Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight and Diabetes (KaiNETIC-2)

Prior treatment

• History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within 2 years prior to Screening.
• History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
• History of severe hypoglycemia or hypoglycemia unawareness within 1 year 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, or phentermine.
• Unstable weight defined as self-reported change in body weight exceeding 5% within 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 if taken for >30 days continually within 3 months prior to Screening.

Other illness

• Current diagnosis or history of T1DM or any other type of diabetes except T2DM.
• History of suicide attempt.
• 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.

Lab values

• Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP‑1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.

• Diagnosis of T2DM
• Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucosedependent insulinotropic polypeptide receptor (GIPR) dual agonist, or DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
• BMI ≥27 kg/m2
• History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.