Common questions
Is CagriSema FDA-approved?
No. As of June 2026, CagriSema is not FDA-approved. Novo Nordisk submitted a New Drug Application to the FDA on December 18, 2025, with FDA review expected during 2026. Until any approval is granted, CagriSema remains investigational and is not available as a prescription medication.
What is the CagriSema dose used in clinical trials?
The REDEFINE 1 and REDEFINE 2 Phase 3 trials used a once-weekly subcutaneous dose of cagrilintide 2.4 mg combined with semaglutide 2.4 mg, reached after roughly 16 weeks of dose titration. The titration started at 0.25 mg of each compound and stepped up every 4 weeks.
How much weight loss did CagriSema produce in REDEFINE 1?
In REDEFINE 1, adults with obesity or overweight (without diabetes) treated with CagriSema had a mean body weight reduction of 20.4% at 68 weeks under the treatment-policy estimand, compared with 3.0% on placebo. Under the trial-product estimand, the reduction was 22.7%.
What is the difference between the treatment-policy and trial-product estimands?
The treatment-policy estimand estimates the effect regardless of whether participants stayed on treatment or used rescue therapies. The trial-product estimand estimates the effect if participants stayed on treatment as intended. CagriSema's REDEFINE 1 result reads as 20.4% under treatment-policy or 22.7% under trial-product — they answer different questions.
How does CagriSema compare to tirzepatide?
Both produce large average weight loss in obesity. In a head-to-head open-label trial reported in February 2026, average weight loss at 84 weeks favored tirzepatide, and the sponsor noted CagriSema did not meet its prespecified non-inferiority target against tirzepatide. As of June 2026, tirzepatide is FDA-approved and CagriSema is not.
What are the most common CagriSema side effects?
Gastrointestinal events were the most common in both REDEFINE 1 and REDEFINE 2. In REDEFINE 1, GI events were reported in 79.6% of CagriSema participants versus 39.9% on placebo, including nausea (55%), constipation (30.7%), and vomiting (26.1%). Symptoms typically peaked during dose escalation and tapered during maintenance. Discontinuation due to adverse events was 5.9% in REDEFINE 1 and 8.4% in REDEFINE 2.
How long is a typical CagriSema research cycle?
REDEFINE 1 and REDEFINE 2 ran 68 weeks, with the first ~16 weeks dedicated to dose titration. Many research planning windows are shorter — 12 to 24 weeks is common for tolerability and titration assessment, with longer cycles for efficacy endpoints. Shorter cycles will see proportionally smaller weight-change endpoints than the full trial-length numbers.
Does CagriSema improve blood sugar in addition to weight?
Yes, in adults with type 2 diabetes. In REDEFINE 2, 73.5% of CagriSema participants reached HbA1c ≤6.5% versus 15.9% on placebo (treatment-policy estimand). Sponsor-reported REIMAGINE 2 data described an HbA1c reduction of 1.91 percentage points alongside 14.2% weight loss.