Obesity
Conditions
Keywords
Obesity, KAI-9531, Glucagon-like peptide-1, GLP-1, Glucose-dependent Insulinotropic Peptide, GIP, Obesity Without Diabetes
Brief summary
The primary objective of this study is to determine the effects of KAI-9531 administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Interventions
DRUGKAI-9531
SC Injection
DRUGPlacebo
SC Injection
Sponsors
Kailera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * BMI ≥35 kilograms per meter squared (kg/m\^2). * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. Key
Exclusion criteria
* Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma. * Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, 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 cancer. * 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 (MDD) or other severe psychiatric disorder within 2 years prior to Screening. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Body Weight at Week 48 | Baseline, Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight | Baseline, Week 48 |
| Change From Baseline in Waist Circumference | Baseline, Week 48 |
| Change From Baseline in Absolute Body Weight | Baseline, Week 48 |
| Change From Baseline in Body Mass Index (BMI) | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Triglycerides | Baseline, Week 48 |
| Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Non-HDL-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Total Cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Insulin | Baseline, Week 48 |
| Change From Baseline in Fasting Blood Glucose | Baseline, Week 48 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Week 52 |
| Number of Participants With Anti-drug Antibodies (ADAs) | Day 1 up to Week 52 |
| Number of Participants With Neutralizing Antibodies (NAbs) | Day 1 up to Week 52 |
| Plasma Concentrations of KAI-9531 | Day 1 up to Week 52 |
Countries
United States
Contacts
CONTACTKailera Therapeutics, Inc.
Outcome results
None listed