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Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight and Diabetes
EU CTIS ID: 2025-523510-87-00
What this study is testing
To demonstrate KAI-9531 SC QW is superior to placebo on percent change in body weight and change in hemoglobin A1c (HbA1c)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of 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/glucosedependent insulinotropic polypeptide receptor (GIPR) dual agonist, or DPP-4 inhibitors
- BMI ≥27 kg/m2
- History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
You likely can't join if
- Current diagnosis or history of T1DM or any other type of diabetes except T2DM.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety 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.
- 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.
See the full eligibility criteria
- Diagnosis of 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/glucosedependent insulinotropic polypeptide receptor (GIPR) dual agonist, or DPP-4 inhibitors
- BMI ≥27 kg/m2
- History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
- Current diagnosis or history of T1DM or any other type of diabetes except T2DM.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety 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.
- 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 (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility if taken for >30 days continually within 3 months prior to Screening.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- United States
- United Kingdom
- Argentina
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; United States; United Kingdom; Argentina; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.