By IANS,
Washington : Trials with a promising new drug has shown that it can double the weight loss caused by current obesity drugs in the market, according to a Danish study.
Danish company Neurosearch and a number of researchers at the Faculty of Life Sciences at University of Copenhagen are behind development of Tesofensine, the drug which is likely to be taken up further in phase III trials.
Tesofensine – which inhibits the presynaptic uptake of the neurotransmitters noradrenaline, dopamine and serotonin in the brain – has been shown to be safe and effective in animal models.
It also caused unintended weight loss when it was given to obese patients with Parkinson’s or Alzheimer’s disease when it was researched for those conditions. The drug works by suppressing hunger, leading to an energy deficit which burns off excess body fat, according to a release of University of Copenhagen.
This randomised, placebo-controlled phase II study was done in five Danish obesity management centres, and involved 203 obese patients, weighing a mean of just over 100 kg.
They were prescribed a limited-energy diet and assigned tesofensine 0.25mg (52 patients), 0.5 mg (50), 1.0 mg (49), or placebo (52), all once daily for 24 weeks.
The primary outcome was percentage change in bodyweight. A total of 161 patients completed the study, and an analysis showed that the mean weight loss recorded for placebo and diet was 2.2 kg and for tesofensine 0.25 mg, 0.5 mg and 1.0 mg it was 6.7 kg, 11.3 kg, and 12.8 kg, respectively.
For the 0.5 mg and 1.0 mg doses, this represented a weight loss around twice that attained using sibutramine or rimonabant*, the currently-approved therapies in Europe. Blood pressure was increased in the 1.0 mg group.
The most common side-effects caused by tesofensine were dry mouth, nausea, constipation, hard stools, diarrhoea and insomnia.
The authors conclude that the 0.5 mg dose of tesofensine is more promising than the 1.0 mg dose because it produces a similar weight loss with less side-effects.
These findings are scheduled for publication in a forthcoming issue of the Lancet.