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Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
1700 patients around the world
Available in United States, Argentina
Kailera
1700Patients around the world
This study is for people with
Obesity
Diabetes
Diabetes mellitus type 2
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
SponsorKailera
Study typeInterventional
Conditions
ObesityDiabetes mellitus type 2
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07284901
