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Human evidence record · Tesofensine

Tesofensine Phase II obesity trial

Weight loss with tesofensine was 4.5%, 9.2% and 10.6% greater than the 2.0% placebo/diet response; authors called for Phase III confirmation.

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 obesity

How many?

n=203

What happened?

Weight loss with tesofensine was 4.5%, 9.2% and 10.6% greater than the 2.0% placebo/diet response; authors called for Phase III confirmation.

What stops us overclaiming?

Older Phase II study; long-term cardiovascular benefit-risk and approval were not established by this trial.

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Key result

Weight loss with tesofensine was 4.5%, 9.2% and 10.6% greater than the 2.0% placebo/diet response; authors called for Phase III confirmation.

Study details

Study designRandomized double-blind placebo-controlled trial
PhasePhase II
PopulationAdults with obesity
Sample size203
RouteOral
Regimen / exposure0.25, 0.5 or 1.0 mg once daily
Duration24 weeks
ComparatorPlacebo plus diet
Primary endpoint / questionPercent body-weight change
Safety resultDry mouth, nausea, constipation and insomnia were common; 0.5 mg increased heart rate by about 7.4 bpm.
Key limitationsOlder Phase II study; long-term cardiovascular benefit-risk and approval were not established by this trial.
Registry / identifierPMID 18950853 / NCT00394667
Evidence verified2026-09-18