Novo Nordisk registers Phase 3 CagriSema hypertension trial; posts results for two other studies

Novo Nordisk has three notable Phase 3 items on file: a newly registered trial and results postings for two previously reported studies.

• "REDEFINE" (NCT07919405), a Phase 3 trial of CagriSema in people with hypertension and obesity, was first posted on November 5, 2026 with status not yet recruiting. The study plans to enroll 1408 participants¹ and will test change in in-office systolic blood pressure from baseline to week 32 for CagriSema versus placebo¹ as a primary outcome.
• "Clarion-CKD" (NCT04968184), a Phase 3 trial of KBP-5074 in patients with uncontrolled hypertension and stage 3b/4 chronic kidney disease, was terminated (why stopped: Interim futility analysis showed primary endpoint not achieved)². The study was originally sponsored by KBP Biosciences PTE Ltd, but sponsorship was transferred to Novo Nordisk after the trial was terminated following the futility determination by IDMC², and results were first posted on November 4, 2026.
• "STEP HFpEF DM" (NCT04916470), a completed Phase 3 trial of semaglutide 2.4 mg once weekly in people with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, enrolled 617 participants³ and measured change in KCCQ Clinical Summary Score from baseline (week 0) to end of treatment (week 52)³ as a primary outcome, with results first posted on November 2, 2026.