NCT07497880 · Kailera
Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
What this study is about
The primary objective of this study is to determine the effectiveness of taken by mouth KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. effectiveness in participants with type 2 diabetes mellitus will be evaluated.
View original scientific description
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following:
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea
- Cardiovascular disease
- For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m\^2 only:
- Diagnosis of type 2 diabetes mellitus
- On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening Key
Exclusion criteria
- For participants without diabetes:
- Laboratory evidence of diabetes
- Taking a concomitant medication for the indication of glycemic control
- For participants living with type 2 diabetes mellitus only:
- 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 proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
- Started medications that may cause significant weight change within 3 months prior to screening, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to screening
- 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 clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect 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, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening Note: Additional inclusion/exclusion criteria may apply, per protocol.
Where
- Chandler, Arizona
- Irvine, California
- Lincoln, California
- Northridge, California
- Hamden, Connecticut
- Jacksonville, Florida
- Jupiter, Florida
- Pembroke Pines, Florida
- Decatur, Georgia
- Skokie, Illinois
- South Bend, Indiana
- Kenner, Louisiana
And 10 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations