GSK CMV vaccine trial posts results; six new studies span cardiovascular, MASH, CRSwNP

GSK posted a broad slate of registry updates this week, headlined by completed results from an early-stage CMV vaccine trial alongside multiple Phase 3 programs already recruiting.

• A Phase 1/2 first-in-human study of a candidate cytomegalovirus vaccine (NCT05089630) is now completed, with results first posted this week. The trial enrolled healthy adults 18 to 50 years of age, testing four dose levels of the vaccine administered in a step-wise dose escalation manner¹, with 333 participants (actual) enrolled¹.
• A Phase 2 study (NCT07712380) is not yet recruiting and will test whether adjuvanted RZV or adjuvanted RSVPreF3 vaccine can attenuate the progression of coronary plaque in adult individuals at risk for cardiovascular events², targeting 450 participants (estimated)² with primary completion estimated for May 2029.
• A Phase 1 relative bioavailability study of GSK5784283 (NCT07712393) is recruiting 24 participants (estimated)³ healthy volunteers to compare two subcutaneous formulations, with primary completion estimated for April 2027.
• Two Phase 3 trials of efimosfermin alfa in compensated cirrhosis due to MASH are recruiting: NEBULA-2 (NCT07704892), a 380 participants (estimated)⁴ two-part study with primary completion estimated October 2030, and NEBULA-1 (NCT07701993), a larger study enrolling 1740 participants (estimated)⁵ and measuring time from randomization to an adjudicated composite liver-related clinical outcome comprising all-cause mortality, liver transplantation, and occurrence of significant hepatic decompensation events⁵, with primary completion estimated June 2033.
• A Phase 4 single-arm study of depemokimab (NCT07701967) is recruiting 28 participants (estimated)⁶ in Japanese patients with chronic rhinosinusitis with nasal polyps, with primary completion estimated June 2027.