* Phase 2b Study of Tesomet in Subjects with HO (TM008)
Research type
Research Study
Full title
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose finding, Multi-center, 36-week Safety and Efficacy Study with Open-label Extension Period of Tesomet in Subjects with Hypothalamic Obesity
IRAS ID
303420
Contact name
Lucinda Summers
Contact email
Sponsor organisation
Saniona A/S
Eudract number
2021-000146-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Research Summary
Hypothalamic obesity (HO) is characterised by significant weight gain that can occur after damage to the hypothalamus, which is a part of the brain that is responsible for controlling hunger amongst many other functions. People with HO often have a higher than normal sensation of hunger and a low metabolic rate leading to excessive weight gain.
A wide range of drug treatments have been attempted to combat HO but the results have been varied. Surgery to reduce the size of the stomach is also an option, but it is an intensive and invasive procedure and there are few published studies in this population to support its use. Tesomet, the medication being investigated in this study, is a combination therapy of two agents; tesofensine, which has demonstrated clinically significant weight reducing effects, and metoprolol, an established medication prescribed for hypertension, angina pectoris, and heart failure.
TM008 is a Phase 2b, double-blind, randomised, placebo-controlled, multicentre study of Tesomet versus placebo in adult and adolescent participants with HO. The primary objectives of the study are to examine the efficacy (by reduction of body weight), safety and tolerability of several dose levels of Tesomet over 36 weeks in adult participants with HO 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 optional 36-week 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 104 participants will be randomised into the study. Recruitment in the UK will take place in hospitals. 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
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0199
Date of REC Opinion
27 Sep 2021
REC opinion
Further Information Favourable Opinion