RecruitingPhase 3NCT07284901

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and 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 and Diabetes


Sponsor

Kailera

Enrollment

1,700 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KAI-9531 and a drug called Placebo for people with obesity with diabetes and overweight with diabetes. The study is currently recruiting participants at 52 locations.

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(52)

Kailera Clinical Site

Cullman, Alabama, United States

Kailera Clinical Site

Phoenix, Arizona, United States

Kailera Clinical Site

Sun City, Arizona, United States

Kailera Clinical Site

Little Rock, Arkansas, United States

Kailera Clinical Site

Escondido, California, United States

Kailera Clinical Site

Northridge, California, United States

Kailera Clinical Site

Oceanside, California, United States

Kailera Clinical Site

Toluca Lake, California, United States

Kailera Clinical Site

Stamford, Connecticut, United States

Kailera Clinical Site

Jupiter, Florida, United States

Kailera Clinical Site

Orange City, Florida, United States

Kailera Clinical Site

Lilburn, Georgia, United States

Kailera Clinical Site

Skokie, Illinois, United States

Kailera Clinical Site

Springfield, Illinois, United States

Kailera Clinical Site

Newton, Kansas, United States

Kailera Clinical Site

Shreveport, Louisiana, United States

Kailera Clinical Site

Columbia, Maryland, United States

Kailera Clinical Site

Farmington Hills, Michigan, United States

Kailera Clinical Site

Missoula, Montana, United States

Kailera Clinical Site

Lincoln, Nebraska, United States

Kailera Clinical Site

Las Vegas, Nevada, United States

Kailera Clinical Site

Albany, New York, United States

Kailera Clinical Site

Laurelton, New York, United States

Kailera Clinical Site

Greensboro, North Carolina, United States

Kailera Clinical Site

Morehead City, North Carolina, United States

Kailera Clinical Site

Chickasha, Oklahoma, United States

Kailera Clinical Site

Spartanburg, South Carolina, United States

Kailera Clinical Site

Chattanooga, Tennessee, United States

Kailera Clinical Site

Amarillo, Texas, United States

Kailera Clinical Site

Brownsville, 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

Richmond, Virginia, United States

Kailera Clinical Site

Bruce, Australian Capital Territory, Australia

Kailera Clinical Site

Blacktown, New South Wales, Australia

Kailera Clinical Site

Kanwal, New South Wales, Australia

Kailera Clinical Site

Leichhardt, New South Wales, 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

Herston, Queensland, Australia

Kailera Clinical Site

Camberwell, Victoria, Australia

Kailera Clinical Site

Melbourne, Victoria, Australia

Kailera Clinical Site

Grafton, Auckland, New Zealand

Kailera Clinical Site

New Lynn, Auckland, New Zealand

Kailera Clinical Site

Silverdale, Auckland, New Zealand

Kailera Clinical Site

Takapuna, Auckland, New Zealand

Kailera Clinical Site

Nawton, Hamilton, New Zealand

Kailera Clinical Site

Auckland, New Zealand

Kailera Clinical Site

Hastings, New Zealand

Kailera Clinical Site

Nelson, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07284901