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RECRUITING
NCT07284901
PHASE3

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

Sponsor: Kailera

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1700

Start Date

2026-01-12

Completion Date

2028-04-24

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

KAI-9531

SC Injection

DRUG

Placebo

SC Injection

Locations (30)

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

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

Missoula, Montana, United States

Kailera Clinical Site

Las Vegas, Nevada, United States

Kailera Clinical Site

Albany, 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