Phase 2b Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2b, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 16 years of age or older, with HO

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saniona
• Treatments: Metoprolol

Criteria

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 of childbearing potential must have a negative serum pregnancy test

• Female subjects of childbearing potential and male subjects must be willing to use a highly effective form of birth control during the study

• 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

Key Exclusion Criteria:

• 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

• Active clinical symptoms of delusions, hallucinations, major depressive disorder, hypomania, or suicidality within 90 days prior to Screening, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)

• 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)