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Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

1800 patients around the world

Available in United States, Argentina

Kailera

1800Patients around the world

This study is for people with

Obesity

From 18 Years

All Gender

: 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.
Cardiovascular (CV) disease.
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.
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.

SponsorKailera

Study typeInterventional

Conditions

Obesity

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07284875