Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Serono's pivotal phase III trial, evaluating its recombinant human growth hormone in the treatment of HIV-associated adipose redistribution syndrome, has met all primary and major secondary endpoints.
Subscribe to our email newsletter
More than 300 patients enrolled in the trial to evaluate the efficacy of daily administration of the drug as treatment for the abnormal fat accumulation and distribution associated with HIV-associated adipose redistribution syndrome (HARS).
In the first phase of the study, patients were randomly assigned to receive either recombinant human growth hormone (r-hGH) 4 mg daily, or placebo. Growth hormone was administered for 12 weeks and all patients were measured by CT scan to determine changes in visceral adipose tissue (VAT) from baseline.
In the second placebo-controlled phase of the study, r-hGH was administered as 2 mg on alternate days for 24 weeks to assess the ability of a maintenance regimen to sustain improvements in VAT.
“The completion of this important research study of r-hGH in HARS is a strategic milestone for Serono and may lead to an important advance for patients living with this condition, that not only affects their health but also their quality of life,” said Dr Paul Lammers, chief medical officer at Serono.