RECRUITINGPhase 3INTERVENTIONAL
Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
About This Trial
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)
Who May Be Eligible (Plain English)
Key Who May Qualify:
- 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 Who Should NOT Join This Trial:
- 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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/exclusion criteria may apply, per protocol.
Treatments Being Tested
DRUG
KAI-9531
SC Injection
DRUG
Placebo
SC Injection
Locations (20)
Kailera Clinical Site
Cullman, Alabama, United States
Kailera Clinical Site
Phoenix, Arizona, United States
Kailera Clinical Site
Sun City, Arizona, United States
Kailera Clinical Site
Little Rock, Arkansas, United States
Kailera Clinical Site
Escondido, California, United States
Kailera Clinical Site
Northridge, California, United States
Kailera Clinical Site
Oceanside, California, United States
Kailera Clinical Site
Toluca Lake, California, United States
Kailera Clinical Site
Stamford, Connecticut, United States
Kailera Clinical Site
Jupiter, Florida, United States
Kailera Clinical Site
Lilburn, Georgia, United States
Kailera Clinical Site
Springfield, Illinois, United States
Kailera Clinical Site
Shreveport, Louisiana, United States
Kailera Clinical Site
Missoula, Montana, United States
Kailera Clinical Site
Las Vegas, Nevada, United States
Kailera Clinical Site
Albany, New York, United States
Kailera Clinical Site
Greensboro, North Carolina, United States
Kailera Clinical Site
Morehead City, North Carolina, United States
Kailera Clinical Site
Chickasha, Oklahoma, United States
Kailera Clinical Site
Spartanburg, South Carolina, United States