRUITING

    Warsaw, Masovian Voivodeship, 01-696, Poland

  • Kailera Clinical Site

    RECRUITING

    Gdynia, Pomeranian Voivodeship, 81-384, Poland

  • Kailera Clinical Site

    RECRUITING

    Chorzów, Silesian Voivodeship, 41-500, Poland

  • Kailera Clinical Site

    RECRUITING

    Bydgoszcz, 85-231, Poland

  • Kailera Clinical Site

    RECRUITING

    Gdynia, 81-338, Poland

  • Kailera Clinical Site

    RECRUITING

    Wroclaw, 51-162, Poland

  • Kailera Clinical Site

    RECRUITING

    Kielce, Świętokrzyskie Voivodeship, 25-338, Poland

  • Kailera Clinical Site

    RECRUITING

    Exeter, Devon, EX2 5DW, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Torquay, Devon, TQ2 7AA, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Weymouth, Dorset, DT4 0QE, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Glasgow, Glasgow City, G51 4TF, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    London, Greater London, SE1 9RT, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    London, Greater London, SW1P 2PF, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Kailera Clinical Site

    RECRUITING

    Rotherham, South Yorkshire, S65 1DA, United Kingdom

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