Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity

This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO

Key Inclusion Criteria:

• Subject and, if applicable, their parent or legal guardian must be willing to provide informed consent
• Diagnosis of HO secondary to damage to the hypothalamus
• Female subjects must be of non-childbearing potential
• At least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence
• BMI 30.0 to 60.0 kg/m², inclusive
• Documented stable body weight (gain/loss <10%) for at least 90 days prior to Screening
• Stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for >2 months prior to Screening
• Male subjects who are sexually active must be surgically sterile

Key Exclusion Criteria:

• Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study

• Sitting BP that meets the following criteria after 5 minutes of rest at Screening:

  1. Systolic BP >145 mmHg or <100 mmHg; or
  2. Diastolic BP >95 mmHg or <70 mmHg

• Type 1 diabetes mellitus

• History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)

• Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)

• History of bulimia or anorexia nervosa

• Use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)