Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, Glucagon-like peptide-1, GLP-1, KAI-7535, Diabetes, Oral
Brief 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. Safety and tolerability and other weight-related outcomes will also be evaluated.
Interventions
DRUGKAI-7535
Oral tablets
DRUGPlacebo
Oral tablets
Sponsors
Kailera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus | Baseline, Week 44 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Body Weight at Week 44 | Baseline, Week 44 |
| Change from Baseline in Body Mass Index (BMI) at Week 44 | Baseline, Week 44 |
| Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight | Week 44 |
| Change from Baseline in Waist Circumference at Week 44 | Baseline, Week 44 |
Countries
Australia, United States
Outcome results
None listed