Study record · Tesofensine
Tesofensine for weight loss in obesity
Placebo-adjusted mean weight reductions were approximately 4.5%, 9.2% and 10.6% across the three dose groups.
Key result
Placebo-adjusted mean weight reductions were approximately 4.5%, 9.2% and 10.6% across the three dose groups.
Study details
Study designRandomized, double-blind, placebo-controlled dose-ranging trial
PhasePhase II
PopulationAdults with obesity
Sample size203
RouteOral
Regimen / exposure0.25, 0.5 or 1.0 mg once daily plus energy-restricted diet
Duration24 weeks
ComparatorPlacebo plus diet
Primary endpoint / questionPercent body-weight change
Safety resultDry mouth, nausea, constipation, hard stools, diarrhea and insomnia were common; heart rate increased by about 7.4 bpm in the 0.5 mg group.
Key limitationsOlder Phase II study; results require context from later development and combination-with-metoprolol work.
Registry / identifierPMID 18950853 / NCT00394667