Clinical Trials Pave The Way For PWS Treatments

PWS clinical trials are taking place around the world to help us understand Prader-Willi syndrome and investigate new treatments; please see the list below for active and pending clinical trials. Click on the link at the left of each column for additional information about each of the clinical trials that are active or are about to start. We encourage you to learn more about these clinical trials, talk with your physician about potential risks and benefits, and ask questions to help you decide if enrolling in a clinical trial is right for you or your loved one with PWS.

You can watch a video on clinical trials here or by clicking on the embed below. To learn more about clinical trials and the questions you might want to ask as a potential participant, check out this page on the NIH website

Your participation is key to moving potential therapies forward. If you or someone you care for has PWS, learn about clinical trials by subscribing to FPWR's Clinical Trial Alerts — just fill out the form below!


Sign Up For PWS Clinical Trial Alerts

PWS Clinical Trials In Progress / Starting Soon

Drug / link Phase Sponsor Status Primary Target Ages BMI / WT # Patients Length Site Locations


 Phase 3  Levo Therapeutics Recruiting  Hyperphagia, behavior    7-18  n/a  ~175  8w dbl blind + 56w extension AL, AZ, CA, CO, DC, FL, IL, KA, MA, MN, MI, OH PA, TN, TX, UT


 Phase 3  Soleno Therapeutics  Recruiting  Hyperphagia  4+ 20* - 130 kg  ~100 15w dbl blind + 9m extension CA, CO, FL, GA, KS, MA, MD, MI, MN, NY, OH, TN, UT, WA


Phase 2b/3  Millendo Recruiting  Hyperphagia  4-65  < 65 kg/m2   ~150  12w dbl blind + 9m extension AL, CA, CO, KS, MA, MD, MI, MN, NY, TN, TX, WA, Australia, Belgium, France, Italy, Netherlands, Spain, UK


Phase 4 NYU Langone Health Recruiting Aggression, self-injurious behavior 6 - 35 n/a 33 19 w



Phase 3 NovoNordisk Recruiting BMI - weight loss 6-18 30 kg/m2 or BMI > 95th percentile   52w

MD, NY, International


Phase 2 GLWL Research Closed Hyperphagia 16 - 65 27 - 60 kg/m2 34 18w


 Oxytocin Phase 2 Montefiore Medical Center Recruiting Hyperphagia, Repetitive Behavior 5 - 17 n/a 50 8w NY
Tesomet Phase 2, Part 2  Saniona complete   Hyperphagia, Weight loss  12-17   BMI > 85th percentile   10-15 12w   Czechia

Find a Trial Near You!

Click on the pins for more trial information.

Non-Medication PWS Studies

Study / Link Type Investigator Status Area of Research Ages Length Site Locations

Acceptance and Commitment Training (ACT) 

Intervention Dr. Forster  Recruiting  Family Stress   13 - 18 4 sessions web based

Chronic Stress, Cognition and Food Cue Reactivity

Exploratory Dr. Jill Hamilton Recruiting Stress and Appetite 7 - 16 2 visits SickKids
Toronto, CA


Natural History Theresa Strong, PhD Ongoing - not recruiting Serious Medical Events 5+ 4 years virtual

Home-Based SSP on Individuals with PWS

Exploratory Dr. Stephen Porges, Integrated Listening Systems Recruiting Sensory Sensitivities, Behavior 3 - 15  1 week remote

Mindfulness-based intervention for temper outbursts in PWS

Intervention Dr. Stewart Einfeld Recruiting Temper Outbursts 13-30 18 weeks

web based

Parent-focused Remote Education to Enhance Development (PRETEND)

Social Intervention

Dr. Anastasia Dimitropoulos Recruiting Social behavior 6-9 8w

Remote with 2 in-person visits


Oxytocin and the Autonomic Nervous System in PWS


Dr. Stewart Einfeld Recruiting Oxytocin 13-30 1 visit

University of Sydney,
Royal Children's Hospital, Victoria

PWS Clinical Trials Overview Video


How Patients Can Partner

Download PWS Clinical Trial Webinar Slides

PWS Clinical Trials Directory

For more in-depth details about individual PWS clinical trials, visit our PWS Clinical Trials Directory.


FPWR does not endorse or recommend any specific study. Our goal is to provide information to help members of the PWS community decide whether participation in a clinical trial is right for them and their loved one with PWS.  Anyone considering participating in a clinical trial should discuss the matter with his or her physician. 

PWS Clinical Trials FAQ

Download the PWS Clinical Trials FAQ Sheet