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by Robert MacKay, Sunday, October 27, 2013 | Categories: Tesofensine

We have written about the potential weight loss drug Tesofensine in the past and we have now become aware of an issue with the Phase II clinical trials in Denmark that we should expose to our readers. Tesofensine was shown to induce an impressive level of weight loss over a 6 month period at the top dose administered. The average weight loss at the top dose was 10.6% over the 6 month period. Even at the lowest daily dose, the average weight loss of just under 5% over 6 months is not too bad.

The problem with the study is that irregularities were discovered at two of the datacentres where adverse events may have been under-reported as members of staff were wrongly instructed not to record events if the patients had experienced similar side effects before randomisation on the trial. Clearly this instruction was wrong and could potentially undermine the apparently good safety profile of this medication.

The Danish company that holds the patent for Tesofensine is still looking for a partner to develop this medication. It is our understanding that protocols for a Phase III trial have been agreed with regulators but no partner has been found so the drug is in a state of limbo. Given that Tesofensine has a mode of action similar to the now withdrawn Sibutramine (Reductil), the patent-holder may continue to experience difficulties in recruiting a partner and the irregularities in the Phase II trial sites can only exacerbate matters in our view.

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