Peptide Name
Cagrilintide
Updated April 2026
Cagrilintide Dosing Protocol
Written by Garret Grant
Founder & Lead Researcher · B.S. Civil Engineering, UCLA
Last updated: April 2026
Human-researched and AI-assisted with full editorial review. I verify sources, protocol interpretation, and final judgments personally. See methodology.
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Complete Dosing & Safety Guide for Cagrilintide, a Once-Weekly Amylin Analogue Frequently Discussed Alongside Semaglutide in CagriSema research, covering titration schedules, reconstitution math, half-life, side effects, clinical trial outcomes, and current regulatory context.
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 Dosing Card
Research Status
Investigational phase 3 program with NDA filed for CagriSema in December 2025; standalone cagrilintide remains under evaluation.
Use Case
Research users commonly explore cagrilintide for appetite control and weight-management signaling in once-weekly protocols.
Aliases
AM833, NN9838
Category / Class
Long-Acting Amylin Analogue / Dual Amylin & Calcitonin Receptor Agonist (DACRA) - a once-weekly peptide designed to mimic satiety signaling.
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)
Titration Schedule
Monotherapy: 0.6 mg -> 1.2 mg -> 2.4 mg -> 4.5 mg weekly; CagriSema: 0.25 mg -> 0.5 mg -> 1.0 mg -> 1.7 mg -> 2.4 mg weekly
Common Vial Sizes
5 mg, 10 mg
Route of Administration
Subcutaneous injection
Regulatory Status
Investigational - Phase 3. Cagrilintide is not FDA-approved as a standalone product. Novo Nordisk filed an NDA for the CagriSema combination in December 2025, with an FDA decision anticipated in 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 once-weekly investigational peptide being studied for appetite control and weight management. Developed by Novo Nordisk, it is also known as AM833 and NN9838. Unlike semaglutide and tirzepatide, which work through GLP-1-based pathways, cagrilintide is an amylin-based compound designed to mimic satiety signaling.
It is classified as a long-acting amylin analogue and a dual amylin and calcitonin receptor agonist (DACRA). In practical terms, that means it is designed to help people feel full sooner, stay full longer, and support once-weekly dosing rather than daily administration. Its structural modifications improve stability, reduce fibrillation risk, and allow reversible albumin binding, which helps explain the ~7-8 day half-life.
Cagrilintide is being studied both as monotherapy (RENEW program) and in fixed-dose combination with semaglutide 2.4 mg as CagriSema across the 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 works through two connected satiety pathways. In practical terms, it is designed to help people feel full sooner, stay full longer, and empty the stomach more slowly - which is why it is often discussed as a weight-management peptide rather than just a receptor diagram.
Amylin Receptors (AMY1R, AMY2R, AMY3R) - Satiety Signaling & Appetite Suppression
Amylin receptors are built from the calcitonin receptor plus helper proteins called RAMP1, RAMP2, and RAMP3. These receptors are concentrated in brain regions involved in fullness signaling, including the area postrema and hypothalamus. When cagrilintide activates them, appetite signaling shifts toward eating less and feeling satisfied earlier. Preclinical findings suggest AMY1R and AMY3R may be especially relevant for weight-response effects while helping preserve lean mass during weight reduction.
Calcitonin Receptor (CTR) - Gastric Emptying & Glucagon Suppression
The calcitonin receptor adds a second effect layer. It slows gastric emptying, meaning food leaves the stomach more slowly, and it extends post-meal fullness. It is also linked to lower glucagon release after meals and improved glycemic handling. Possible energy-expenditure effects are still being studied and remain less defined in humans.
Combined Pathway Summary
Together, these pathways create a two-part profile: stronger satiety signaling in the brain and slower gastric emptying in the gut. That makes cagrilintide complementary to GLP-1 agonism rather than a duplicate of it, which helps explain the additive outcomes seen 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: Gastrointestinal side effects tend to increase as dose rises, so the step-up schedule is used to improve tolerability rather than delay progress.
Dose flexibility: Phase 2 studied monotherapy doses from 0.3-4.5 mg/week. By contrast, the phase 3 CagriSema programs centered on 2.4 mg/week of cagrilintide alongside semaglutide.
Missed dose guidance: Because cagrilintide has a ~7-8 day half-life, a missed weekly dose can be taken if the next scheduled dose is more than 3 days away. If the next dose is closer than 3 days, skip the missed dose and return to the normal schedule. Do not double dose.
Phase 3 context: REDEFINE and REIMAGINE used a 16-week escalation schedule to reach 2.4 mg/week in combination regimens, while RENEW continues to evaluate monotherapy.
Cagrilintide Reconstitution Guide
Vial Size: 5 mg
BAC Water Added: 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 Added: 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 Added: 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 Added: 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 side effects are the most common adverse events reported with cagrilintide, and they generally become more likely as dose increases 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% with placebo, with nausea as the most frequent event. REDEFINE 1 also reported higher GI event rates in CagriSema versus placebo.
Injection-site reactions: Injection-site reactions were more frequent in cagrilintide-containing arms than with semaglutide alone, but they were typically mild and self-limited.
Antibody formation: A minority of participants developed anti-cagrilintide antibodies during extended treatment, but phase 2 datasets did not show a clear effect on efficacy or safety.
Gallbladder events: One participant at 4.5 mg/week developed acute cholelithiasis (gallstones) in phase 2, which is consistent with class-level rapid-weight-loss risk patterns.
Discontinuation profile: Phase 2 discontinuation rates were around 10% across study arms, with roughly 4% stopping treatment because of adverse events.
Cardiovascular safety: A thorough QT study found no clinically relevant QTc prolongation, meaning no meaningful signal for delayed heart repolarization, even at supratherapeutic dosing. REDEFINE 3 is ongoing for longer-term cardiovascular outcomes.
For a cross-class safety comparison, see the PepPal Peptide Side Effects Guide.
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.
The trial progression above shows a clear pattern: early studies established dose response and tolerability, then larger phase 3 programs tested whether those effects held up in much bigger obesity and type 2 diabetes populations. Across that development path, cagrilintide alone produced meaningful weight-loss results, but the strongest outcomes so far have come from pairing it with semaglutide as CagriSema.
That includes 20.4% mean weight loss in REDEFINE 1 and 13.7% in REDEFINE 2 for participants with type 2 diabetes. 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 the same kind of clumping sensitivity seen with many amylin-based peptides, which is why gentle handling matters. Avoid vigorous shaking, minimize moisture exposure before reconstitution, protect the vial from light, and avoid repeated freeze-thaw cycles. Discard the solution if it becomes cloudy, discolored, or develops visible particles.
Cagrilintide vs. Semaglutide vs. Tirzepatide
Use this table to compare receptor targets, dosing range, weight-loss outcomes, and regulatory status across the three compounds at a glance.
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 act on different receptor systems, so they should be viewed as distinct tools rather than interchangeable versions of the same drug class. If you want to see also tesofensine for a non-peptide, oral fat-loss option, compare its central monoamine mechanism against cagrilintide's amylin pathway.
Cagrilintide's main differentiator is its amylin pathway and its additive use with GLP-1 therapy as CagriSema, where combined outcomes have exceeded either monotherapy alone.
In REDEFINE 4, CagriSema did not meet the noninferiority target versus tirzepatide 15 mg at 84 weeks, meaning it did not statistically prove it was at least as effective in that comparison. Higher-dose combinations are still being pursued.
See the semaglutide protocol page and tirzepatide protocol page for compound-specific guides.
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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 April 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.
Q13: Where can I calculate reconstitution and syringe units?
Use the PepPal calculator for exact dose-to-unit conversions.
Q14: Where can I compare peptide suppliers?
Browse the PepPal supplier directory for current supplier listings.
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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