TH9507 in Patients With HIV-Associated Lipodystrophy
The pivotal Phase 3 trial that led to tesamorelin's 2010 FDA approval (as Egrifta) for reduction of excess visceral abdominal fat in HIV-infected adults with lipodystrophy. See the Tesamorelin Evidence Profile for the full regulatory picture, including why this approval doesn't extend to the UK or EU.
Lipodystrophy — abnormal fat redistribution, often with excess visceral abdominal fat — is a recognised complication of HIV and its treatment. Tesamorelin, a GHRH analogue, was developed specifically to address this by stimulating the body's own growth hormone release.
Randomized, double-blind, placebo-controlled, Phase 3
412 HIV-infected adults with excess abdominal fat
Tesamorelin 2mg subcutaneous once daily vs. placebo
What the registry says
Status: Completed. Ran June 2005 to April 2007. Results module confirms a completed Phase 3 interventional trial with 412 participants.
What published research found
Falutz et al., New England Journal of Medicine, 2007: a 15.2% reduction in visceral adipose tissue with tesamorelin vs. placebo — the primary finding this trial is known for, and the basis for the 2010 FDA approval.
What This Trial Tells Us
- Real, controlled, peer-reviewed human evidence that tesamorelin reduces visceral abdominal fat in HIV-associated lipodystrophy specifically.
- This is the kind of evidence (Level 4–5 on our evidence ladder) most compounds discussed in this space don't have.
What It Does NOT Tell Us
- Nothing about tesamorelin's effects in people without HIV-associated lipodystrophy — a genuinely different population this trial didn't study.
- Nothing about general fat loss, anti-ageing, or athletic performance claims — those extend well beyond what this trial measured.
- Nothing about UK or EU approval — the EMA's review of this same evidence reached a different conclusion (see the Evidence Profile).