Efficacy and Safety of KAI-9531 compared with Semaglutide in Participants Living With Obesity Who Do Not Have Diabetes (KaiNETIC-3)

Prior treatment

• Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months prior to Screening.
• Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, phentermine..
• Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.
• Known clinically significant gastric-emptying abnormality (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility.

Other illness

• Current diagnosis or history of diabetes mellitus
• Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
• Uncontrolled hypertension or unstable cardiovascular disease
• History of chronic or acute pancreatitis
• History of suicide attempt.
• History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder

• BMI ≥35 kg/m
• History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.