Peptide News Digest

#Six-Phase-3-Trials

2 stories

Clinical Trials · View digest

Amgen MariTide Switch Trial Continues Enrollment as Obesity Market Positions for 2027-2028 Monthly Injectable Launch

Amgen (NASDAQ: AMGN) continued enrollment through September 2026 in the dedicated MARITIME switch trial that specifically tests whether patients currently on weekly semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro, Zepbound) can be converted to monthly MariTide (maridebart cafraglutide, antibody-peptide conjugate combining GLP-1 receptor agonism with GIP receptor antagonism) with equivalent weight-loss maintenance and comparable tolerability. Filing for FDA approval is planned late 2026 to early 2027 with anticipated launch 2027-2028. Six total Phase 3 MariTide trials are enrolling across obesity (MARITIME-1), obesity plus type 2 diabetes (MARITIME-2), cardiovascular outcomes (MARITIME-CVD), heart failure (MARITIME-HF), obstructive sleep apnea (MARITIME-OSA), plus the switch trial. Cantor Fitzgerald analyst commentary earlier in 2026 had flagged a 4% bone mineral density decline signal from Phase 1 as a factor to watch; Phase 3 data on bone health will affect prescribing guidance especially for adults over 60 or with prior fracture history.

Industry · View digest

Amgen MariTide Consolidates as Sole Obesity Focus After AMG 513 Discontinuation; Late-Stage GLP-1-to-MariTide Switch Trial Underway

Amgen (NASDAQ: AMGN) continued through September 2026 the consolidation of its obesity portfolio around MariTide (maridebart cafraglutide, a monthly subcutaneous injectable antibody-peptide conjugate combining GLP-1 receptor agonist activity via the peptide component with GIP receptor antagonism via the antibody component) following the July 29, 2026 Q2 disclosure that Phase 1 AMG 513 development was halted. Amgen has launched a late-stage program specifically to test whether patients currently on weekly GLP-1 injections can be switched to monthly MariTide with equivalent efficacy and comparable tolerability — a differentiation strategy that uses the monthly dosing convenience as a switch driver rather than a first-line efficacy claim. Amgen expects to file for MariTide regulatory approval in late 2026 to early 2027. Six Phase 3 MariTide trials are enrolling across obesity, type 2 diabetes, heart failure, and obstructive sleep apnea. Cantor Fitzgerald analyst commentary earlier in 2026 had flagged a 4% bone mineral density decline signal from Phase 1 as a concern; Phase 3 data on bone health will factor into commercial positioning.