NCT07284875 · Kailera
Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
What this study is about
The primary objective of the study is to determine the effects of KAI-9531 injected under the skin (SC) injection once weekly compared to placebo on percent change in body weight.
View original scientific description
The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
- hypertension,
- dyslipidemia,
- obstructive sleep apnea, or
- cardiovascular (CV) disease.
- History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
Exclusion criteria
- Current diagnosis or history of diabetes mellitus.
- 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 motility.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.
Where
- Anniston, Alabama
- Birmingham, Alabama
- Cullman, Alabama
- Sun City, Arizona
- Escondido, California
- Toluca Lake, California
- Aurora, Colorado
- Bridgeport, Connecticut
- Jupiter, Florida
- Lilburn, Georgia
- Springfield, Illinois
- Columbia, Maryland
And 12 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations