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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT05198362
• Date of registration: 05/01/2022
• Prospective Registration: No
• Primary sponsor: Saniona
• Public title: Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome PWS
• Scientific 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
• Date of first enrolment: December 28, 2021
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT05198362
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Sophie Guillaume, MS
• Affiliation: Saniona

Key inclusion & exclusion 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



Age minimum: 13 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Intervention(s)

Drug: Tesomet

Other: Placebo

Primary Outcome(s)

Hyperphagia [Time Frame: Baseline to Week 16]

Secondary Outcome(s)

Hyperphagia Change (Caregiver) [Time Frame: Week 16]

Change in Body Weight [Time Frame: Baseline to Week 16]

Overall Status Change (Clinician) [Time Frame: Week 16]

Hyperphagia Severity (Caregiver) [Time Frame: Baseline to Week 16]

PWS Severity (Clinician) [Time Frame: Baseline to Week 16]

Secondary ID(s)

TM006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors