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

Summary

The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.

Eligibility

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.

Conditions3

Interventions1

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