Actively Recruiting
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
Eligibility Criteria
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
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
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
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5
Kailera Clinical Site
Long Beach, California, United States, 90815
Actively Recruiting
6
Kailera Clinical Site
Montclair, California, United States, 91763
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7
Kailera Clinical Site
Rolling Hills Estates, California, United States, 90274
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8
Kailera Clinical Site
San Diego, California, United States, 92103
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9
Kailera Clinical Site
Santa Ana, California, United States, 92704
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10
Kailera Clinical Site
Van Nuys, California, United States, 91405
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11
Kailera Clinical Site
DeLand, Florida, United States, 32720
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12
Kailera Clinical Site
Orlando, Florida, United States, 32801
Actively Recruiting
13
Kailera Clinical Site
Orlando, Florida, United States, 32803
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14
Kailera Clinical Site
The Villages, Florida, United States, 32162
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15
Kailera Clinical Site
Decatur, Georgia, United States, 30030
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16
Kailera Clinical Site
Woodstock, Georgia, United States, 30189
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17
Kailera Clinical Site
Morton, Illinois, United States, 61550
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18
Kailera Clinical Site
Indianapolis, Indiana, United States, 46254
Actively Recruiting
19
Kailera Clinical Site
Louisville, Kentucky, United States, 40213
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20
Kailera Clinical Site
Rockville, Maryland, United States, 20852
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21
Kailera Clinical Site
St Louis, Missouri, United States, 63141
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22
Kailera Clinical Site
Lincoln, Nebraska, United States, 68516
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23
Kailera Clinical Site
Omaha, Nebraska, United States, 68144
Actively Recruiting
24
Kailera Clinical Site
East Syracuse, New York, United States, 13057
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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
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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