* Phase 2b Study of Tesomet in Subjects with PWS (TM006)
Research type
Research Study
Full title
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi center, 16-week Dose finding, Safety and Efficacy Study with Open-label Extension Period of Tesomet in Adult and Adolescent Subjects with Prader-Willi Syndrome
IRAS ID
302535
Contact name
Evelien Gevers
Contact email
Sponsor organisation
Saniona A/S
Eudract number
2021-000127-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 17 days
Research summary
Research Summary
Prader-Willi Syndrome (PWS) is a complex genetic condition that affects many parts and organ systems of the body. In infancy, this condition is characterised by weak muscle tone (hypotonia), feeding difficulties, poor growth, and delayed development. Beginning in childhood, affected individuals develop an insatiable appetite, which leads to chronic overeating (hyperphagia) resulting in obesity. Many individuals then develop type 2 diabetes and other co-morbidities, often leading to onset of cardiovascular disease. Mild to moderate intellectual impairment is typical, as well as behavioural problems, sleep abnormalities and issues with sexual development and fertility.
There is currently no treatment for the underlying pathology of PWS. Management and treatment for PWS involves addressing consequences of the syndrome during developmental milestones. Tesomet is a combination therapy of two agents; tesofensine, which has demonstrated clinically significant weight reducing effects, and metroprolol, an established medication prescribed for hypertension, angina pectoris, and heart failure.
TM006 is a Phase 2b, double-blind, randomised, placebo-controlled, multicentre study of Tesomet versus placebo in adult and adolescent participants with PWS. The primary objectives of the study are to examine the efficacy (by reduction of hyperphagia), safety and tolerability of several dose levels of Tesomet over 16 weeks in adult and adolescent participants with PWS and to inform the dose selections for the Phase 3 study. Eligible participants will be randomly assigned at equal ratios to receive 1 of 3 doses of Tesomet or matching placebo capsules.
An open-label extension part is included to investigate long-term safety and efficacy; all participants will receive the highest tolerated dose from the double-blind period.
Approximately 120 participants will be randomised into the study. The study is sponsored by Saniona.
Summary of Results
No participants were randomised to treatment in the clinical trial and therefore no study results are available.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
22/WM/0190
Date of REC Opinion
24 Aug 2021
REC opinion
Favourable Opinion