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

Hypothalamic Obesity Clinical Trial

Official title:

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05147415
• Other study ID #: TM008
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 11, 2021
• Est. completion date: December 9, 2022

Study information

• Verified date: December 2022
• Source: Saniona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypothalamic Obesity
• Obesity

Intervention

Other:
• Placebo
Inactive comparator

Drug:
• Tesomet
Fixed-dose combination

Locations

Country	Name	City	State
United States	Sparrow Clinical Research Institute	Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Saniona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight (%)	Percentage change in body weight	Baseline to Week 36
Secondary	Body weight loss	Proportion of subjects who meet pre-specified thresholds for body weight loss	Week 36
Secondary	Body weight (kg)	Change in body weight in kilograms	Baseline to Week 36
Secondary	Waist circumference (cm)	Change in waist circumference in centimeters	Baseline to Week 36
Secondary	Body Mass Index (BMI)	Change in BMI	Baseline to Week 36