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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05147415
Recruitment Status : Suspended (The decision to voluntarily pause the trial is entirely a result of program reprioritization due to funding limitations and is not related to the safety or efficacy of Tesomet.)
First Posted : December 7, 2021
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Hypothalamic Obesity Other: Placebo Drug: Tesomet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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
Other: Placebo
Inactive comparator

Drug: Tesomet
Fixed-dose combination
Other Names:
  • tesofensine
  • metoprolol

Experimental: Tesomet Low Dose
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
Drug: Tesomet
Fixed-dose combination
Other Names:
  • tesofensine
  • metoprolol

Experimental: Tesomet Medium Dose
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
Drug: Tesomet
Fixed-dose combination
Other Names:
  • tesofensine
  • metoprolol

Experimental: Tesomet High Dose
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
Drug: Tesomet
Fixed-dose combination
Other Names:
  • tesofensine
  • metoprolol




Primary Outcome Measures :
  1. Body weight (%) [ Time Frame: Baseline to Week 36 ]
    Percentage change in body weight


Secondary Outcome Measures :
  1. Body weight loss [ Time Frame: Week 36 ]
    Proportion of subjects who meet pre-specified thresholds for body weight loss

  2. Body weight (kg) [ Time Frame: Baseline to Week 36 ]
    Change in body weight in kilograms

  3. Waist circumference (cm) [ Time Frame: Baseline to Week 36 ]
    Change in waist circumference in centimeters

  4. Body Mass Index (BMI) [ Time Frame: Baseline to Week 36 ]
    Change in BMI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147415


Locations
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United States, Michigan
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Saniona
Investigators
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Study Director: Sophie Guillaume, MS Saniona
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Responsible Party: Saniona
ClinicalTrials.gov Identifier: NCT05147415    
Other Study ID Numbers: TM008
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Sponsor will consider requests from qualified researchers for access to TM008 study materials
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Following completion of Tesomet clinical development

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action