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

Saniona

Status and phase: Withdrawn; Phase 2

Conditions: Hypothalamic Obesity

Treatments: Other: Placebo; Drug: Tesomet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05147415

TM008

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated Tesomet dose from the double-blind period

Treatment:

Drug: Tesomet

Other: Placebo

Tesomet Low Dose

Experimental group

Description:

Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period

Treatment:

Drug: Tesomet

Tesomet Medium Dose

Experimental group

Description:

Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period

Treatment:

Drug: Tesomet

Tesomet High Dose

Experimental group

Description:

Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period

Treatment:

Drug: Tesomet