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New daily pill aims to shed pounds in obesity trial

NCT ID NCT07497880

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 8 times

Summary

This study tests an experimental oral medication, KAI-7535, taken once daily to help people with obesity or overweight lose weight. About 320 adults with at least one weight-related condition (like high blood pressure or sleep apnea) will receive either the drug or a placebo for 44 weeks. The main goal is to see how much body weight changes from the start of the study.

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

306 people

The number who actually took part.

Started

Apr 2026

Expected to finish

Jul 2027

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 to 75 years

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: * For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following: * Hypertension * Dyslipidemia * Obstructive sleep apnea * Cardiovascular disease * For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m\^2 only: * Diagnosis of type 2 diabetes mellitus * On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening Key Exclusion Criteria: * For participants without diabetes: * Laboratory evidence of diabetes * Taking a concomitant medication for the indication of glycemic control * For participants living with type 2 diabetes mellitus only: * History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening * History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening * History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment * Started medications that may cause significant weight change within 3 months prior to screening, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers * 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 carcinoma * 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 or other severe psychiatric disorder * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 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.

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 Overweight

Contacts and locations

Locations

  • Kailera Clinical Site

    Chandler, Arizona, 85225, United States

  • Kailera Clinical Site

    Phoenix, Arizona, 85044, United States

  • Kailera Clinical Site

    Irvine, California, 92614, United States

  • Kailera Clinical Site

    Lincoln, California, 95648, United States

  • Kailera Clinical Site

    Northridge, California, 91325, United States

  • Kailera Clinical Site

    Hamden, Connecticut, 06517, United States

  • Kailera Clinical Site

    Jacksonville, Florida, 32256, United States

  • Kailera Clinical Site

    Jupiter, Florida, 33458, United States

  • Kailera Clinical Site

    Palm Springs, Florida, 33461, United States

  • Kailera Clinical Site

    Pembroke Pines, Florida, 33024, United States

  • Kailera Clinical Site

    Decatur, Georgia, 30030, United States

  • Kailera Clinical Site

    Chicago, Illinois, 60640, United States

  • Kailera Clinical Site

    Skokie, Illinois, 60077, United States

  • Kailera Clinical Site

    South Bend, Indiana, 46617, United States

  • Kailera Clinical Site

    Kenner, Louisiana, 70065, United States

  • Kailera Clinical Site

    Garden City, Michigan, 48135, United States

  • Kailera Clinical Site

    Jefferson City, Missouri, 65109, United States

  • Kailera Clinical Site

    Kansas City, Missouri, 64151, United States

  • Kailera Clinical Site

    Spartanburg, South Carolina, 29303, United States

  • Kailera Clinical Site

    Knoxville, Tennessee, 37909, United States

  • Kailera Clinical Site

    Austin, Texas, 78705, United States

  • Kailera Clinical Site

    Austin, Texas, 78757, United States

  • Kailera Clinical Site

    Brownsville, Texas, 78520, United States

  • Kailera Clinical Site

    Farmers Branch, Texas, 75234, United States

  • Kailera Clinical Site

    Fort Worth, Texas, 76135, United States

  • Kailera Clinical Site

    Mesquite, Texas, 75149, United States

  • Kailera Clinical Site

    San Antonio, Texas, 78222, United States

  • Kailera Clinical Site

    San Antonio, Texas, 78229, United States

  • Kailera Clinical Site

    San Antonio, Texas, 78240, United States

  • Kailera Clinical Site

    Sugar Land, Texas, 77479, United States

  • Kailera Clinical Site

    Sandy City, Utah, 84093, United States

  • Kailera Clinical Site

    Dee Why, New South Wales, 2100, Australia

  • Kailera Clinical Site

    Miranda, New South Wales, 2228, Australia

  • Kailera Clinical Site

    Wollongong, New South Wales, 2500, Australia

  • Kailera Clinical Site

    Norwood, South Australia, 5067, Australia

  • Kailera Clinical Site

    Altona N., Victoria, 3025, Australia

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