NCT05198362

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

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Saniona · Industry
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

For the double-blind portion of the study, dosing will be initiated in a subgroup of adults who are 18-65 years of age. Following independent Data Monitoring Board review of subgroup safety data, and review and confirmation to proceed by FDA, enrollment of subjects \<18 years of age will commence.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
OTHER	Placebo	Inactive comparator
DRUG	Tesomet	Fixed-dose combination

Timeline

• Start date: 2021-12-28
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2022-01-20
• Last updated: 2022-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study