WithdrawnPhase 2

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

Stopped: Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients

United States0Started 2021-12-28

Plain-language summary

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

Who can participate

Age range13 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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

What they're measuring

Hyperphagia

Timeframe: Baseline to Week 16

Trial details

NCT IDNCT05198362

SponsorSaniona

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-09

View on ClinicalTrials.gov More Prader-Willi Syndrome trials