Falutz 2007 (NEJM, n=412) randomized HIV patients with abdominal fat accumulation to 2 mg daily SC tesamorelin vs placebo for 26 weeks and showed selective visceral adipose tissue (VAT) reduction of approximately 15-18% vs no change in subcutaneous fat. This is the cleanest demonstration of selective visceral lipolysis by any pharmacologic agent and led to FDA approval in 2010 — the only peptide GHRH analog approved for an adult indication.
4 human studies · 4 animal studies
VAT reduction ~15-18% over 26 weeks in HIV-associated lipohypertrophy.
Subcutaneous fat unchanged — selective visceral effect.
FDA-approved 2010 for HIV-associated lipodystrophy (the only adult GHRH analog).
Effect reverses on discontinuation.
Top citations
Falutz 2007 — NEJM Phase 3
Falutz 2010 — Pooled Phase 3 with safety extension
Our take
Best-characterized GHRH analog with a real adult indication. The visceral selectivity is unusual and clinically meaningful.