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

NCT07497880

RecruitingPhase 2

Sponsor: Kailera

Conditions: Obesity, Overweight

Interventions: KAI-7535, Placebo

Countries: United States, Australia

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (36)

Chandler, Arizona, United States
Phoenix, Arizona, United States
Irvine, California, United States
Lincoln, California, United States
Northridge, California, United States
Hamden, Connecticut, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Palm Springs, Florida, United States
Pembroke Pines, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
South Bend, Indiana, United States
Kenner, Louisiana, United States
Garden City, Michigan, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Spartanburg, South Carolina, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Brownsville, Texas, United States
Farmers Branch, Texas, United States
Fort Worth, Texas, United States
Mesquite, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
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