Theratechnologies Presents Results Of Phase 3 Clinical Trials For Tesamorelin

Theratechnologies has presented the results from both its Phase 3 clinical trials evaluating Tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. In addition, Theratechnologies will also sponsor a symposium entitled ‘Lipohypertrophy: Beyond Body Image’, at the Conference.

The pooled data from both Phase 3 clinical trials has demonstrated that treatment with 2mg Tesamorelin daily for 26 weeks resulted in significant visceral adipose tissue (VAT) decrease in Tesamorelin-treated patients after 26 weeks of treatment (-13.1 more or less 21.1% p less than 0.001 vs placebo).

It also demonstrated that there are no clinically significant changes in limb fat (0.2 more or less 13.2%, p=0.001 vs placebo) and in abdominal subcutaneous adipose tissue (SAT) (0.7 more or less 15.5%, p=0.08 vs placebo) but significant decrease in triglycerides (-0.4 more or less 1.6 mmol/L, p less than 0.001 vs placebo) was observed.

During the study at Week 52, improvements in VAT and triglycerides observed at Week 26 were sustained in the group of patients who received tesamorelin over 52 weeks (-17.5 more or less 23.3% and -0.5 more or less 2.0 mmol/L, respectively, p less than 0.001 vs baseline).

Patients who were switched from tesamorelin to placebo treatment at Week 26, per the study design, regained VAT at Week 52 (0.3 more or less 26.3%, p=0.18 vs baseline). No clinically important changes in glucose parameters were observed after treatment with tesamorelin at both Weeks 26 and 52.