Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Recruiting · NCT07497880 · Interventional (participants receive a specific treatment) · Lead sponsor: Kailera
View the official record on ClinicalTrials.gov →Interventions studied
KAI-7535Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
36 locations listed across 14 US states.
- Kailera Clinical Site - Chandler, Arizona, United States
- Kailera Clinical Site - Phoenix, Arizona, United States
- Kailera Clinical Site - Irvine, California, United States
- Kailera Clinical Site - Lincoln, California, United States
- Kailera Clinical Site - Northridge, California, United States
- Kailera Clinical Site - Hamden, Connecticut, United States
- Kailera Clinical Site - Jacksonville, Florida, United States
- Kailera Clinical Site - Jupiter, Florida, United States
- Kailera Clinical Site - Palm Springs, Florida, United States
- Kailera Clinical Site - Pembroke Pines, Florida, United States
- Kailera Clinical Site - Decatur, Georgia, United States
- Kailera Clinical Site - Chicago, Illinois, United States
- Kailera Clinical Site - Skokie, Illinois, United States
- Kailera Clinical Site - South Bend, Indiana, United States
- Kailera Clinical Site - Kenner, Louisiana, United States
- Kailera Clinical Site - Garden City, Michigan, United States
- Kailera Clinical Site - Jefferson City, Missouri, United States
- Kailera Clinical Site - Kansas City, Missouri, United States
- Kailera Clinical Site - Spartanburg, South Carolina, United States
- Kailera Clinical Site - Knoxville, Tennessee, United States
- Kailera Clinical Site - Austin, Texas, United States
- Kailera Clinical Site - Austin, Texas, United States
- Kailera Clinical Site - Brownsville, Texas, United States
- Kailera Clinical Site - Farmers Branch, Texas, United States
- Kailera Clinical Site - Fort Worth, Texas, United States
- Kailera Clinical Site - Mesquite, Texas, United States
- Kailera Clinical Site - San Antonio, Texas, United States
- Kailera Clinical Site - San Antonio, Texas, United States
- Kailera Clinical Site - San Antonio, Texas, United States
- Kailera Clinical Site - Sugar Land, Texas, United States
- Kailera Clinical Site - Sandy City, Utah, United States
- Kailera Clinical Site - Dee Why, New South Wales, Australia
- Kailera Clinical Site - Miranda, New South Wales, Australia
- Kailera Clinical Site - Wollongong, New South Wales, Australia
- Kailera Clinical Site - Norwood, South Australia, Australia
- Kailera Clinical Site - Altona N., Victoria, Australia