Actively Recruiting
Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Led by Kailera · Updated on 2026-05-12
1700
Participants Needed
46
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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)
CONDITIONS
Official Title
Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Receiving stable therapy for T2DM for at least 3 months before screening, including diet/exercise or oral medications except GLP-1R agonists, GLP-1R/GIPR dual agonists, or DPP-4 inhibitors
- Body mass index (BMI) of 27 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 type 1 diabetes mellitus or other diabetes types besides T2DM
- History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year before screening
- History of severe hypoglycemia or hypoglycemia unawareness within 1 year before screening
- Started medications causing significant weight gain within 3 months before screening, 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 abnormality or chronic use of medications affecting gastrointestinal motility for more than 30 days within 3 months before screening
- History of suicide attempt
- History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years before screening
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/GIP agonists, glucagon receptor agonists, or other weight loss medications or treatments besides diet and exercise within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
Kailera Clinical Site
Cullman, Alabama, United States, 35055
Actively Recruiting
2
Kailera Clinical Site
Phoenix, Arizona, United States, 85012
Actively Recruiting
3
Kailera Clinical Site
Sun City, Arizona, United States, 85351
Actively Recruiting
4
Kailera Clinical Site
Little Rock, Arkansas, United States, 72205
Actively Recruiting
5
Kailera Clinical Site
Escondido, California, United States, 92025
Actively Recruiting
6
Kailera Clinical Site
Northridge, California, United States, 91325
Actively Recruiting
7
Kailera Clinical Site
Oceanside, California, United States, 92058
Actively Recruiting
8
Kailera Clinical Site
Toluca Lake, California, United States, 91602
Actively Recruiting
9
Kailera Clinical Site
Stamford, Connecticut, United States, 06905
Actively Recruiting
10
Kailera Clinical Site
Jupiter, Florida, United States, 33458
Actively Recruiting
11
Kailera Clinical Site
Orange City, Florida, United States, 32763
Actively Recruiting
12
Kailera Clinical Site
Lilburn, Georgia, United States, 30047
Actively Recruiting
13
Kailera Clinical Site
Springfield, Illinois, United States, 62702
Actively Recruiting
14
Kailera Clinical Site
Newton, Kansas, United States, 67114
Actively Recruiting
15
Kailera Clinical Site
Shreveport, Louisiana, United States, 71105
Actively Recruiting
16
Kailera Clinical Site
Columbia, Maryland, United States, 21045
Actively Recruiting
17
Kailera Clinical Site
Missoula, Montana, United States, 59804
Actively Recruiting
18
Kailera Clinical Site
Lincoln, Nebraska, United States, 68516
Actively Recruiting
19
Kailera Clinical Site
Las Vegas, Nevada, United States, 89148
Actively Recruiting
20
Kailera Clinical Site
Albany, New York, United States, 12203
Actively Recruiting
21
Kailera Clinical Site
Greensboro, North Carolina, United States, 27405
Actively Recruiting
22
Kailera Clinical Site
Morehead City, North Carolina, United States, 28557
Actively Recruiting
23
Kailera Clinical Site
Chickasha, Oklahoma, United States, 73018
Actively Recruiting
24
Kailera Clinical Site
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
25
Kailera Clinical Site
Chattanooga, Tennessee, United States, 37405
Active, Not Recruiting
26
Kailera Clinical Site
Amarillo, Texas, United States, 79124
Actively Recruiting
27
Kailera Clinical Site
Brownsville, Texas, United States, 78526
Actively Recruiting
28
Kailera Clinical Site
DeSoto, Texas, United States, 75115
Actively Recruiting
29
Kailera Clinical Site
Tomball, Texas, United States, 77375
Actively Recruiting
30
Kailera Clinical Site
Salt Lake City, Utah, United States, 84117
Actively Recruiting
31
Kailera Clinical Site
Richmond, Virginia, United States, 23236
Actively Recruiting
32
Kailera Clinical Site
Bruce, Australian Capital Territory, Australia, 2617
Actively Recruiting
33
Kailera Clinical Site
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
34
Kailera Clinical Site
Kanwal, New South Wales, Australia, 2259
Actively Recruiting
35
Kailera Clinical Site
Sydney, New South Wales, Australia, 2100
Actively Recruiting
36
Kailera Clinical Site
Sydney, New South Wales, Australia, 2228
Actively Recruiting
37
Kailera Clinical Site
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
38
Kailera Clinical Site
Camberwell, Victoria, Australia, 3124
Actively Recruiting
39
Kailera Clinical Site
Melbourne, Victoria, Australia, 3025
Actively Recruiting
40
Kailera Clinical Site
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
41
Kailera Clinical Site
New Lynn, Auckland, New Zealand, 0610
Actively Recruiting
42
Kailera Clinical Site
Silverdale, Auckland, New Zealand, 0932
Actively Recruiting
43
Kailera Clinical Site
Takapuna, Auckland, New Zealand, 0622
Actively Recruiting
44
Kailera Clinical Site
Nawton, Hamilton, New Zealand, 3200
Actively Recruiting
45
Kailera Clinical Site
Hastings, New Zealand, 4120
Actively Recruiting
46
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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