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Evidence brief

What the belly-fat trials found

The main studies measured deep belly fat in adults with HIV, not weight loss in the general public.

Fact check:

The two main trials

The larger early trial

HIV is the virus that the people in these studies had.

The Falutz paper published in 2007 described 412 adults with extra belly fat and HIV.

The trial ran for 26 weeks and compared tesamorelin with a placebo, an injection with no active medicine.

The paper reported deep belly fat falling by 15.2% with tesamorelin and rising by 5.0% with the placebo.

The percentages here come from the published study. The drug label uses a different calculation, so its percentages differ. Read these numbers as the study report; the label gives a separate calculation of the same trial.

The next trial found a smaller drop

In the 2010 Falutz trial, 404 adults took part.

At six months, the tesamorelin group had a 10.9% drop in deep belly fat; the placebo group had a 0.6% drop.

These results concern that study group, rather than a promise for an individual.

The change did not simply stay after stopping

In both main trials, people changed to placebo after 26 weeks regained belly fat during the next 26 weeks.

Body weight barely moved in the main studies.

Ask how the person treating you would judge a useful change and when to review the plan.

Keep this in mind

The evidence is about deep belly fat in a defined HIV group, with ongoing treatment needed to keep the trial benefit.