Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)

• Status: Completed
• Trial end date: 2019-06-17
• Target enrollment: 0
• Participant gender: All

Summary

Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saniona
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

1. Males and females

2. Confirmed genetic diagnosis of Prader-Willi syndrome

3. Age: Step 1: Adults aged 18-30 b. Step 2: Children aged 12-17

4. BMI:

1. Step 1: Adults with ≥25 kg/m2

2. Step 2: Children with a BMI >85th percentile for the same age and sex

5. Normal BP or well managed hypertension (only if dose of BP medication(s) has been stable for >2 months)

6. Normal lipid profile or well managed dyslipidemia (only if dose of lipid-lowering medication(s) has been stable for >2 months)

7. On stable dose of growth hormone >2 months

Exclusion Criteria:

1. Hypersensitivity to tesofensine/metoprolol

2. Type 1 diabetes

3. Heart failure NYHA level II or greater, decompensated heart failure

4. Previous myocardial infarction or stroke

5. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other DSM-III disorders, which in the investigator's opinion will interfere significantly with study compliance