Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Saniona
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)
