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Efficacy and Safety of KAI-9531 compared with Semaglutide in Participants Living With Obesity Who Do Not Have Diabetes
EU CTIS ID: 2025-523511-11-00
What this study is testing
To demonstrate that KAI-9531 subcutaneous (SC) once weekly (QW) is superior to semaglutide SC QW and placebo SC QW on percent change in body weight
- 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
- BMI ≥35 kg/m
- 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 diabetes mellitus
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months 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 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
See the full eligibility criteria
- BMI ≥35 kg/m
- 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 diabetes mellitus
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months 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 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 (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; United Kingdom. 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.