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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adults Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Led by Kailera · Updated on 2026-06-05
320
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of oral KAI-7535 taken once daily in adults living with obesity or overweight who have at least one weight-related health condition. The study aims to compare the impact of KAI-7535 with a placebo on body weight changes, especially focusing on participants without diabetes mellitus, while also evaluating those with type 2 diabetes. Safety, tolerability, and other weight-related outcomes will also be assessed in both groups. Participants will be randomly assigned to receive either KAI-7535 or a matching placebo once daily. The study includes multiple dose schedules of KAI-7535 and involves a double-blind setup where neither participants nor researchers know which treatment is given. The trial is conducted at multiple centers and is designed to assess the treatment effects over a 44-week period. During the study, participants' body weight and body mass index (BMI) will be measured at the start and at week 44. Researchers will monitor changes in weight, safety, and tolerability throughout the trial. The main outcome is the percent change in body weight from baseline to week 44, with additional assessments of weight reduction percentages and BMI changes. Participants will be followed closely for the duration of the study, which lasts 44 weeks, to collect all relevant data.
CONDITIONS
Brief Title
Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Without diabetes mellitus: BMI of 30 kg/m² or higher, or BMI of 27 kg/m² or higher with at least one of hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- With type 2 diabetes mellitus: diagnosis of type 2 diabetes and BMI of 27 kg/m² or higher
- On stable therapy for type 2 diabetes for at least 3 months prior to screening
You will not qualify if you...
- Without diabetes: laboratory evidence of diabetes or taking medication for glycemic control
- With type 2 diabetes: history of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
- History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
- History of diabetic retinopathy requiring acute treatment
- Started medications causing significant weight change within 3 months prior to screening (e.g., tricyclic antidepressants, atypical antipsychotics, mood stabilizers)
- Unstable weight with more than 5% change in last 3 months
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma
- Uncontrolled hypertension or unstable cardiovascular disease
- History of chronic or acute pancreatitis
- Known significant gastric-emptying abnormality or treatment affecting gastrointestinal motility
- History of suicide attempt
- History of significant active or unstable major depressive or other severe psychiatric disorder
- Treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 44 weeks
Participants receive oral KAI-7535 or placebo once daily to evaluate effects on body weight and related health measures.
Regular visits during treatment period as determined by the study protocol
Trial Site Locations
Total: 19 locations
1
Kailera Clinical Site
Chandler, Arizona, United States, 85225
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2
Kailera Clinical Site
Irvine, California, United States, 92614
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3
Kailera Clinical Site
Lincoln, California, United States, 95648
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4
Kailera Clinical Site
Northridge, California, United States, 91325
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5
Kailera Clinical Site
Hamden, Connecticut, United States, 06517
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6
Kailera Clinical Site
Jupiter, Florida, United States, 33458
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7
Kailera Clinical Site
Pembroke Pines, Florida, United States, 33024
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8
Kailera Clinical Site
Decatur, Georgia, United States, 30030
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9
Kailera Clinical Site
Skokie, Illinois, United States, 60077
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10
Kailera Clinical Site
South Bend, Indiana, United States, 46617
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11
Kailera Clinical Site
Kenner, Louisiana, United States, 70065
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12
Kailera Clinical Site
Garden City, Michigan, United States, 48135
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13
Kailera Clinical Site
Jefferson City, Missouri, United States, 65109
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14
Kailera Clinical Site
Kansas City, Missouri, United States, 64151
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15
Kailera Clinical Site
Knoxville, Tennessee, United States, 37909
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16
Kailera Clinical Site
Austin, Texas, United States, 78757
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17
Kailera Clinical Site
Brownsville, Texas, United States, 78520
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18
Kailera Clinical Site
Farmers Branch, Texas, United States, 75234
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19
Kailera Clinical Site
San Antonio, Texas, United States, 78229
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Research Team
K
Kailera Therapeutics, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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