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 ≥30kilograms/square meter (kg/m^2) or BMI ≥27 kg/m^2 and a previous diagnosis of atleast 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 toscreening

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 ofscreening

• History of severe hypoglycemia or hypoglycemia unawareness within 1 year ofscreening

• History of proliferative diabetic retinopathy, diabetic maculopathy, ornonproliferative diabetic retinopathy that required acute treatment

• Started medications that may cause significant weight change within 3 months priorto screening, including tricyclic antidepressants, atypical antipsychotics, and moodstabilizers

• Unstable weight defined as self-reported change in body weight exceeding 5% within 3months prior to screening

• Family or personal history of multiple endocrine neoplasia Type 2 or medullarythyroid carcinoma

• Uncontrolled hypertension or unstable cardiovascular disease

• History of chronic or acute pancreatitis

• Known clinically significant gastric-emptying abnormality or chronic treatment withmedications that directly affect gastrointestinal motility

• History of suicide attempt

• History of significant active or unstable major depressive disorder or other severepsychiatric disorder

• Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1)receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptoragonist, or glucagon receptor agonist within the last 3 months prior to screening

Note: Additional inclusion/exclusion criteria may apply, per protocol.