Obesity
Conditions
Keywords
Obesity, KAI-9531, Glucagon-like peptide-1, GLP-1, Semaglutide, Glucose-dependent Insulinotropic Peptide, GIP
Brief summary
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Interventions
Sponsors
Kailera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The participant and investigator will be blinded for participants randomized to KAI-9531 or placebo until the study is complete. Semaglutide will be provided open-label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * BMI ≥35 kilograms per square meter (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. * 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 the 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. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), 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 76 | Baseline, Week 76 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight | Baseline, Week 76 |
| Change From Baseline in Waist Circumference | Baseline, Week 76 |
| Change From Baseline in Absolute Body Weight | Baseline, Week 76 |
| Percentage of Participants with ≥5% Reduction in Body Weight | Baseline, Week 76 |
| Change From Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Triglycerides | Baseline, Week 76 |
| Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Non-HDL-cholesterol | Baseline, Week 76 |
| Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | Baseline, Week 76 |
| Percentage of Participants with ≥30% Reduction in Body Weight | Baseline, Week 76 |
| Change From Baseline in Body Mass Index (BMI) | Baseline, Week 76 |
| Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Positive Mood Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Craving for Sweets Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Craving for Savory Food Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Hunger Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Satiety Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Combined Score | Baseline, Week 76 |
| Change From Baseline in Food Noise Questionnaire (FNQ) Score | Baseline, Week 76 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Week 80 |
| Number of Participants With Anti-drug Antibodies (ADAs) | Up to Week 80 |
| Number of Participants With Neutralizing Antibodies (Nabs) | Up to Week 80 |
| Plasma Concentrations of KAI-9531 | Up to Week 76 |
Countries
Australia, United States
Contacts
CONTACTKailera Therapeutics, Inc.
Outcome results
None listed