What this trial means for you
This study is recruiting now at 34 US sites. It's studying KAI-9531, Placebo for obesity with diabetes, overweight with diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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)
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Alabama
- Kailera Clinical Site — Cullman · Recruiting now
Arizona
- Kailera Clinical Site — Phoenix · Recruiting now
- Kailera Clinical Site — Sun City · Recruiting now
Arkansas
- Kailera Clinical Site — Little Rock · Recruiting now
California
- Kailera Clinical Site — Escondido · Recruiting now
- Kailera Clinical Site — Northridge · Recruiting now
- Kailera Clinical Site — Oceanside · Recruiting now
- Kailera Clinical Site — Toluca Lake · Recruiting now
Connecticut
- Kailera Clinical Site — Stamford · Recruiting now
Florida
- Kailera Clinical Site — Jupiter · Recruiting now
- Kailera Clinical Site — Orange City · Recruiting now
Georgia
- Kailera Clinical Site — Lilburn · Recruiting now
Illinois
- Kailera Clinical Site — Skokie · Recruiting now
- Kailera Clinical Site — Springfield · Active, not recruiting
Kansas
- Kailera Clinical Site — Newton · Recruiting now
Louisiana
- Kailera Clinical Site — Shreveport · Recruiting now
Maryland
- Kailera Clinical Site — Columbia · Recruiting now
Michigan
- Kailera Clinical Site — Farmington Hills · Recruiting now
Montana
- Kailera Clinical Site — Missoula · Recruiting now
Nebraska
- Kailera Clinical Site — Lincoln · Recruiting now
Nevada
- Kailera Clinical Site — Las Vegas · Recruiting now
New York
- Kailera Clinical Site — Albany · Recruiting now
- Kailera Clinical Site — Laurelton · Recruiting now
North Carolina
- Kailera Clinical Site — Greensboro · Recruiting now
- Kailera Clinical Site — Morehead City · Recruiting now
Oklahoma
- Kailera Clinical Site — Chickasha · Recruiting now
South Carolina
- Kailera Clinical Site — Spartanburg · Recruiting now
Tennessee
- Kailera Clinical Site — Chattanooga · Active, not recruiting
Texas
- Kailera Clinical Site — Amarillo · Recruiting now
- Kailera Clinical Site — Brownsville · Recruiting now
- Kailera Clinical Site — DeSoto · Recruiting now
- Kailera Clinical Site — Tomball · Recruiting now
Utah
- Kailera Clinical Site — Salt Lake City · Recruiting now
Virginia
- Kailera Clinical Site — Richmond · Recruiting now
View the official record on ClinicalTrials.gov →
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