Obesity evidence dossier
CagriSema
CagriSema is the clearest near-term test of whether amylin plus GLP-1 can compete with tirzepatide and emerging triple agonists.
Total weight loss
20.4%
REDEFINE-1 · 2.4 mg / 2.4 mg · week 68 · Includes treatment stops
Placebo-adjusted
17.4%
Difference from placebo in the same study when reported.
Study context
Cagrilintide plus semaglutide/Adults with obesity or overweight, without diabetes/3417 participants across the study/68-week endpoint
Baseline: See the source for enrollment criteria
Ranked result & calculation
REDEFINE-1 · 2.4 mg / 2.4 mg · 68 weeks
Adults with obesity or overweight, without diabetes. 3,417 participants across the study (not this dose arm alone).
Includes treatment stops. Treatment-policy results estimate outcomes regardless of stopping treatment.
- Average weight loss
- 20.4%
- Placebo group
- 3% loss
- Beyond placebo
- 17.4 percentage points (arm subtraction)
- Stopped due to adverse events
- Not verified for this result
Score: 70% × 83.0 total-loss points + 30% × 80.6 beyond-placebo points = 82/100, rounded. Conversion scales
Alternative analysis assuming continued treatment: 22.7% total loss. This is not the result used for the headline score. Alternative analysis source ↗
Novo Nordisk, REDEFINE-1 ↗Phase 3 · Sponsor disclosure · Reviewed 2026-09-21
Evidence
Benchmark read
REDEFINE-1: Includes treatment stops.
Diabetes data
REDEFINE-2 studied people with type 2 diabetes and should be read separately from the non-diabetic obesity benchmark.
Safety
Side effects and cautions
Discontinuation read
Adverse-event discontinuation has not been verified for this result.
Common side effects
The late-stage program has emphasized gastrointestinal adverse events typical of incretin and amylin-based therapy.
Main cautions
Final label, dose flexibility, and discontinuation profile matter more than the headline weight-loss number alone.
Upcoming catalyst
What to watch next
Q4 2026Expected
Would the approved label and dosing support a competitive new injectable option?
Watch for: FDA decision, indicated population, dosing and safety language. This is Novo’s expected decision window, not a verified day-specific PDUFA date.
Source: Novo Nordisk, Q2 2026 presentation, slide 10Linked clinical trials
Trials in the saddl3 obesity snapshot
Non-diabetic obesity studies are prioritized; diabetes and healthy-volunteer studies remain visible and labeled.
NCT06780449
Phase 3
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
Novo Nordisk A/S
Non-diabetic obesity
Jan 20, 2026
NCT07011667
Phase 3
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Novo Nordisk A/S
Non-diabetic obesity
Dec 12, 2025
NCT06131437
Phase 3
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
Novo Nordisk A/S
Non-diabetic obesity
Feb 6, 2026
NCT07411560
Phase 1
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese
Novo Nordisk A/S
Non-diabetic obesity
Feb 17, 2026
NCT04940078
Phase 1
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
Novo Nordisk A/S
Non-diabetic obesity
Dec 12, 2025
NCT06716307
Phase 1
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
Novo Nordisk A/S
Non-diabetic obesity
Aug 27, 2025
NCT06388187
Phase 3
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
Novo Nordisk A/S
Other obesity study
Mar 30, 2026
NCT05567796
Phase 3
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Novo Nordisk A/S
Other obesity study
Mar 30, 2026
NCT07253285
Phase 3
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk A/S
Other obesity study
Apr 2, 2026
NCT07357766
Phase 3
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk A/S
Other obesity study
Feb 25, 2026
NCT05394519
Phase 3
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Novo Nordisk A/S
Type 2 diabetes / obesity
Jan 28, 2026
NCT05813925
Phase 3
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
Novo Nordisk A/S
Other obesity study
Jan 22, 2026