Zafgen announced data for the second cohort of its Phase 2 clinical trial of ZGN-1061, designed to evaluate efficacy and safety in patients with type 2 diabetes and the likely therapeutic dose range of ZGN-1061 up to 1.8 mg. The clinical trial met all of its primary objectives at the 1.8 mg dose, which included glycemic control, or change in A1C, and safety and tolerability. The 12-week data demonstrated that treatment with the 1.8 mg dose of ZGN-1061 produced substantially more improvement in A1C than the 0.9 mg dose. Progressive and notable reduction in body weight also occurred in patients treated with the 1.8 mg dose. The data showed a favorable safety and tolerability profile for ZGN-1061, with no treatment-related serious adverse events and no cardiovascular safety signals observed. Treatment with ZGN-1061 demonstrated a statistically significant reduction in A1C for 0.9 mg and 1.8 mg versus placebo at Week 12, with a 1.1% reduction in A1C at the 1.8 mg dose relative to placebo. A1C levels continued to decline with no waning of effect for both doses through Week 12. Progressive weight reduction was also observed at the 1.8 mg dose, with placebo-corrected weight loss of 2.3 kg seen at Week 12 with no evidence of waning effect. Significant improvements were observed across multiple secondary efficacy endpoints and various relevant metabolic biomarkers, as well.
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