A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks in HIV Infected Patients With HIV Associated Visceral Obesity
This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC 1295 or placebo.
The objective is to assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated visceral obesity.
Inclusion Criteria: Age 18-65 on stable antiviral regimen Documented HIV infection HIV associated visceral obesity Body mass index (BMI) > 24 and < 30 kg/m2 Exclusion Criteria: Diabetes Use of growth hormone (GH) or other GH secretagogues Use of systemic glucocorticoids, Use of megestrol acetate or other appetite stimulants, Use of general anorexigenic or weight-reducing agents, or Use of androgens, other than testosterone replacement therapy for male hypogonadism at physiological doses and on a stable regimen for at least 6 months prior to randomization.