Phase 2b Study of Tesomet - PAUSED

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