This study is on a voluntary pause while the company works to secure funding.
Study Purpose
Tesomet is a first-in-class triple monoamine re-uptake inhibitor / beta-1 blocker which is being studied as a possible treatment for hyperphagia in Prader-Willi syndrome.
Do you qualify for this study? Click here to find out!
Recruitment Criteria
Study Type: double-blind, randomized, placebo-controlled
Eligible Ages: 18 - 65 years, 13-17-year-olds will be enrolled at a later date TBD.
Trial Details
Trial Id: NCT05198362
Phase: 2b
Duration: 16 to 18 weeks double-blind, followed by optional 38-week open-label extension
Status: enrolling
Lead Sponsor: Saniona
Countries: United States and other countries to be announced
Eligibility Criteria
- Male or female, 13 through 65 years of age (not yet enrolling ages 13-17)
- Participants ages 18 to 65 years: BMI of 27 to 60 kg/m2;
- Participants ages 13 to 17 years: BMI that is at least 85th percentile for age and sex;
- Diagnosed with PWS
- Have a regular caregiver
- If taking, must be on a stable dose of growth hormone, antidiabetic medications, and/or lipid-lowering medications
- Must not be taking antidepressants
This Study is enrolling at the following sites:
Sparrow Clinical Research Institute
Lansing, Minnesota
Indiana University
Indianapolis, Indiana
Rare Disease Research LLC
Atlanta, Georgia
For the most up to date information and contact information for trial sites, please visit: www.sanionapwsstudy.com
