Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder

Exclusion Criteria

• •Medical Conditions
• •Eating disorder-related
• •8. Current diagnosis of bulimia nervosa or anorexia nervosa
• •Diabetes-related
• •9. Have type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
• •10. Have laboratory evidence diagnostic of diabetes mellitus during screening, including an HbA1c ≥6.5% or fasting glucose \>126 mg/dL
• •Obesity-related:
• •11. Have a self-reported change in body weight \>5 kg within 3 months prior to screening
• •12. Have a prior or planned surgical treatment for obesity (excluding lap-band if removed \>6 months prior to screening or liposuction or abdominoplasty if performed \>1 year prior to screening)
• •13. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal bypass sleeve)
• •Other medical
• •Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2
• •Known serious hypersensitivity to tirzepatide or lisdexamfetamine dimesylate or any of the excipients in the medications
• •Have severe gastrointestinal disease
• •Have known clinically significant renal impairment
• •Have uncontrolled medical conditions or contraindications to tirzepatide or lisdexamfetamine dimesylate
• •Have personal or family history of cardiovascular disease that could increase vulnerability to sympathomimetic effects of psychostimulants
• •Have a history of suspected substance abuse within the past 5 years
• •Have a lifetime history of psychostimulant abuse and/or dependence
• •Have glaucoma
• •Have had a history of chronic or acute pancreatitis
• •Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome)
• •Have a current diagnosis of attention-deficit/hyperactivity disorder
• •Have a history of significant active or unstable Major Depressive Disorder (MDD; within the last 2 years) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, psychosis, mania, hypomania, or other serious mood or anxiety disorder) Note: Patients with MDD or generalized anxiety disorder whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if not on excluded medications
• •Have a Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at Visit 1 or 2, prior to randomization
• •Have any lifetime history of a suicide attempt
• •Individual is considered a suicide risk in the opinion of the investigator; or endorsement of current, active suicidal ideation at screening or randomization. On the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visits 1 or 2, prior to randomization:
• •* a "yes" answer to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or
• •* a "yes" answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS or
• •* a "yes" answer to any of the suicide-related behaviors (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Act or Behavior) on the "Suicidal Behavior" portion of the C-SSRS and
• •* the ideation or behavior occurred within the past month
• •Have taken monoamine oxidate inhibitors (MAOI), or within 14 days of stopping MAOIs
• •Have uncontrolled hypertension (SBP above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
• •Have any of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina
• •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
• •History of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, Parkinson's disease, or intracranial lesions
• •Participant has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place the participant at increased vulnerability to the sympathomimetic effects of a stimulant medication
• •Have a history of any other condition that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
• •Prior/Concomitant Therapy
• •Are receiving concurrent treatment for eating or weight disorders
• •Use of a psychostimulant within the past 6 months
• •Have taken within 3 months prior to screening, medications (prescribed or over-the counter) intended to promote weight loss. Examples include, but are not limited to
• •* Saxenda® (liraglutide 3.0 mg)
• •* Xenical®/Alli® (orlistat)
• •* Meridia® (sibutramine)
• •* Adipex® (phentermine)
• •* BELVIQ® (lorcaserin)
• •* Qsymia® (phentermine/topiramate combination)
• •* Contrave® (naltrexone/bupropion)
• •* Ozempic or Wegovy (semaglutide)
• •* Mounjaro or Zepbound (tirzepatide)
• •* Rybelsus (semaglutide)
• •Prior/Concurrent Clinical Study Experience
• •Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study