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www.fdanews.com/articles/109179-theratechnologies-drug-meets-body-image-endpoints-in-hiv-trials

Theratechnologies Drug Meets Body Image Endpoints in HIV Trials

August 5, 2008

Theratechnologies’ drug tesamorelin met endpoints in the company’s first and confirmatory Phase III clinical trials for patients with HIV-associated lipodystrophy.

Caused by several factors, including an antiviral drug regimen and the virus itself, HIV-associated lipodystrophy is characterized by body composition changes, dyslipidemia and glucose intolerance. The condition can stigmatize patients and discourage them from continuing treatment, according to the company.

In the first trial, patients at 52 weeks experienced sustained improvements in belly and body appearance distress, the study’s primary endpoint. In the confirmatory trial, improvements were seen in belly image and triglyceride levels.