Study record · Tesofensine
Tesomet for weight loss in hypothalamic obesity
Tesomet produced an additional mean weight change of -6.3 percentage points versus placebo; 8/13 achieved >=5% weight loss versus 1/8 placebo.
Key result
Tesomet produced an additional mean weight change of -6.3 percentage points versus placebo; 8/13 achieved >=5% weight loss versus 1/8 placebo.
Study details
Study designRandomized, placebo-controlled trial
PopulationAdults with hypothalamic obesity
Sample size21
RouteOral
Regimen / exposureTesofensine 0.5 mg + metoprolol 50 mg daily
Duration24 weeks
ComparatorPlacebo
Primary endpoint / questionSafety plus body weight, appetite and metabolic outcomes
Safety resultOne Tesomet-related serious adverse event involved exacerbation of pre-existing anxiety; sleep disturbance, dry mouth and headache were common.
Key limitationsVery small disease-specific study; combination evidence cannot be treated as tesofensine-monotherapy evidence.
Registry / identifierPMID 35294397