Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07458269

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Led by Kailera · Updated on 2026-04-20

250

Participants Needed

33

Research Sites

64 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) 35 kilograms per meter squared (kg/m²) or higher
  • History of at least 1 unsuccessful attempt to lose weight with diet and exercise within the past 6 months
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of diabetes mellitus, including type 1 or type 2 diabetes
  • History of diabetic ketoacidosis or hyperosmolar state/coma
  • Started medications within 3 months before screening that may cause significant weight gain, such as tricyclic antidepressants, atypical antipsychotics, or mood stabilizers
  • Unstable weight with more than 5% change within 3 months before screening
  • Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer
  • Uncontrolled high blood pressure or unstable heart disease
  • History of chronic or acute pancreatitis
  • Known significant gastric-emptying problems or chronic treatment affecting gastrointestinal movement
  • History of suicide attempt
  • History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years before screening
  • Treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, or glucagon receptor agonists within 3 months before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 33 locations

1

Kailera Clinical Site

Mesa, Arizona, United States, 85213

Actively Recruiting

2

Kailera Clinical Site

Sun City West, Arizona, United States, 85375

Actively Recruiting

3

Kailera Clinical Site

Lake Forest, California, United States, 92630

Actively Recruiting

4

Kailera Clinical Site

Lomita, California, United States, 90717

Actively Recruiting

5

Kailera Clinical Site

Long Beach, California, United States, 90815

Actively Recruiting

6

Kailera Clinical Site

Montclair, California, United States, 91763

Actively Recruiting

7

Kailera Clinical Site

Rolling Hills Estates, California, United States, 90274

Actively Recruiting

8

Kailera Clinical Site

San Diego, California, United States, 92103

Actively Recruiting

9

Kailera Clinical Site

Santa Ana, California, United States, 92704

Actively Recruiting

10

Kailera Clinical Site

Van Nuys, California, United States, 91405

Actively Recruiting

11

Kailera Clinical Site

DeLand, Florida, United States, 32720

Actively Recruiting

12

Kailera Clinical Site

Orlando, Florida, United States, 32801

Actively Recruiting

13

Kailera Clinical Site

Orlando, Florida, United States, 32803

Actively Recruiting

14

Kailera Clinical Site

The Villages, Florida, United States, 32162

Actively Recruiting

15

Kailera Clinical Site

Decatur, Georgia, United States, 30030

Actively Recruiting

16

Kailera Clinical Site

Woodstock, Georgia, United States, 30189

Actively Recruiting

17

Kailera Clinical Site

Morton, Illinois, United States, 61550

Actively Recruiting

18

Kailera Clinical Site

Indianapolis, Indiana, United States, 46254

Actively Recruiting

19

Kailera Clinical Site

Louisville, Kentucky, United States, 40213

Actively Recruiting

20

Kailera Clinical Site

Rockville, Maryland, United States, 20852

Actively Recruiting

21

Kailera Clinical Site

St Louis, Missouri, United States, 63141

Actively Recruiting

22

Kailera Clinical Site

Lincoln, Nebraska, United States, 68516

Actively Recruiting

23

Kailera Clinical Site

Omaha, Nebraska, United States, 68144

Actively Recruiting

24

Kailera Clinical Site

East Syracuse, New York, United States, 13057

Actively Recruiting

25

Kailera Clinical Site

Greensboro, North Carolina, United States, 27405

Actively Recruiting

26

Kailera Clinical Site

Monroe, North Carolina, United States, 28112

Actively Recruiting

27

Kailera Clinical Site

Raleigh, North Carolina, United States, 27612

Actively Recruiting

28

Kailera Clinical Site

Greenville, South Carolina, United States, 29607

Actively Recruiting

29

Kailera Clinical Site

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

30

Kailera Clinical Site

Knoxville, Tennessee, United States, 37909

Actively Recruiting

31

Kailera Clinical Site

Memphis, Tennessee, United States, 38119

Actively Recruiting

32

Kailera Clinical Site

San Antonio, Texas, United States, 78215

Actively Recruiting

33

Kailera Clinical Site

Winchester, Virginia, United States, 22601

Actively Recruiting

Loading map...

Research Team

K

Kailera Therapeutics, Inc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here