This treatment is in clinical trials and has not been approved by the FDA or any regulatory authority. It is not available for prescription. Current stage: NDA filed with FDA (December 2025); under review. Estimated approval: Late 2026 to early 2027 (estimated — not confirmed) — subject to change.
CagriSema
Novo Nordisk · Code: Cagrilintide 2.4 mg + Semaglutide 2.4 mg
A fixed-dose combination of cagrilintide (a long-acting amylin analogue) and semaglutide 2.4 mg in a single weekly injection. Amylin is a hormone co-secreted with insulin that reduces appetite and slows gastric emptying — complementing GLP-1 action through a different pathway.
Quick read · 4 min
- •CagriSema is an investigational drug — it has not yet been approved by any regulatory authority
- •Best trial result so far: up to 22.7% average weight loss
- •Current stage: NDA filed with FDA (December 2025); under review
- •Expected approval: Late 2026 to early 2027 (estimated — not confirmed) — this is an estimate and not confirmed
Based on clinical trials · No rankings · Every claim linked to source
Last reviewed: April 2026
Why this matters:
Amylin is a natural hormone that, combined with GLP-1, may produce greater weight loss than either pathway alone. These treatments are still under investigation, and results in larger trials may differ from early data.
Development stage and timeline
Current stage:
Phase 3 complete. NDA filed with FDA December 2025. Under FDA review.
Next milestone:
FDA decision expected late 2026 to early 2027.
How it works
Cagrilintide acts on amylin receptors in the brain (particularly the area postrema) to reduce appetite and slow gastric emptying. Combined with semaglutide's GLP-1 receptor action, the two drugs reduce appetite through two distinct but complementary hormonal pathways — producing greater weight loss than semaglutide alone.
Phase 3 trial results
In the following Phase 3 trials, participants were randomly assigned to CagriSema or a dummy pill.
In the REDEFINE 1 trial, 20.4% average weight loss; 22.7% with full adherence. 50.7% reached a healthy BMI. 40.4% achieved ≥25% weight loss. GI side effects reported by 79.6% vs. 39.9% placebo.
In the REDEFINE 2 trial, 13.7% average weight loss; 15.7% with full adherence. Blood sugar (HbA1c) significantly reduced.
Side effects (early-stage data)
Frequencies from Phase 2 trial data. Final Phase 3 safety profile may differ.
Notable findings
- ✓20.4–22.7% weight loss — in the highest range of any drug so far (REDEFINE 1)
- ✓50.7% of participants reached a non-obese BMI in REDEFINE 1
- ✓40.4% achieved ≥25% weight loss in REDEFINE 1
- ✓Significant HbA1c improvement in people with type 2 diabetes (REDEFINE 2)
What this tends to offer vs. what it involves
What this tends to offer
- ✓20.4% average weight loss — between semaglutide and tirzepatide
- ✓Combines two natural hormone pathways into one injection
- ✓50.7% reached a healthy BMI in REDEFINE 1
- ✓Once-weekly injection
What this involves
- ◆GI side effects notably higher than semaglutide alone (nearly 80% experiencing some GI events)
- ◆Not yet approved — NDA filed December 2025, FDA decision pending
- ◆Two-drug combination may be more complex to manufacture
- ◆Price and insurance coverage unknown pending approval
Context: REDEFINE 1 results fell short of Novo Nordisk's internal target of ≥25% weight loss. The market reacted negatively. However, the 20.4–22.7% result still substantially outperforms semaglutide alone (14.9%) and cagrilintide alone (11.5%) in head-to-head comparisons.
Community insights
These are personal experiences shared in public online communities — not medical advice.
“The GI side effect rate (nearly 80% experiencing some GI events) is notably higher than semaglutide alone — worth discussing with your doctor before choosing this over tirzepatide.”
“Discussion centers on high GI side effect rates — nearly 8 in 10 participants experienced GI events vs. 4 in 10 with placebo.”
Sources & references
- [1]REDEFINE 13,417 adults with obesity, no type 2 diabetes · 68 weeks20.4% average weight loss; 22.7% with full adherence. About 1 in 2 participants reached a healthy BMI. GI side effects reported by about 4 in 5 participants on CagriSema vs. 2 in 5 on placebo.New England Journal of Medicine (2025) ↗
- [2]REDEFINE 21,206 adults with obesity and type 2 diabetes · 68 weeks13.7% weight loss (treatment policy); 15.7% with full adherence. Significant HbA1c reduction.New England Journal of Medicine (2025) ↗