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Human & clinicalPeer-reviewed2010

Tesamorelin in HIV-associated abdominal fat — randomized controlled trial

PubMed

TL;DR

In 404 people with HIV-associated abdominal fat accumulation, daily tesamorelin significantly reduced visceral fat over six months, and continued treatment maintained further reductions.

Randomized · double-blind · placebo-controlled · 404 participants

What was studied

The question.

Whether tesamorelin could reduce excess visceral abdominal fat in people with HIV receiving antiretroviral therapy.

How it was conducted

The study design.

Participants were randomized 2:1 to daily 2 mg subcutaneous tesamorelin or placebo for six months. A blinded extension then followed participants through 12 months, including rerandomization of the original tesamorelin group.

What it found

Did it actually work?

  • Visceral adipose tissue fell by 10.9% with tesamorelin versus 0.6% with placebo at six months.
  • Waist measures and patient-rated abdominal appearance improved.
  • People who continued tesamorelin reached roughly an 18% reduction in visceral fat by 12 months, while improvements were lost after switching to placebo.

Why it matters

How to read this result.

This is direct controlled human evidence for the clinical effect that ultimately defines tesamorelin's approved role in HIV-associated lipodystrophy.

Keep in mind

What the study does not prove.

  • The studied population had HIV-associated abdominal fat accumulation, not general obesity.
  • The historical trial dose differs from current product-specific prescribing instructions.

Original source

Want to read the original?

We summarize the study here first. The original source is there when you want the full methods, statistics, tables and author discussion.

Open ClinicalTrials.gov record