Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

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.