Business Context and Reporting Period
Company: Novo Nordisk A/S
Filing Type: Form 6-K (Report of Foreign Private Issuer)
Date: February 2, 2026
Subject: Announcement of headline results from the REIMAGINE 2 Phase 3 clinical trial for CagriSema in adults with type 2 diabetes.
Key Financial Metrics
This filing is a clinical trial update and does not contain financial statements, revenue, profit, cash flow, margin, debt, or liquidity data. The filing text does not provide a clear value for any financial metric.
Material Changes and Clinical Results
The filing reports superior efficacy for CagriSema (a fixed-dose combination of cagrilintide and semaglutide) compared to semaglutide monotherapy in the REIMAGINE 2 trial (2,728 participants, 68 weeks).
- HbA1c Reduction (Efficacy Estimand): CagriSema 2.4 mg/2.4 mg achieved a reduction of 1.91% points versus 1.76% points for semaglutide 2.4 mg (baseline 8.2%).
- Weight Loss (Efficacy Estimand): CagriSema 2.4 mg/2.4 mg achieved 14.2% weight loss versus 10.2% for semaglutide 2.4 mg (baseline 101 kg). No weight loss plateau was observed at week 68.
- Weight Loss Thresholds: 43% of CagriSema-treated patients achieved ≥15% weight loss; 24% achieved ≥20% weight loss.
- Treatment-Regimen Estimand: CagriSema showed 1.80% HbA1c reduction and 12.9% weight loss versus 1.68% and 9.2% for semaglutide, respectively.
- Safety: Profile was safe and well-tolerated; most common adverse events were gastrointestinal, mild to moderate, and diminished over time.
Guidance, Outlook, and Management Commentary
Management Commentary: Martin Holst Lange, Executive Vice President and Chief Scientific Officer, stated the results confirm strong weight loss data and demonstrate superior outcomes in blood glucose control and weight reduction compared to individual therapies. He expressed belief that CagriSema could be the first amylin-based combination therapy for type 2 diabetes with a focus on weight loss.
Regulatory Outlook:
- Novo Nordisk will approach authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes following REIMAGINE 1 and REIMAGINE 2 results.
- CagriSema for weight management was submitted to the US FDA in December 2025 based on REDEFINE 1 and REDEFINE 2 trials.
- Detailed REIMAGINE 2 results will be presented at a scientific conference in 2026.
Risks and Contingencies: The filing notes that adverse events were consistent with incretin and amylin-based therapies. No specific financial risks or contingencies were disclosed in this text.
Investor Verification Checklist
- Verify the regulatory timeline for CagriSema approval in type 2 diabetes following the upcoming discussions with authorities.
- Monitor the presentation of detailed REIMAGINE 2 results at the 2026 scientific conference for full safety and efficacy data.
- Track the status of the CagriSema weight management submission to the US FDA (submitted Dec 2025).
- Review upcoming results from REIMAGINE 4 and REIMAGINE 5, which compare CagriSema against tirzepatide.
- Assess the potential market impact of CagriSema as a dual-agonist therapy against existing GLP-1 competitors.