Status:
WITHDRAWN
Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome
Lead Sponsor:
Saniona
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
13-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.
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 ...
Eligibility Criteria
Inclusion
- Key
- 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:
- Female and male subjects 18 to 65 years of age: 27 to 60 kg/m2; or
- 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
- 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:
- Adult subjects with systolic BP \>/=145 mmHg or \<100 mmHg; or
- Adult subjects with diastolic BP \>/=95 mmHg or \<70 mmHg; or
- 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
Key Trial Info
Start Date :
December 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05198362
Start Date
December 28 2021
End Date
December 9 2022
Last Update
December 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912