Human evidence 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.

Quick read

Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults with hypothalamic obesity

How many?

n=21

What happened?

Tesomet produced an additional mean weight change of -6.3 percentage points versus placebo; 8/13 achieved >=5% weight loss versus 1/8 placebo.

What stops us overclaiming?

Very small disease-specific study; combination evidence cannot be treated as tesofensine-monotherapy evidence.

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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

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