New obesity drug aims to beat semaglutide in major trial
NCT ID NCT07284979
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
59 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Kailera Clinical Site
RECRUITINGGlendale, Arizona, 85308, United States
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Kailera Clinical Site
RECRUITINGPhoenix, Arizona, 85012, United States
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Kailera Clinical Site
RECRUITINGLittle Rock, Arkansas, 72205, United States
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Kailera Clinical Site
RECRUITINGNorthridge, California, 91325, United States
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Kailera Clinical Site
RECRUITINGOceanside, California, 92058, United States
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Kailera Clinical Site
RECRUITINGHamden, Connecticut, 06517, United States
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Kailera Clinical Site
RECRUITINGStamford, Connecticut, 06905, United States
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Kailera Clinical Site
RECRUITINGOrange City, Florida, 32763, United States
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Kailera Clinical Site
RECRUITINGAlbany, Georgia, 31707, United States
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Kailera Clinical Site
RECRUITINGChicago, Illinois, 60640, United States
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Kailera Clinical Site
RECRUITINGSkokie, Illinois, 60077, United States
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Kailera Clinical Site
RECRUITINGNewton, Kansas, 67114, United States
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Kailera Clinical Site
RECRUITINGShreveport, Louisiana, 71105, United States
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Kailera Clinical Site
RECRUITINGFarmington Hills, Michigan, 48334, United States
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Kailera Clinical Site
RECRUITINGMissoula, Montana, 59804, United States
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Kailera Clinical Site
RECRUITINGLas Vegas, Nevada, 89148, United States
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Kailera Clinical Site
RECRUITINGAlbany, New York, 12203, United States
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Kailera Clinical Site
RECRUITINGMorehead City, North Carolina, 28557, United States
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Kailera Clinical Site
RECRUITINGMorrisville, North Carolina, 27560, United States
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Kailera Clinical Site
RECRUITINGNorman, Oklahoma, 73069, United States
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Kailera Clinical Site
RECRUITINGEast Greenwich, Rhode Island, 02818, United States
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Kailera Clinical Site
RECRUITINGNorth Charleston, South Carolina, 29405, United States
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Kailera Clinical Site
RECRUITINGSpartanburg, South Carolina, 29303, United States
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Kailera Clinical Site
RECRUITINGBrownsville, Texas, 78526, United States
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Kailera Clinical Site
RECRUITINGSan Antonio, Texas, 78229, United States
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Kailera Clinical Site
RECRUITINGManassas, Virginia, 20110, United States
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Kailera Clinical Site
RECRUITINGRichmond, Virginia, 23236, United States
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Kailera Clinical Site
RECRUITINGBruce, Australian Capital Territory, 2617, Australia
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Kailera Clinical Site
RECRUITINGBlacktown, New South Wales, 2148, Australia
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Kailera Clinical Site
RECRUITINGKanwal, New South Wales, 2259, Australia
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Kailera Clinical Site
RECRUITINGHerston, Queensland, 4006, Australia
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Kailera Clinical Site
RECRUITINGMorayfield, Queensland, 4506, Australia
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Kailera Clinical Site
RECRUITINGSouth Brisbane, Queensland, 4101, Australia
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Kailera Clinical Site
RECRUITINGCamberwell, Victoria, 3124, Australia
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Kailera Clinical Site
RECRUITINGPleven, Pleven Province, 5800, Bulgaria
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Kailera Clinical Site
RECRUITINGPlovdiv, Plovdiv Province, 4000, Bulgaria
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Kailera Clinical Site
RECRUITINGSofia, Sofia, 1606, Bulgaria
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Kailera Clinical Site
RECRUITINGSofia, Sofia, 1618, Bulgaria
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Kailera Clinical Site
RECRUITINGVarna, Varna Province, 9000, Bulgaria
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Kailera Clinical Site
RECRUITINGMontana, 3400, Bulgaria
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Kailera Clinical Site
RECRUITINGSofia, 1606, Bulgaria
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Kailera Clinical Site
RECRUITINGSofia, 1616, Bulgaria
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Kailera Clinical Site
RECRUITINGStara Zagora, 6000, Bulgaria
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Kailera Clinical Site
RECRUITINGKrakow, Lesser Poland Voivodeship, 30-033, Poland
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Kailera Clinical Site
RECRUITINGWarsaw, Masovian Voivodeship, 01-696, Poland
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Kailera Clinical Site
RECRUITINGGdynia, Pomeranian Voivodeship, 81-384, Poland
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Kailera Clinical Site
RECRUITINGChorzów, Silesian Voivodeship, 41-500, Poland
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Kailera Clinical Site
RECRUITINGBydgoszcz, 85-231, Poland
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Kailera Clinical Site
RECRUITINGGdynia, 81-338, Poland
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Kailera Clinical Site
RECRUITINGWroclaw, 51-162, Poland
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Kailera Clinical Site
RECRUITINGKielce, Świętokrzyskie Voivodeship, 25-338, Poland
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Kailera Clinical Site
RECRUITINGExeter, Devon, EX2 5DW, United Kingdom
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Kailera Clinical Site
RECRUITINGTorquay, Devon, TQ2 7AA, United Kingdom
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Kailera Clinical Site
RECRUITINGWeymouth, Dorset, DT4 0QE, United Kingdom
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Kailera Clinical Site
RECRUITINGGlasgow, Glasgow City, G51 4TF, United Kingdom
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Kailera Clinical Site
RECRUITINGLondon, Greater London, SE1 9RT, United Kingdom
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Kailera Clinical Site
RECRUITINGLondon, Greater London, SW1P 2PF, United Kingdom
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Kailera Clinical Site
RECRUITINGLeicester, Leicestershire, LE5 4PW, United Kingdom
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Kailera Clinical Site
RECRUITINGRotherham, South Yorkshire, S65 1DA, United Kingdom
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