Peptide Name
Cagrilintide
Updated March 2026
Cagrilintide Dosing Protocol
Complete cagrilintide research protocol reference covering titration schedules, reconstitution math, half-life, side effect profile, and clinical trial outcomes.
Half-life
159-195 hours (~7-8 days)
Dose range
0.25-4.5 mg weekly
Status
Investigational, Phase 3
Developer
Novo Nordisk
Need to calculate reconstitution and dosing units? Use the calculate injection units.
Quick Reference Card
Aliases
AM833, NN9838
Category / Class
Long-Acting Amylin Analogue / Dual Amylin & Calcitonin Receptor Agonist (DACRA)
Half-Life
159-195 hours (~7-8 days)
Dosing Frequency
Once weekly
Dose Range
0.25-4.5 mg/week (monotherapy); 0.25-2.4 mg/week (CagriSema combination)
Common Vial Sizes
5 mg, 10 mg
Route of Administration
Subcutaneous injection
Regulatory Status
Investigational - Phase 3 (NDA filed December 2025; FDA decision anticipated late 2026)
Developer
Novo Nordisk
Key Stat
11.8% mean body-weight reduction as monotherapy at 68 weeks (REDEFINE 1); 20.4% when combined with semaglutide as CagriSema.
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What Is Cagrilintide?
Cagrilintide is a long-acting amylin analogue developed by Novo Nordisk for obesity and type 2 diabetes programs. Also known as AM833 and NN9838, it belongs to the dual amylin and calcitonin receptor agonist (DACRA) class, a pathway distinct from GLP-1 receptor agonists such as semaglutide and tirzepatide.
Structurally, cagrilintide is based on the human amylin backbone with calcitonin-inspired optimization. Reported modifications include substitutions that reduce fibrillation risk, a C-terminal proline substitution, and an N-terminal C20 fatty diacid enabling reversible albumin binding. This supports a plasma half-life in the ~7-8 day range and once-weekly dosing.
Cagrilintide is being investigated both as monotherapy (RENEW program) and in fixed-dose combination with semaglutide 2.4 mg (CagriSema; REDEFINE and REIMAGINE programs). In REDEFINE 1, cagrilintide monotherapy produced 11.8% mean weight loss at 68 weeks, while CagriSema achieved 20.4%. Novo Nordisk filed an NDA for CagriSema in December 2025, with a regulatory decision anticipated by late 2026.
This compound is investigational and not FDA-approved. All information on this page is for educational and research reference purposes only.
How Cagrilintide Works: Dual Amylin & Calcitonin Receptor Activation
Cagrilintide's mechanism combines central satiety signaling with peripheral gastric and metabolic effects through amylin receptor subtypes and calcitonin receptor activity.
Amylin Receptors (AMY1R, AMY2R, AMY3R) - Satiety Signaling & Appetite Suppression
Amylin receptors are calcitonin receptor complexes with RAMP1/2/3 and are prominent in the area postrema and hypothalamus. Cagrilintide activation enhances satiety signaling and lowers food intake. Preclinical findings cited in the guide indicate AMY1R/AMY3R relevance for weight-response effects, with preserved lean-mass profile during weight reduction.
Calcitonin Receptor (CTR) - Gastric Emptying & Glucagon Suppression
CTR activity contributes to delayed gastric emptying and prolonged post-meal fullness. It is also linked to postprandial glucagon suppression and improved glycemic handling. Energy-expenditure contributions are being explored but remain less defined in humans.
Combined Pathway Summary
Non-selective agonism across amylin receptor subtypes plus CTR creates a multi-layered profile: central appetite suppression, peripheral gastric emptying delay, and glucagon modulation. This profile is complementary to GLP-1 agonism, helping explain additive outcomes in cagrilintide + semaglutide (CagriSema) studies.
In REDEFINE 1, CagriSema (20.4% mean weight loss) outperformed cagrilintide monotherapy (11.8%) and semaglutide monotherapy (14.9%), supporting an additive amylin + GLP-1 pharmacology model.
Tools for this Protocol
- Pep Pal calculator for reconstitution and units.
- peptide reconstitution calculator to lock in syringe draw volume.
Cagrilintide Dosing Protocol & Titration Schedule
Monotherapy - Initiation
1-2
0.6 mg weekly
Assess GI tolerability; inject on the same day each week.
Monotherapy - Early Escalation
3-4
1.2 mg weekly
Double from initiation; monitor nausea and GI burden.
Monotherapy - Mid Escalation
5-6
2.4 mg weekly
Therapeutic range used in combination protocols.
Monotherapy - Maximum Dose
7+
4.5 mg weekly
Highest studied monotherapy dose; maintain as tolerated.
CagriSema - Initiation
1-4
0.25 mg weekly
Co-escalated with semaglutide 0.25 mg.
CagriSema - Early Escalation
5-8
0.5 mg weekly
Matched escalation with semaglutide.
CagriSema - Mid Escalation
9-12
1.0 mg weekly
GI effects often peak during this phase.
CagriSema - Late Escalation
13-16
1.7 mg weekly
Approaching maintenance; reassess tolerance.
CagriSema - Maintenance
17+
2.4 mg weekly
Target maintenance dose in REDEFINE/REIMAGINE programs.
Important Titration Notes
Why pacing matters: Phase 2 data reported dose-dependent GI adverse events; 4-week escalation intervals are used to reduce early-intolerance risk.
Dose flexibility: Phase 2 studied 0.3-4.5 mg monotherapy. CagriSema programs centered on 2.4 mg cagrilintide with semaglutide.
Missed dose guidance: With a ~7-8 day half-life, administer the missed dose if the next scheduled dose is more than 3 days away; otherwise skip and resume schedule. Do not double dose.
Phase 3 context: REDEFINE/REIMAGINE standardized 16-week escalation to 2.4 mg/week for combination regimens, while RENEW is evaluating monotherapy.
Cagrilintide Reconstitution Guide
Vial Size: 5 mg
BAC Water: 2.0 mL
Concentration: 2,500 mcg/mL (2.5 mg/mL)
0.6 mg: 0.24 mL / 24 units
1.2 mg: 0.48 mL / 48 units
2.4 mg: 0.96 mL / 96 units
4.5 mg: 1.80 mL / 180 units*
Vial Size: 5 mg
BAC Water: 3.0 mL
Concentration: 1,670 mcg/mL (1.67 mg/mL)
0.6 mg: 0.36 mL / 36 units
1.2 mg: 0.72 mL / 72 units
2.4 mg: 1.44 mL / 144 units*
4.5 mg: N/A - exceeds vial
Vial Size: 10 mg
BAC Water: 3.0 mL
Concentration: 3,330 mcg/mL (3.33 mg/mL)
0.6 mg: 0.18 mL / 18 units
1.2 mg: 0.36 mL / 36 units
2.4 mg: 0.72 mL / 72 units
4.5 mg: 1.35 mL / 135 units*
Vial Size: 10 mg
BAC Water: 2.0 mL
Concentration: 5,000 mcg/mL (5.0 mg/mL)
0.6 mg: 0.12 mL / 12 units
1.2 mg: 0.24 mL / 24 units
2.4 mg: 0.48 mL / 48 units
4.5 mg: 0.90 mL / 90 units
7-Step Reconstitution Instructions
- Remove the lyophilized cagrilintide vial from freezer storage and allow it to reach room temperature for about 10-15 minutes. Do not heat.
- Clean the vial stopper with an alcohol swab and allow it to air dry completely.
- Using a sterile syringe, draw the desired volume of bacteriostatic water.
- Insert the needle at an angle and inject the BAC water slowly down the inside wall of the vial. Do not spray directly onto powder.
- Gently swirl or roll the vial until fully dissolved to a clear solution. Do not shake.
- Inspect for clarity. Discard if cloudy, discolored, or if particulates are visible.
- Label with reconstitution date and concentration, refrigerate immediately at 2-8C, and use within 28-30 days.
Cagrilintide Side Effects - What Clinical Trials Show
Gastrointestinal effects are the most frequent adverse events with cagrilintide and show dose dependence across phase 2 and phase 3 datasets.
Common gastrointestinal side effects: Phase 2 reported GI adverse events in 41-63% of cagrilintide groups vs 32% placebo, with nausea as the most frequent event; REDEFINE 1 reported higher GI event rates in CagriSema versus placebo.
Injection-site reactions: Injection-site reactions were more frequent in cagrilintide-containing arms than semaglutide alone, typically mild and self-limited.
Antibody formation: Anti-cagrilintide antibodies were observed in a minority during extended treatment, without clear efficacy or safety impact in phase 2 datasets.
Gallbladder events: Acute cholelithiasis was reported in one participant at 4.5 mg/week in phase 2, consistent with class-level rapid-weight-loss risk patterns.
Discontinuation profile: Phase 2 discontinuation rates were around 10% across study arms, with roughly 4% discontinuing due to adverse events.
Cardiovascular safety: A thorough QT study reported no clinically relevant QTc prolongation at supratherapeutic dosing; REDEFINE 3 is ongoing for longer-term CV outcomes.
Cagrilintide Clinical Trial Results
Enebo et al. (Lancet, 2021)
Phase 1b • 20 weeks
n=96, BMI 27-39.9
Cagrilintide 2.4 mg + semaglutide 2.4 mg achieved ~17.1% weight loss vs ~9.8% with semaglutide alone.
Lau et al. (Lancet, 2021)
Phase 2 • 26 weeks
n=706, obesity/overweight without T2D
Dose range 0.3-4.5 mg showed ~6.0% to 10.8% weight loss vs ~3.0% placebo; highest dose produced largest reduction.
Frias et al. (Lancet, 2023)
Phase 2 • 32 weeks
n=92, T2D + obesity
CagriSema: -15.6% weight loss; cagrilintide alone: -8.1%; semaglutide alone: -5.1%.
REDEFINE 1 (Garvey et al., NEJM, 2025)
Phase 3a • 68 weeks
n=3,417, obesity/overweight without T2D
CagriSema: -20.4%; cagrilintide mono: -11.8%; semaglutide mono: -14.9%; placebo: -3.0%.
REDEFINE 2 (Davies et al., NEJM, 2025)
Phase 3a • 68 weeks
n=1,206, T2D + BMI >=27
CagriSema: -13.7% body weight and -1.91 pp HbA1c reduction vs placebo -3.4% and -0.16 pp.
REDEFINE 4 (Novo Nordisk, Feb 2026)
Phase 3 • 84 weeks
n=809, obesity; open-label vs tirzepatide
CagriSema: -23.0% vs tirzepatide 15 mg: -25.5%; noninferiority endpoint not met.
REIMAGINE 2 (Novo Nordisk, Feb 2026)
Phase 3 • 68 weeks
n=2,728, T2D on metformin
CagriSema 2.4/2.4 mg: -14.2% body weight and -1.91 pp HbA1c; superior to semaglutide alone.
Cagrilintide's development moved quickly from phase 1b/2 efficacy signals in 2021-2023 into large REDEFINE and REIMAGINE phase 3 programs in 2025-2026. CagriSema consistently outperformed either monotherapy in weight outcomes, including 20.4% in REDEFINE 1 and 13.7% in REDEFINE 2 (T2D). Novo Nordisk filed the CagriSema NDA in December 2025 with a late-2026 decision window, while REDEFINE 3 (CV outcomes), REDEFINE 11 (maintenance), and RENEW monotherapy studies continue.
Storage & Handling
Lyophilized (powder)
-20C (-4F)
Up to 24 months
Lyophilized (short-term)
2-8C (35.6-46.4F)
Acceptable for shipping/short storage
Reconstituted
2-8C (35.6-46.4F)
28-30 days
Cagrilintide has fibrillation sensitivity typical of amylin-based peptides. Avoid vigorous shaking, minimize moisture exposure before reconstitution, protect from light, and avoid repeated freeze-thaw cycles. Discard if solution is cloudy, discolored, or contains visible particulate matter.
Cagrilintide vs. Semaglutide vs. Tirzepatide
Receptor Targets
Cagrilintide: AMY1R/AMY2R/AMY3R + CTR
Semaglutide (Wegovy): GLP-1R
Tirzepatide (Zepbound): GLP-1R + GIPR
Half-Life
Cagrilintide: 159-195 hours (~7-8 days)
Semaglutide (Wegovy): 145-165 hours (~7 days)
Tirzepatide (Zepbound): ~5 days (~120 hours)
Dosing Frequency
Cagrilintide: Once weekly
Semaglutide (Wegovy): Once weekly
Tirzepatide (Zepbound): Once weekly
Max Studied Dose
Cagrilintide: 4.5 mg/week (monotherapy)
Semaglutide (Wegovy): 2.4 mg/week
Tirzepatide (Zepbound): 15 mg/week
Peak Monotherapy Weight Loss
Cagrilintide: 11.8% at 68 weeks (2.4 mg)
Semaglutide (Wegovy): 15-17% at 68 weeks
Tirzepatide (Zepbound): 22.5% at 72 weeks
Peak Combination Weight Loss
Cagrilintide: 20.4% at 68 weeks (CagriSema)
Semaglutide (Wegovy): N/A
Tirzepatide (Zepbound): N/A
FDA Status
Cagrilintide: Investigational; NDA filed Dec 2025 (CagriSema)
Semaglutide (Wegovy): FDA-approved (June 2021)
Tirzepatide (Zepbound): FDA-approved (Nov 2023)
HbA1c Reduction
Cagrilintide: -0.9 pp mono; -1.91 pp in CagriSema
Semaglutide (Wegovy): ~ -1.5 to -1.8 pp
Tirzepatide (Zepbound): ~ -2.0 to -2.4 pp
Unique Advantage
Cagrilintide: Novel amylin pathway; additive with GLP-1
Semaglutide (Wegovy): Established CV outcomes data
Tirzepatide (Zepbound): Highest single-agent obesity efficacy
These compounds target different receptor systems and are not interchangeable.
Cagrilintide's primary value is additive use with GLP-1 therapy (CagriSema), where combined outcomes exceed either monotherapy.
In REDEFINE 4, CagriSema did not meet noninferiority versus tirzepatide 15 mg at 84 weeks; higher-dose combinations are being pursued.
See the semaglutide protocol page and tirzepatide protocol page for compound-specific guides.
Frequently Asked Questions - Cagrilintide
Q1: What is the starting dose of cagrilintide?
Start dose depends on protocol format. CagriSema-style escalation commonly starts at 0.25 mg weekly and steps up every 4 weeks (0.5, 1.0, 1.7, then 2.4 mg). Monotherapy protocols are often started at 0.3-0.6 mg and escalated toward 4.5 mg as tolerated.
Q2: What is cagrilintide's half-life?
Reported plasma half-life is about 159-195 hours (roughly 6.6-8.1 days), supporting once-weekly dosing. Around the 2.4 mg dose, values near 184 hours have been reported in program summaries.
Q3: What weight loss results can be expected from cagrilintide?
In REDEFINE 1, cagrilintide monotherapy at 2.4 mg showed 11.8% mean weight loss at 68 weeks. In phase 2, 4.5 mg reached 10.8% at 26 weeks. Combination outcomes were higher with CagriSema, including 20.4% at 68 weeks and 23.0% in the REDEFINE 4 readout.
Q4: How do you reconstitute cagrilintide?
Reconstitute lyophilized cagrilintide with bacteriostatic water by injecting slowly down the vial wall, then gently swirl until clear. Do not shake. Typical examples are 5 mg + 2.0 mL (2.5 mg/mL) and 10 mg + 3.0 mL (3.33 mg/mL). Calculator: https://www.peppal.app/calculator
Q5: Is cagrilintide FDA-approved?
No. Cagrilintide is not FDA-approved as a standalone product as of March 2026. Novo Nordisk filed an NDA for CagriSema in December 2025, with a late-2026 decision window referenced in current program updates.
Q6: What are the most common side effects?
Most common effects are gastrointestinal and dose-dependent, especially nausea, constipation, diarrhea, and vomiting during escalation. Injection-site reactions are also reported. Clinical datasets describe mostly mild-to-moderate events with improved tolerance after dose stabilization.
Q7: How does cagrilintide compare to semaglutide and tirzepatide?
Cagrilintide targets amylin and calcitonin receptor pathways, while semaglutide targets GLP-1 and tirzepatide targets GLP-1/GIP. Cagrilintide monotherapy generally trails semaglutide and tirzepatide in weight-loss magnitude, but combined amylin + GLP-1 therapy (CagriSema) has shown additive outcomes.
Q8: What vial sizes are available for cagrilintide?
Most research suppliers list 5 mg and 10 mg lyophilized vials. At 2.4 mg/week, a 5 mg vial is roughly a 2-week supply and a 10 mg vial is roughly a 4-week supply before accounting for dead-space loss.
Q9: How much bacteriostatic water should be added to cagrilintide?
Volume depends on target concentration. Common mixes are 5 mg + 2.0 mL (2.5 mg/mL), 10 mg + 3.0 mL (3.33 mg/mL), or 10 mg + 2.0 mL (5.0 mg/mL). Use the PepPal calculator for exact unit conversion at your chosen concentration: https://www.peppal.app/calculator
Q10: What is the maximum dose of cagrilintide studied?
The highest monotherapy dose studied in clinical trials is 4.5 mg/week. In contrast, the phase 3 CagriSema program uses 2.4 mg/week cagrilintide with semaglutide, and higher-dose combination variants are being evaluated.
Q11: How should reconstituted cagrilintide be stored?
Store reconstituted cagrilintide at 2-8C, protected from light, and use within about 28-30 days. Do not freeze reconstituted solution. Discard if cloudy, discolored, or if visible particles appear.
Q12: What is the current clinical trial program for cagrilintide?
Current programs include REDEFINE (obesity/overweight), REIMAGINE (type 2 diabetes), and planned/ongoing RENEW monotherapy development. Key named studies include REDEFINE 1/2/3/4/11 and REIMAGINE 2, with additional long-term outcomes work in progress.
Sources & Research
- Kruse T, Dahl K, Schaffer L, et al. "Development of Cagrilintide, a Long-Acting Amylin Analogue." Journal of Medicinal Chemistry, 2021 Link.
- Enebo LB, Berthelsen KK, Kankam M, et al. "Safety, tolerability, pharmacokinetics, and pharmacodynamics of cagrilintide with semaglutide for weight management." The Lancet, 2021 Link.
- Lau DCW, Erichsen L, Francisco AM, et al. "Once-weekly cagrilintide for weight management in overweight and obesity." The Lancet, 2021 Link.
- Frias JP, Deenadayalan S, Erichsen L, et al. "Efficacy and safety of co-administered cagrilintide with semaglutide in type 2 diabetes." The Lancet, 2023 Link.
- Garvey WT, et al. "Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity." New England Journal of Medicine, 2025 Link.
- Davies MJ, Bajaj HS, Broholm C, et al. "Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes." New England Journal of Medicine, 2025 Link.
- Gabe MBN, et al. "Cagrilintide is not associated with clinically relevant QTc prolongation." Diabetes, Obesity and Metabolism, 2024 Link.
- Dutta D, et al. "Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (CagriSema)." Indian Journal of Endocrinology and Metabolism, 2024.
- Fletcher MM, et al. "Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors." Nature Communications, 2025 Link.
- ClinicalTrials.gov — (NCT05567796), (NCT05394519), (NCT05669755), (NCT06131437), (NCT07011667), (NCT06065540), (NCT05804162).
- Novo Nordisk files for FDA approval of CagriSema (Dec 18, 2025). Link.
- Novo Nordisk REDEFINE 4 update: 23% weight loss at 84 weeks (Feb 23, 2026). Link.
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Disclaimer
The information on this page is for educational and research reference purposes only. Cagrilintide is investigational and is not FDA-approved as a standalone product. No compounds discussed on this site are intended for human consumption. This content is not medical advice and does not replace qualified clinical care.
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