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

Prader-Willi Syndrome Clinical Trial

— PWS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05198362
• Other study ID #: TM006
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 28, 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 with PWS.

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.

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• Status: Withdrawn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: 13 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

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	Hyperphagia	Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score	Baseline to Week 16
Secondary	Change in Body Weight	Percentage change in body weight	Baseline to Week 16
Secondary	Hyperphagia Severity (Caregiver)	Change in caregiver rating of hyperphagia severity	Baseline to Week 16
Secondary	Hyperphagia Change (Caregiver)	Proportion of caregiver responses for change in subject's hyperphagia	Week 16
Secondary	PWS Severity (Clinician)	Change in clinician rating of the subject's PWS severity	Baseline to Week 16
Secondary	Overall Status Change (Clinician)	Proportion of clinician responses for change in subject's overall clinical status	Week 16