Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients

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)

The Sponsor will consider requests from qualified researchers for access to TM008 study materials

Following completion of Tesomet clinical development