Ecnoglutide

Safety Summary

Across Phase 2 and Phase 3 injectable studies, most adverse events were transient mild-to-moderate gastrointestinal events. In Phase 2 (n=145), ecnoglutide-treated participants had diarrhea in 14.7%, nausea in 11.9%, constipation in 7.3%, decreased appetite in 6.4%, lipase increase in 5.5%, and hypoglycemia in 5.5% (mild, non-dose-dependent, mainly due to skipped meals), with no treatment-related grade 3 or higher adverse events and no treatment-related serious adverse events PMID 39333121. In EECOH-1 (Phase 3, n=211), TEAEs occurred in 78.3% (0.6 mg) and 77.5% (1.2 mg) vs. 63.4% placebo; no severe hypoglycemia, pancreatitis, or gallbladder-related disorders were reported PMID 41501026. In EECOH-2 (Phase 3, n=621), discontinuation due to adverse events was 3% (ecnoglutide 0.6 mg), 4% (1.2 mg), and 3% (dulaglutide) over 52 weeks PMID 40854315. In the SLIMMER obesity trial (Phase 3, n=664), TEAEs occurred in 93% of ecnoglutide-treated participants vs. 84% placebo; 10 ecnoglutide-treated participants discontinued due to adverse events; most common AEs were mild-to-moderate gastrointestinal events PMID 40555243. In Phase 1, adverse events included decreased appetite, nausea, and headache PMID 37364710. No signal of pancreatitis, severe hypoglycemia, or thyroid C-cell pathology has emerged across the clinical program.