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Trial record 1 of 3 for:    Tesomet
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Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome (PWS)

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: NCT05198362
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 : January 20, 2022
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 with PWS.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Other: Placebo Drug: Tesomet Phase 2

Detailed Description:
For the double-blind portion of the study, dosing will be initiated in a subgroup of adults who are 18-65 years of age. Following independent Data Monitoring Board review of subgroup safety data, and review and confirmation to proceed by FDA, enrollment of subjects <18 years of age will commence.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Once-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of 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 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of 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 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of 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 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated dose from the double-blind period
Drug: Tesomet
Fixed-dose combination
Other Names:
  • tesofensine
  • metoprolol




Primary Outcome Measures :
  1. Hyperphagia [ Time Frame: Baseline to Week 16 ]
    Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score


Secondary Outcome Measures :
  1. Change in Body Weight [ Time Frame: Baseline to Week 16 ]
    Percentage change in body weight

  2. Hyperphagia Severity (Caregiver) [ Time Frame: Baseline to Week 16 ]
    Change in caregiver rating of hyperphagia severity

  3. Hyperphagia Change (Caregiver) [ Time Frame: Week 16 ]
    Proportion of caregiver responses for change in subject's hyperphagia

  4. PWS Severity (Clinician) [ Time Frame: Baseline to Week 16 ]
    Change in clinician rating of the subject's PWS severity

  5. Overall Status Change (Clinician) [ Time Frame: Week 16 ]
    Proportion of clinician responses for change in subject's overall clinical status



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subject and their legally authorized representative must be willing to provide informed consent
  • Confirmed genetic diagnosis of PWS
  • Body mass index (BMI) within the following range at Screening:

    1. Female and male subjects 18 to 65 years of age: 27 to 60 kg/m2; or
    2. Female and male subjects 13 to 17 years of age with BMI that is at least 85th percentile for age and sex;
  • Female subjects must be of non-child-bearing potential
  • Documented stable body weight
  • Moderate hyperphagia at Screening and at Baseline
  • Participants must have a reliable and stable caregiver who should be able to spend an adequate amount of time with the participants to be able to address behaviors, activities and symptoms
  • 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. Adult subjects with systolic BP >/=145 mmHg or <100 mmHg; or
    2. Adult subjects with diastolic BP >/=95 mmHg or <70 mmHg; or
    3. Adolescent subjects with a systolic or diastolic BP that is 95th percentile or greater for age and sex
  • Type 1 diabetes mellitus
  • History of dementia (eg, Alzheimer's disease, Parkinson's disease)
  • History of bulimia or anorexia nervosa
  • History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder), or symptoms of delusions, hallucinations, or mania/hypomania within 90 days prior to Screening, as described by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
  • Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)
  • Medical condition or recent systemic infection that, in the opinion of the Investigator, could impact the safety of the subject
  • Use of prohibited medications, including current use of 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): NCT05198362


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: NCT05198362    
Other Study ID Numbers: TM006
First Posted: January 20, 2022    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 TM006 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
Keywords provided by Saniona:
hyperphagia
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
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