What this trial means for you
This study is recruiting now at 28 US sites. It's studying KAI-7535, Placebo for obesity, overweight.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Key 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.
Study sites by state
Arizona
- Kailera Clinical Site, Chandler · Recruiting now
- Kailera Clinical Site, Phoenix · Recruiting now
California
- Kailera Clinical Site, Irvine · Recruiting now
- Kailera Clinical Site, Lincoln · Recruiting now
- Kailera Clinical Site, Northridge · Recruiting now
Connecticut
- Kailera Clinical Site, Hamden · Recruiting now
Florida
- Kailera Clinical Site, Jacksonville · Recruiting now
- Kailera Clinical Site, Jupiter · Recruiting now
- Kailera Clinical Site, Pembroke Pines · Recruiting now
Georgia
- Kailera Clinical Site, Decatur · Recruiting now
Illinois
- Kailera Clinical Site, Skokie · Recruiting now
Indiana
- Kailera Clinical Site, South Bend · Recruiting now
Louisiana
- Kailera Clinical Site, Kenner · Recruiting now
Michigan
- Kailera Clinical Site, Garden City · Recruiting now
Missouri
- Kailera Clinical Site, Jefferson City · Recruiting now
- Kailera Clinical Site, Kansas City · Recruiting now
South Carolina
- Kailera Clinical Site, Spartanburg · Recruiting now
Tennessee
- Kailera Clinical Site, Knoxville · Recruiting now
Texas
- Kailera Clinical Site, Austin · Recruiting now
- Kailera Clinical Site, Austin · Recruiting now
- Kailera Clinical Site, Brownsville · Recruiting now
- Kailera Clinical Site, Farmers Branch · Recruiting now
- Kailera Clinical Site, Mesquite · Recruiting now
- Kailera Clinical Site, San Antonio · Recruiting now
- Kailera Clinical Site, San Antonio · Recruiting now
- Kailera Clinical Site, San Antonio · Recruiting now
- Kailera Clinical Site, Sugar Land · Recruiting now
Utah
- Kailera Clinical Site, Sandy City · Recruiting now
View the official record on ClinicalTrials.gov →
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