Cagrilintide
InvestigationalA long-acting amylin analog developed by Novo Nordisk for weight management. Studied in Phase 3 trials as CagriSema (combination with semaglutide). The Phase 3 REDEFINE 1 trial showed -20.4% weight loss with cagrilintide-semaglutide versus -3.0% with placebo at 68 weeks.
AM833 · NN9838
18 human studies
- Preclinical
- 36%
- Clinical
- 64%
Based on 28 cited sources
clinically demonstrated · high confidence
Demonstrated effect magnitude — not a recommendation or safety claim.
Research Depth: multiple large placebo-controlled RCTs incl. Phase 3 REDEFINE 1 (n=3,417) and REDEFINE 2, total human N well over 1,000, no published meta-analysis yet. Mechanism: amylin AMY1/2/3 receptors named with binding + functional confirmation and characterized satiety pathway. Plausibility: full mechanism to weight-loss outcome chain supported, coherent with amylin biology and same-class pramlintide. Global Coverage: international multi-country trials but single sponsor (Novo Nordisk) and FDA review pending, limiting independence. Community Experience: trial-only, near-negligible real-world usage signal. Effectiveness basis clinical: REDEFINE 1 (NCT05567796) showed -20.4% weight loss with cagrilintide-semaglutide versus -3.0% with placebo at 68 weeks. Reconciliation (2026-06-27): citation sweep corrected REDEFINE 1 from "~22.7% with head-to-head superiority over semaglutide" to "-20.4% vs -3.0% placebo" — a placebo-controlled (not head-to-head) result; Effectiveness lowered 93 -> 84 (E4 drops from head-to-head-superiority to placebo-superiority; large magnitude E1/E2 retained). Evidence axis unchanged (trial counts/tiers and mechanism intact).
Cagrilintide is a long-acting amylin analog that acts through distinct and complementary pathways to GLP-1 agonists. Human clinical trial data supports its efficacy for weight management.
How It Works (Simplified)
Cagrilintide mimics amylin, a hormone co-secreted with insulin that signals satiety through different brain pathways than GLP-1:
Activates amylin receptors in the area postrema, sending powerful “full” signals to the brain through a different pathway than GLP-1.
Restores responsiveness to leptin, the body’s natural “stop eating” hormone that becomes impaired in obesity.
Delays gastric emptying, prolonging feelings of fullness and preventing rapid blood sugar spikes after meals.
Key Research: Lau DCW et al. (2021) demonstrated -10.8% weight loss with cagrilintide 4.5 mg monotherapy in Phase 2 RCT. PMID:34798060
Important Limitations
- Cagrilintide is an investigational compound with no regulatory approvals
- All efficacy data from Phase 1b and Phase 2 trials; Phase 3 results pending
- No long-term safety data beyond 1 year
- No cardiovascular outcomes data (REDEFINE CVOT ongoing, results 2029)
- All clinical trials sponsored by Novo Nordisk (developer)
- Not available outside of clinical trials as of January 2026
Research Tools
- Cagrilintide Reconstitution Calculator — calculate concentration from vial mass and diluent volume (educational tool only)
| NCT ID | Title | Peptide | Phase | Status | Completion |
|---|---|---|---|---|---|
| NCT03856047 | Phase 2 Cagrilintide Monotherapy for Weight Management | Cagrilintide | Phase 2 | Completed | Jan 2020 |
| NCT04163354 | Phase 1b Cagrilintide + Semaglutide Combination PK/PD | Cagrilintide | Phase 1 | Completed | Jan 2020 |
| NCT04940078 | Phase 2 CagriSema in Type 2 Diabetes | Cagrilintide | Phase 2 | Completed | Jan 2022 |
| NCT05567796 | REDEFINE 1: CagriSema vs Semaglutide in Obesity Obesity | Cagrilintide | Phase 3 | Active | Oct 2024 |
| NCT05394519 | REDEFINE 2: CagriSema in Obesity with T2D Overweight, Obesity +1 more | Cagrilintide | Phase 3 | Completed | Jan 2025 |
| NCT06024720 | REDEFINE 3: CagriSema vs Tirzepatide | Cagrilintide | Phase 3 | Active | - |
| NCT05803421 | REDEFINE CVOT: CagriSema Cardiovascular Outcomes | Cagrilintide | Phase 3 | Recruiting | - |
| NCT07357740 | A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes Diabetes Mellitus, Type 2 | Cagrilintide | Phase 2 | Not yet recruiting | Aug 2027 |
| NCT07282613 | A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes Diabetes Mellitus, Type 2 | Cagrilintide | Phase 3 | Not yet recruiting | Sep 2029 |
| NCT07589686 | A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight Obesity or Overweight | Cagrilintide | Phase 2 | Not yet recruiting | Nov 2027 |
| NCT07357766 | A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight Overweight, Obesity | Cagrilintide | Phase 3 | Not yet recruiting | Nov 2027 |
| NCT07564414 | A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight Obesity, Type 2 Diabetes | Cagrilintide | Phase 3 | Recruiting | Feb 2028 |
| NCT07253285 | A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Overweight, Obesity | Cagrilintide | Phase 3 | Recruiting | Mar 2030 |
| NCT07220642 | Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide Obesity, Overweight | Cagrilintide | Phase 3 | Active | May 2027 |
| NCT07220759 | Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide Overweight, Obesity +1 more | Cagrilintide | Phase 3 | Active | May 2027 |
| NCT07011667 | A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term Obesity | Cagrilintide | Phase 3 | Active | Mar 2027 |
| NCT06926842 | Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2) Overweight, Type 2 Diabetes +1 more | Cagrilintide | Phase 2 | Active | Aug 2026 |
| NCT06951854 | Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder Autism Spectrum Disorder (ASD | Cagrilintide | Phase 2 | Recruiting | Sep 2025 |
| NCT06780449 | A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity Obesity | Cagrilintide | Phase 3 | Active | Aug 2028 |
| NCT06797869 | A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy | Cagrilintide | Phase 2 | Active | Aug 2026 |
| NCT06534411 | A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both Diabetes Mellitus, Type 2 | Cagrilintide | Phase 3 | Active | Jun 2026 |
Phase 2 Cagrilintide Monotherapy for Weight Management
Phase 1b Cagrilintide + Semaglutide Combination PK/PD
REDEFINE 1: CagriSema vs Semaglutide in Obesity
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Initial titration period with dose escalation. Appetite suppression begins within days. GI side effects (nausea, vomiting) most common during this phase. Weight loss typically begins but is modest during titration.
PMID:34798060Continued weight loss as maintenance dose is reached. Mean weight loss of approximately 5-7% expected by week 12 based on Phase 2 trajectory. GI side effects typically improve after titration completion.
PMID:34798060Ongoing weight loss approaching plateau. Phase 2 monotherapy showed -10.8% at 26 weeks with cagrilintide 4.5 mg. Combination with semaglutide showed -17.1% at 20 weeks, projecting to greater efficacy with longer treatment.
PMID:33894838Long-term maintenance phase. Phase 3 trials (REDEFINE) are 68 weeks duration. Weight loss plateau expected around week 40-68 based on GLP-1 agonist class data. Long-term efficacy and durability under investigation.
Research-based observations
This timeline reflects observations from published clinical and preclinical studies. Individual responses may vary significantly. This is not a guarantee of effects or a dosing schedule. Consult qualified healthcare providers for personalized guidance.
Good Signs (5 indicators)
Warning Signs (4 indicators)
Bad Signs (5 indicators)
For Research Evaluation Only
These quality indicators are general guidelines based on typical peptide characteristics. Professional laboratory testing (HPLC, mass spectrometry) provides definitive quality verification. This checklist is for initial visual evaluation only.
Semaglutide
SynergisticCagriSema is the combination product of cagrilintide + semaglutide. Phase 2 data shows -15.6% weight loss vs -5.1% for semaglutide alone. Complementary mechanisms via amylin and GLP-1 pathways.
Liraglutide
CompatibleCagrilintide monotherapy showed comparable efficacy to liraglutide 3.0 mg in Phase 2. No specific interaction data but both can reduce appetite and slow gastric emptying.
Tirzepatide
CautionBoth are potent weight loss agents targeting distinct pathways. No combination studies exist. Concurrent use would have unknown safety profile and unclear benefit given overlapping GLP-1 receptor activity.
Research Note: Interaction data is based on published literature, mechanistic understanding, and theoretical considerations. Most peptide combinations lack direct clinical study. This information is for educational purposes only and does not constitute medical advice. Always consult qualified healthcare providers.
Key Studies Cited
Full reference list available on request. All citations link to PubMed for verification.
This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength ratings follow a modified GRADE approach.
For complete methodology details, see our Methodology page.
Important Disclaimer
This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.
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