Zafgen, a biotechnology company developing treatments for obesity and complex metabolic disorders, recently announced the completion of patient recruitment for ZAF-203, a Phase 2b clinical trial for beloranib, a therapy targeting patients with both severe obesity and type 2 diabetes. The trial has enrolled a total of 152 patients across 16 sites in Australia.
ZAF-203 is designed to investigate the long-term weight loss effects of the MetAP2 inhibitor beloranib in patients with severe obesity that is complicated by type 2 diabetes. The drug is a novel, injectable, small molecule aimed at reducing hunger and using stored body fat as a source of energy. It does so by inhibiting the MetAP2 enzyme from releasing signals that drive lipid synthesis by the liver and storage of fat throughout the body. As a result, more fat is metabolized, which helps in weight loss.
The trial will run for 12 months, with an interim six-month analysis. The company is expected to release this six-month interim data on a total of 95 patients by late 2015 or early 2016. The baseline characteristics of the study population on average are as follows: 54 years of age, body mass index (BMI) of 40 kg/m2, body weight of 115 kg, HbA1c of 8.3% and fasting glucose of 193 mg/dl, with 43% of the patients being female. The patients will receive twice weekly injections of either a placebo, or 1.2 or 1.8 mg of the drug during this 12 month period. The primary efficacy endpoint of the study is to measure the change in total body weight at six months of randomized treatment. Key secondary endpoints include changes in glycemic control, lipid parameters and inflammatory markers. Additional assessments include sense of hunger and quality of life impact for patients.
Speaking about the study, Dr. Thomas Hughes, Chief Executive Officer of Zafgen, noted, “We’re very pleased to announce that we have completed enrolment for our Phase 2b study in this high risk population of obese patients complicated by type 2 diabetes inadequately controlled by other agents. We look forward to seeing the impact of beloranib treatment on body weight and glycemic control, among other endpoints. This study provides our first view of the drug’s potential to provide changes in the range of those seen following bariatric surgery.”