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Results from the 26-week confirmatory, phase 3 trial of tesamorelin (TH9507), a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation: a multicenter, double-blind, placebo-controlled study with 404 randomized patients

J. Falutz1, C. Marsolais2, S. Allas2, D. Potvin2, J.-C. Mamputu2, M. Zoltowska2, D. Berger3, M. Somero4, G. Moyle5, S. Brown6, C. Martorell7, R. Turner8, S. Grinspoon9

1Montreal General Hospital, McGill University Health Centre, Montreal, Canada, 2Theratechnologies Inc., Montreal, Canada, 3Northstar Health Care, Chicago, United States, 4Private, Palm Spring, United States, 5Chelsea and Wesminster Hospital, London, United Kingdom, 6AIDS Research Alliance, West Hollywood, United States, 7The Research Institute, Springfield, United States, 8Phase V Technologies Inc., Wellesley, United States, 9Massachusetts General Hospital and Harvard Medical School, Boston, United States

Background: HIV patients receiving antiretroviral therapy (ART) often show increased visceral adipose tissue (VAT), a known cardiovascular risk factor. Excess VAT may have a negative impact on body image, resulting in non-adherence to ART. Treatment with tesamorelin was overall well tolerated and resulted in sustained VAT loss in the first Phase 3 trial in HIV patients. Here are presented key 26-week results of the confirmatory trial.
Methods: HIV patients (84% male) with evidence of abdominal fat accumulation in the context of ART were randomized to 2 mg tesamorelin (n=275) or placebo (n=129) s.c. daily for 26 weeks. The primary endpoint was the percent change in VAT. Secondary endpoints included patient-reported outcomes related to body image, triglycerides, total cholesterol/HDL ratio, IGF-I, and safety.
Results: Baseline age was 48±8 (mean±SD) years and waist circumference 105±9 cm. At Week 26, VAT significantly decreased in tesamorelin-treated patients over placebo (-10.9±21.2 vs. -0.6±18.9%, P<0.001). Changes in abdominal SAT were not significantly different between groups (1.1±15.2 vs. 0.9±15.8%, tesamorelin vs. placebo, P=0.55). Treatment with tesamorelin was associated with significant improvements in belly appearance distress (P=0.022 vs. placebo) and physician-reported belly profile (P=0.021 vs. placebo). A trend for improvement in triglycerides was observed in tesamorelin-treated patients (change from baseline: -0.25±1.48 vs. 0.04±1.20 mmol/L, tesamorelin vs. placebo, P=0.08 vs. placebo and P=0.01 vs. baseline), while no significant changes were observed in the total cholesterol/HDL ratio. Mean IGF-I level increased within the physiological range in tesamorelin-treated patients (change from baseline: 106±110 ng/mL, P<0.001 vs. placebo). Finally, treatment was overall well tolerated, with no significant changes in glucose parameters.
Conclusions: These data confirm that daily administration of 2 mg tesamorelin for 26 weeks to HIV patients with abdominal fat accumulation is overall well tolerated, preferentially decreases VAT, and improves belly image, which may have important implications for HIV treatment outcomes.

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