Falutz 2007 — NEJM Pivotal Phase 3 Tesamorelin

New England Journal of Medicine·December 6, 2007

J. Falutz, S. Allas, K. Blot, D. Potvin, D. Kotler, M. Somero, D. Berger, S. Brown, G. Richmond, J. Fessel, R. Turner, S. Grinspoon

Summary

Tesamorelin selectively reduced visceral fat by ~15% over 26 weeks with improvements in dyslipidemia, without significant adverse effects on glycemic measures.

Study Details

Study Design

Phase 3 randomized, double-blind, placebo-controlled trial

Indication

HIV-associated lipodystrophy

Intervention

Tesamorelin 2 mg SC daily

Species

Human

Sample Size

412 subjects

Risk of Bias Assessment

Industry-funded (Theratechnologies)