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

Phase 2

Withdrawn

• Conditions: Hypothalamic Obesity
• Interventions: Other: Placebo; Drug: Tesomet

• Registration Number: NCT05147415
• Lead Sponsor: Saniona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-07
• Status Verified: 2022-12
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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
Placebo	Tesomet	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
Tesomet Low Dose	Tesomet	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
Tesomet Medium Dose	Tesomet	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
Tesomet High Dose	Tesomet	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

Primary Outcome Measures

Name	Time	Method
Body weight (%)	Baseline to Week 36	Percentage change in body weight

Secondary Outcome Measures

Name	Time	Method
Body weight loss	Week 36	Proportion of subjects who meet pre-specified thresholds for body weight loss
Body weight (kg)	Baseline to Week 36	Change in body weight in kilograms
Waist circumference (cm)	Baseline to Week 36	Change in waist circumference in centimeters
Body Mass Index (BMI)	Baseline to Week 36	Change in BMI

Trial Locations

Locations (1)

Sparrow Clinical Research Institute; 🇺🇸 Lansing, Michigan, United States