Actively Recruiting
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Led by Kailera · Updated on 2026-04-30
1200
Participants Needed
32
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
CONDITIONS
Official Title
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI 35 kilograms per square meter or higher
- History of at least 1 unsuccessful attempt to lose weight with diet and exercise within the prior 6 months
You will not qualify if you...
- Current diagnosis or history of diabetes mellitus
- Started medications within 3 months prior to Screening that may cause significant weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
- Unstable weight with a change exceeding 5% in the 3 months prior to 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 clinically significant gastric-emptying abnormality or chronic treatment with medications affecting gastrointestinal motility
- History of suicide attempt
- History of significant active or unstable Major Depressive Disorder or other severe psychiatric disorder
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/GIP, or glucagon receptor agonists within 3 months prior to Screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Kailera Clinical Site
Glendale, Arizona, United States, 85308
Actively Recruiting
2
Kailera Clinical Site
Phoenix, Arizona, United States, 85012
Actively Recruiting
3
Kailera Clinical Site
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Kailera Clinical Site
Northridge, California, United States, 91325
Actively Recruiting
5
Kailera Clinical Site
Oceanside, California, United States, 92058
Actively Recruiting
6
Kailera Clinical Site
Hamden, Connecticut, United States, 06517
Actively Recruiting
7
Kailera Clinical Site
Stamford, Connecticut, United States, 06905
Actively Recruiting
8
Kailera Clinical Site
Orange City, Florida, United States, 32763
Actively Recruiting
9
Kailera Clinical Site
Albany, Georgia, United States, 31707
Actively Recruiting
10
Kailera Clinical Site
Chicago, Illinois, United States, 60640
Actively Recruiting
11
Kailera Clinical Site
Newton, Kansas, United States, 67114
Actively Recruiting
12
Kailera Clinical Site
Shreveport, Louisiana, United States, 71105
Actively Recruiting
13
Kailera Clinical Site
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
14
Kailera Clinical Site
Missoula, Montana, United States, 59804
Actively Recruiting
15
Kailera Clinical Site
Las Vegas, Nevada, United States, 89148
Actively Recruiting
16
Kailera Clinical Site
Albany, New York, United States, 12203
Actively Recruiting
17
Kailera Clinical Site
Morehead City, North Carolina, United States, 28557
Actively Recruiting
18
Kailera Clinical Site
Norman, Oklahoma, United States, 73069
Actively Recruiting
19
Kailera Clinical Site
East Greenwich, Rhode Island, United States, 02818
Actively Recruiting
20
Kailera Clinical Site
North Charleston, South Carolina, United States, 29405
Actively Recruiting
21
Kailera Clinical Site
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
22
Kailera Clinical Site
Brownsville, Texas, United States, 78526
Actively Recruiting
23
Kailera Clinical Site
San Antonio, Texas, United States, 78229
Actively Recruiting
24
Kailera Clinical Site
Manassas, Virginia, United States, 20110
Actively Recruiting
25
Kailera Clinical Site
Richmond, Virginia, United States, 23236
Actively Recruiting
26
Kailera Clinical Site
Bruce, Australian Capital Territory, Australia, 2617
Actively Recruiting
27
Kailera Clinical Site
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
28
Kailera Clinical Site
Kanwal, New South Wales, Australia, 2259
Actively Recruiting
29
Kailera Clinical Site
Herston, Queensland, Australia, 4006
Actively Recruiting
30
Kailera Clinical Site
Morayfield, Queensland, Australia, 4506
Actively Recruiting
31
Kailera Clinical Site
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
32
Kailera Clinical Site
Camberwell, Victoria, Australia, 3124
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
4
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