Phase III SURPASS-3 trial of LY 3298176 meets primary endpoints in type 2 diabetes.

The MRI (magnetic resonance imaging) sub-study achieved its primary and secondary endpoints. As evaluated by MRI scans, the sub-study showed all three doses of tirzepatide (5 mg, 10 mg, 15 mg) led to greater reductions in liver fat content compared to insulin degludec and reductions in volume of visceral adipose tissue and abdominal subcutaneous adipose tissue compared to increases in volume of both measurements with insulin degludec at 52 weeks.

Results among participants taking tirzepatide at 52 weeks showed: Greater absolute reduction from baseline in LFC for pooled 10 mg and 15 mg arms (-8.09% from 15.67% at baseline) compared to insulin degludec (-3.38% from 16.58% at baseline), the primary endpoint. -Greater relative reduction from baseline in LFC (29.78%-47.11% across the three doses) compared to 11.17% for insulin degludec. -The majority of participants taking tirzepatide achieved at least a 30% reduction in LFC from baseline (66.9%-81.4% across the three doses) compared to a third of those taking insulin degludec (32.12%). -Up to -1.65 liter (L) reduction from baseline of 6.81 L in VAT (15 mg) and -2.25 L reduction from baseline of 10.21 L in ASAT (10 mg) compared to an increase with insulin degludec (+0.38 L from 6.34 L baseline and +0.63 L from 10.04 L baseline respectively).

The overall safety profile of tirzepatide in SURPASS-3 was similar to the well-established GLP-1 receptor agonist class. Gastrointestinal side effects were the most commonly reported adverse events and decreased with continued dosing.The results were presented at the 57th European Association for the Study of Diabetes (EASD) Annual Meeting in an EASD-sponsored symposium.