Obesity With Diabetes, Overweight With Diabetes
Conditions
Keywords
Obesity, Overweight, KAI-9531, Glucagon-like peptide-1, GLP-1, Diabetes, 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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)
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: * Diagnosis of type 2 diabetes mellitus (T2DM). * Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) dual agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitors. * BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM. * History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening. * History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening. * 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 (GI) motility if taken for \>30 days continually within 3 months prior to Screening. * 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, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening. Note: Additional inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Doses 3 and 4 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 | Baseline, Week 76 |
| Doses 3 and 4 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76 | Baseline, Week 76 |
Secondary
| Measure | Time frame |
|---|---|
| Doses 1 and 2 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 | Baseline, Week |
| Doses 1 and 2 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76 | Baseline, Week 76 |
| Percentage of Participants with ≥5%, ≥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 HbA1c <7% and ≤6.5% | Baseline, Week 760 |
| Change From Baseline in Fasting Blood Glucose | 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 |
| Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight | Baseline, Week 76 |
| Percentage of Participants with ≥30% Reduction in Body Weight | Baseline, Week 76 |
| Change From Baseline in BMI | Baseline, Week 76 |
| Percentage of Participants with HbA1c <5.7% | Baseline, Week 76 |
| Change From Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Total Cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Insulin | 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, New Zealand, United States
Contacts
CONTACTKailera Therapeutics, Inc.
Outcome results
None listed