Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07284875

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

Led by Kailera · Updated on 2026-05-08

1800

Participants Needed

36

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with a body mass index (BMI) of 30 kg/m² or higher
  • Adults with BMI of 27 kg/m² or higher and at least one weight-related condition such as hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
  • History of at least one unsuccessful attempt to lose weight with diet and exercise in the past 6 months
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of diabetes mellitus
  • Started medications within 3 months before screening that may cause significant weight gain, including 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 hypertension or unstable cardiovascular disease
  • History of chronic or acute pancreatitis
  • Known significant gastric-emptying problems or chronic use of medications affecting gastrointestinal movement
  • History of suicide attempt
  • History of active or unstable major depressive disorder or other severe psychiatric disorders
  • Treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 36 locations

1

Kailera Clinical Site

Anniston, Alabama, United States, 36207

Actively Recruiting

2

Kailera Clinical Site

Birmingham, Alabama, United States, 35294

Actively Recruiting

3

Kailera Clinical Site

Cullman, Alabama, United States, 35055

Actively Recruiting

4

Kailera Clinical Site

Sun City, Arizona, United States, 85351

Actively Recruiting

5

Kailera Clinical Site

Escondido, California, United States, 92025

Actively Recruiting

6

Kailera Clinical Site

Toluca Lake, California, United States, 91602

Actively Recruiting

7

Kailera Clinical Site

Aurora, Colorado, United States, 80012

Actively Recruiting

8

Kailera Clinical Site

Bridgeport, Connecticut, United States, 06606

Actively Recruiting

9

Kailera Clinical Site

Jupiter, Florida, United States, 33458

Actively Recruiting

10

Kailera Clinical Site

Lilburn, Georgia, United States, 30047

Actively Recruiting

11

Kailera Clinical Site

Springfield, Illinois, United States, 62072

Actively Recruiting

12

Kailera Clinical Site

Columbia, Maryland, United States, 21045

Actively Recruiting

13

Kailera Clinical Site

Las Vegas, Nevada, United States, 89119

Actively Recruiting

14

Kailera Clinical Site

Rochester, New York, United States, 14609

Actively Recruiting

15

Kailera Clinical Site

Morehead City, North Carolina, United States, 28557

Actively Recruiting

16

Kailera Clinical Site

Chickasha, Oklahoma, United States, 73018

Actively Recruiting

17

Kailera Clinical Site

Mauldin, South Carolina, United States, 29662

Actively Recruiting

18

Kailera Clinical Site

Chattanooga, Tennessee, United States, 37405

Actively Recruiting

19

Kailera Clinical Site

Amarillo, Texas, United States, 79124

Actively Recruiting

20

Kailera Clinical Site

DeSoto, Texas, United States, 75115

Actively Recruiting

21

Kailera Clinical Site

Tomball, Texas, United States, 77375

Actively Recruiting

22

Kailera Clinical Site

Salt Lake City, Utah, United States, 84124

Actively Recruiting

23

Kailera Clinical Site

Danville, Virginia, United States, 24541

Actively Recruiting

24

Kailera Clinical Site

Silverdale, Auckland, Australia, 0932

Actively Recruiting

25

Kailera Clinical Site

Charlestown, New South Wales, Australia, 2290

Actively Recruiting

26

Kailera Clinical Site

Sydney, New South Wales, Australia, 2019

Actively Recruiting

27

Kailera Clinical Site

Sydney, New South Wales, Australia, 2100

Actively Recruiting

28

Kailera Clinical Site

Sydney, New South Wales, Australia, 2228

Actively Recruiting

29

Kailera Clinical Site

Wollongong, New South Wales, Australia, 2500

Actively Recruiting

30

Kailera Clinical Site

Sippy Downs, Queensland, Australia, 4556

Actively Recruiting

31

Kailera Clinical Site

Norwood, South Australia, Australia, 5067

Actively Recruiting

32

Kailera Clinical Site

Melbourne, Victoria, Australia, 3025

Actively Recruiting

33

Kailera Clinical Site

Grafton, Auckland, New Zealand, 1010

Actively Recruiting

34

Kailera Clinical Site

Hamilton, Waikato Region, New Zealand, 3200

Actively Recruiting

35

Kailera Clinical Site

Auckland, New Zealand, 0610

Actively Recruiting

36

Kailera Clinical Site

Nelson, New Zealand, 7011

Actively Recruiting

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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

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