Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Inclusion Criteria:

• BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of thefollowing:

1. hypertension,

2. dyslipidemia,

3. obstructive sleep apnea, or

4. cardiovascular (CV) disease.

• History of at least 1 self-reported unsuccessful effort to lose weight with diet andexercise within the prior 6 months.

Exclusion Criteria:

• Current diagnosis or history of diabetes mellitus.

• Started medications within 3 months prior to Screening that may cause significantweight gain, including, but not limited to, tricyclic antidepressants, atypicalantipsychotics, and mood stabilizers.

• 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 cancer.

• 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 (MDD) or othersevere psychiatric disorder.

• Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist,GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptoragonist within 3 months prior to Screening.

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