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Trial · Interventional

WithdrawnPhase 2Registry data

Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome

Short name PWS

NCTNCT05198362 (opens ClinicalTrials.gov in a new tab)Other idTM006
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
Saniona · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
28 Dec 2021
Primary completion
9 Dec 2022
Completion
9 Dec 2022
First posted
20 Jan 2022
Last update posted
13 Dec 2022
Conditions
Prader-Willi Syndrome

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 2

    PWS

    NCT05198362

    28 Dec 2021 to 9 Dec 2022

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.

Interventions

  • PlaceboOther
  • TesometDrug

Arms4

  • 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

  • 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

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Hyperphagia

    Time frame · Baseline to Week 16

    Registry description

    Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score

Secondary outcomes(5)

  1. Change in Body Weight

    Time frame · Baseline to Week 16

    Registry description

    Percentage change in body weight

  2. Hyperphagia Severity (Caregiver)

    Time frame · Baseline to Week 16

    Registry description

    Change in caregiver rating of hyperphagia severity

  3. Hyperphagia Change (Caregiver)

    Time frame · Week 16

    Registry description

    Proportion of caregiver responses for change in subject's hyperphagia

  4. PWS Severity (Clinician)

    Time frame · Baseline to Week 16

    Registry description

    Change in clinician rating of the subject's PWS severity

  5. Overall Status Change (Clinician)

    Time frame · Week 16

    Registry description

    Proportion of clinician responses for change in subject's overall clinical status

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 13 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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