Actively Recruiting
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
Eligibility Criteria
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
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
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
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4
Kailera Clinical Site
Sun City, Arizona, United States, 85351
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5
Kailera Clinical Site
Escondido, California, United States, 92025
Actively Recruiting
6
Kailera Clinical Site
Toluca Lake, California, United States, 91602
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7
Kailera Clinical Site
Aurora, Colorado, United States, 80012
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8
Kailera Clinical Site
Bridgeport, Connecticut, United States, 06606
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9
Kailera Clinical Site
Jupiter, Florida, United States, 33458
Actively Recruiting
10
Kailera Clinical Site
Lilburn, Georgia, United States, 30047
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11
Kailera Clinical Site
Springfield, Illinois, United States, 62072
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12
Kailera Clinical Site
Columbia, Maryland, United States, 21045
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13
Kailera Clinical Site
Las Vegas, Nevada, United States, 89119
Actively Recruiting
14
Kailera Clinical Site
Rochester, New York, United States, 14609
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15
Kailera Clinical Site
Morehead City, North Carolina, United States, 28557
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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
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19
Kailera Clinical Site
Amarillo, Texas, United States, 79124
Actively Recruiting
20
Kailera Clinical Site
DeSoto, Texas, United States, 75115
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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
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24
Kailera Clinical Site
Silverdale, Auckland, Australia, 0932
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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
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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