RecruitingPhase 3NCT07284875

Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Sponsor

Kailera

Enrollment

1,800 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Overweight

Summary

The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing an experimental weekly injectable medication called KAI-9531 to see whether it can help people living with obesity or overweight — without diabetes — achieve meaningful weight loss compared to a placebo injection. People with overweight plus at least one weight-related health condition (like high blood pressure, high cholesterol, sleep apnea, or cardiovascular disease) are also eligible. Adults with a BMI of 30 or higher, or 27 or higher with qualifying health conditions, who have tried and failed at least one weight loss attempt with diet and exercise in the past 6 months can participate — those with diabetes, a history of medullary thyroid cancer, or significant psychiatric or cardiovascular conditions are not eligible. Participation involves weekly subcutaneous (under-the-skin) injections and regular clinic visits to monitor weight change and safety. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKAI-9531

SC Injection

DRUGPlacebo

SC Injection

Locations(33)

Kailera Clinical Site

Anniston, Alabama, United States

Kailera Clinical Site

Cullman, Alabama, United States

Kailera Clinical Site

Sun City, Arizona, United States

Kailera Clinical Site

Escondido, California, United States

Kailera Clinical Site

Toluca Lake, California, United States

Kailera Clinical Site

Aurora, Colorado, United States

Kailera Clinical Site

Bridgeport, Connecticut, United States

Kailera Clinical Site

Jupiter, Florida, United States

Kailera Clinical Site

Lilburn, Georgia, United States

Kailera Clinical Site

Springfield, Illinois, United States

Kailera Clinical Site

Columbia, Maryland, United States

Kailera Clinical Site

Las Vegas, Nevada, United States

Kailera Clinical Site

Rochester, New York, United States

Kailera Clinical Site

Morehead City, North Carolina, United States

Kailera Clinical Site

Chickasha, Oklahoma, United States

Kailera Clinical Site

Mauldin, South Carolina, United States

Kailera Clinical Site

Chattanooga, Tennessee, United States

Kailera Clinical Site

Amarillo, Texas, United States

Kailera Clinical Site

DeSoto, Texas, United States

Kailera Clinical Site

Tomball, Texas, United States

Kailera Clinical Site

Salt Lake City, Utah, United States

Kailera Clinical Site

Danville, Virginia, United States

Kailera Clinical Site

Silverdale, Auckland, Australia

Kailera Clinical Site

Sydney, New South Wales, Australia

Kailera Clinical Site

Sydney, New South Wales, Australia

Kailera Clinical Site

Wollongong, New South Wales, Australia

Kailera Clinical Site

Sippy Downs, Queensland, Australia

Kailera Clinical Site

Norwood, South Australia, Australia

Kailera Clinical Site

Melbourne, Victoria, Australia

Kailera Clinical Site

Grafton, Auckland, New Zealand

Kailera Clinical Site

Hamilton, Waikato Region, New Zealand

Kailera Clinical Site

Auckland, New Zealand

Kailera Clinical Site

Nelson, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07284875

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