Regeneron registers Phase 3 LINKER-AL1 trial of linvoseltamab for AL amyloidosis

Regeneron Pharmaceuticals posted a new Phase 3 registration this week and saw updates across several other listed trials.

• Regeneron registered "LINKER-AL1" (NCT07901725), a Phase 3 trial comparing linvoseltamab to Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-VCd) in adults newly diagnosed with systemic light chain amyloidosis. The study is researching Regeneron drug linvoseltamab alone compared to a standard of care combination to see if it can help treat participants who are newly diagnosed and previously untreated for systemic amyloid light-chain (AL) amyloidosis.¹ The trial is listed as not yet recruiting, with enrollment estimated at 382 participants.¹
• The Phase 1 trial of REGN17235 (NCT07753148) in CCUS and low-risk MDS with an SF3B1 mutation is now listed as recruiting, with its last update posted October 27, 2026. Key inclusion criteria require presence of the SF3B1 mutation in bone marrow or peripheral blood along with a diagnosis of low-risk MDS or CCUS per WHO 2022 criteria.² Recruitment continues at two sites in Belgium, Uz Ghent in Ghent and Algemeen Ziekenhuis (AZ) Delta in Roeselare.
• The Phase 3 "RISE-1" trial (NCT07896265) of olatorepatide in overweight or obesity without diabetes remains not yet recruiting. The study will test olatorepatide to determine whether it can help treat overweight or obesity.³ It will compare how safe and well olatorepatide, a GLP-1/GIP receptor agonist, works against placebo, with enrollment estimated at 3000 participants.³
• The observational "CEMI-LUNG" study of cemiplimab in advanced NSCLC (NCT05363319) remains active but not recruiting, with its last update posted October 30, 2026. Enrollment is listed at 509 participants.⁴
• A Sanofi-sponsored Phase 1 study (NCT07646548) comparing subcutaneous dupilumab coformulated with berahyaluronidase alfa against dupilumab alone in healthy volunteers is now listed as completed. Regeneron Pharmaceuticals is named as a collaborator, and the trial enrolled 40 participants.⁵
• A Sanofi-sponsored Phase IV trial of Dupixent in Indian adults with moderate-to-severe atopic dermatitis (NCT07905547) remains not yet recruiting. Regeneron Pharmaceuticals is listed as a collaborator, and the study will describe the safety of dupilumab in adult participants with atopic dermatitis⁶, with enrollment estimated at 56 participants.