Investigational — not approved or available to prescribe.
Main trial result
22.7%
Stage
FDA review
Timeline (not confirmed)
Late 2026 to early 2027 (estimated — not confirmed)
Form
Weekly injection
What it is
A fixed-dose combination of cagrilintide and semaglutide 2.4 mg in a single weekly injection. Cagrilintide is a long-acting amylin analogue: a man-made copy of the hormone amylin. The body releases amylin alongside insulin, and it reduces appetite and slows gastric emptying. So it adds to what GLP-1 does, by a different route.
Why this matters:
Amylin is a natural hormone. Combined with GLP-1, it 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. The new drug application (NDA) was filed with the FDA in December 2025. It is under FDA review.
Next milestone:
FDA decision expected late 2026 to early 2027.
How it works
Cagrilintide acts on amylin receptors in the brain, above all in a region called the area postrema. That reduces appetite and slows gastric emptying — how fast the stomach empties. Semaglutide acts on the GLP-1 receptor. Together the two drugs cut appetite through two separate hormone pathways that complement each other. The result is greater weight loss than semaglutide alone.
Timeline note: In Phase 3, weight kept falling throughout the 68-week trial
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 people in the trial reached a non-obese BMI (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
- Gut side effects notably higher than semaglutide alone (nearly 80% had some GI event)
- 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, and the market reacted badly. Even so, 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 gut side effect rate is notably higher than semaglutide alone: nearly 80% had some GI event. Worth discussing with your doctor before choosing this over tirzepatide.”
“Discussion centres on the high gut side effect rates: nearly 8 in 10 people in the trial had GI events, vs. 4 in 10 on 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) ↗