The phase 2b, randomised, double-blind, placebo-controlled trial will enrol 150 patients with BMI between 30 and 60 kg/m2, and T2DM.
The trial will be conducted at 15 sites in Australia only and investigate 1.2 mg and 1.8 mg doses of beloranib twice weekly.
Primary endpoint is change in body weight after 12 months; secondary endpoints include change in glycaemic control.
Zafgen is pursuing a dual route to market for beloranib:
The primary focus is niche indications Prader-Willi Syndrome, where phase 3 recently begun, and obesity related to hypothalamic injury, currently in phase 2.
The secondary focus is on general obesity where the company now may target obese T2DM patients with the current phase 2b trial in Australia.
In a previous phase 2 in trial general obesity, 1.2 mg and 2.4 mg doses of beloranib produced 6.7% and 10.6% weight loss, respectively, after 12 weeks.
However, the 2.4 mg dose conferred tolerability issues and high withdrawal rates.
Whereas 2.4 mg is also tested in the ongoing phase 3 trial for PWS, it appears the company does not consider it suitable for general obesity in T2DM patients.