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Metabolic · Dosing reference

Cagrilintide dosage

Doses given in registered human trials, how long they ran, and the arithmetic for working with vials.

InvestigationalAHuman trial evidenceTrial doses
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Regulatory status
Investigational
Human amounts
Trial doses: 0.3 to 4.5 mg once weekly (phase 2 monotherapy); 2.4 mg once weekly in phase 3 (alone or with semaglutide 2.4 mg)
Route studied
Subcutaneous injection
Frequency
Once weekly in all trials reviewed
Half-life
159 to 195 hours (phase 1b, co-administered with semaglutide 2.4 mg) 2
Evidence grade
Grade A · Human trial evidence
Vial sizes on the market
5 mg · 10 mg
Other forms seen
—

What Cagrilintide is

Cagrilintide is an investigational long-acting, lipidated analogue of the pancreatic hormone amylin that acts at amylin and calcitonin receptors and is given by once-weekly subcutaneous injection in clinical trials. It has been studied alone in a phase 2 weight-management trial and, most extensively, in combination with semaglutide (CagriSema) in phase 3 trials, with gastrointestinal events the most commonly reported adverse events. It is not approved by the FDA, and this entry summarizes published and registered trials for research reference only.

Natural amylin is a pancreatic hormone co-secreted with insulin that induces satiety; cagrilintide is a stable, lipidated, long-acting amylin analogue 1,7. Receptor pharmacology Cryo-electron microscopy structures show cagrilintide bound to Gs-coupled amylin receptors (AMY1R, AMY2R, AMY3R) and the calcitonin receptor, with an amylin-like binding mode but distinct conformational dynamics compared with other… How it works →

Key evidence

  • Lau et al., Lancet (phase 2, monotherapy) · 2021 · Humans (adults with overweight or obesity without diabetes)
    Mean weight reduction was 6.0% to 10.8% across cagrilintide doses versus 3.0% with placebo; the highest dose exceeded liraglutide 3.0 mg (10.8% vs 9.0%); gastrointestinal adverse events occurred in 41% to 63% versus 32% with placebo 1. 1
  • Enebo et al., Lancet (phase 1b, with semaglutide) · 2021 · Humans (otherwise healthy adults with BMI 27.0 to 39.9)
    Most adverse events were mild to moderate and 37% were gastrointestinal; cagrilintide half-life was 159 to 195 hours, and weight reduction at week 20 was greater with cagrilintide 1.2 mg and 2.4 mg plus semaglutide than with placebo plus semaglutide 2. 2
  • Frias et al., Lancet (phase 2, type 2 diabetes) · 2023 · Humans (adults with type 2 diabetes and BMI 27 or higher on metformin)
    HbA1c change was -2.2 (combination), -1.8 (semaglutide) and -0.9 (cagrilintide alone) percentage points; body-weight change was -15.6%, -5.1% and -8.1%; adverse events were reported by 68%, 71% and 80%, with no level 2 or 3 hypoglycaemia 3. 3
All studies on the research page

Schedules by time period

study arms from registered trials, laid out week by week. Each bar is what the label states or what investigators gave participants; none is a recommendation.

Registered trial

Phase 2 monotherapy dose-finding trial (NCT03856047): study arms 16,1

Adults without diabetes with BMI 30 or higher, or 27 or higher with hypertension or dyslipidaemia (706 randomized) · 26 weeks

0.3 mg
SC · once weekly
Week-by-week table
PeriodAmount
Weeks 0–260.3 mg (maintenance)

No escalation described for this arm in the registry.

0.6 mg
SC · once weekly
Week-by-week table
PeriodAmount
Weeks 0–260.6 mg (maintenance)

No escalation described for this arm in the registry.

1.2 mg
SC · once weekly
Week-by-week table
PeriodAmount
Weeks 0–20.6 mg
Weeks 2–261.2 mg (maintenance)
2.4 mg
SC · once weekly
Week-by-week table
PeriodAmount
Weeks 0–20.6 mg
Weeks 2–41.2 mg
Weeks 4–262.4 mg (maintenance)
4.5 mg
SC · once weekly
Week-by-week table
PeriodAmount
Weeks 0–20.6 mg
Weeks 2–41.2 mg
Weeks 4–62.4 mg
Weeks 6–264.5 mg (maintenance)

Dose escalated every other week to the target dose (dose-escalation period of up to 6 weeks within the 26-week treatment period). Comparators: liraglutide 3.0 mg once daily (escalated 0.6 mg week 0, 1.2 mg week 1, 1.8 mg week 2, 2.4 mg week 3, 3.0 mg weeks 4-26) and volume-matched placebo.

Doses given in human trials

  • In the phase 2 dose-finding trial (NCT03856047), adults with overweight or obesity self-injected subcutaneous cagrilintide 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly, once-daily liraglutide 3.0 mg, or volume-matched placebo for 26 weeks, including a dose-escalation period of up to 6 weeks, followed by 6 weeks without treatment 1.
  • In the phase 1b trial (NCT03600480), participants received once-weekly subcutaneous cagrilintide 0.16, 0.30, 0.60, 1.2, 2.4 or 4.5 mg or placebo together with once-weekly semaglutide 2.4 mg; doses were co-escalated at 4-week intervals over 16 weeks, then held at target for 4 weeks 2.
  • In the phase 2 type 2 diabetes trial (NCT04982575), participants were randomized 1:1:1 to once-weekly subcutaneous cagrilintide-semaglutide, semaglutide or cagrilintide, all escalated to 2.4 mg, for 32 weeks 3.
  • In REDEFINE 1 (NCT05567796), participants received once-weekly cagrilintide 2.4 mg plus semaglutide 2.4 mg, semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo for 68 weeks; the registry describes a 16-week dose-escalation period followed by maintenance 4,12.
  • In REDEFINE 2 (NCT05394519), adults with type 2 diabetes received once-weekly cagrilintide-semaglutide (2.4 mg each) or placebo for 68 weeks 5.
  • In REIMAGINE 2 (NCT06065540), participants received once-weekly subcutaneous cagrilintide 2.4 mg plus semaglutide 2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg, cagrilintide 1.0 mg plus semaglutide 1.0 mg, semaglutide 1.0 mg, or placebo for 68 weeks 6.

How long did human studies run?

  • Phase 2 monotherapy: 26 weeks of treatment plus 6 weeks of follow-up 1.
  • Phase 2 type 2 diabetes: 32 weeks 3.
  • Phase 3 REDEFINE 1, REDEFINE 2 and REIMAGINE 2: 68 weeks 4,5,6.
Cycle-length evidence for Cagrilintide

Who was excluded from the studies

  • The phase 2 monotherapy trial enrolled adults without diabetes with BMI 30 or higher, or 27 or higher with hypertension or dyslipidaemia 1.
  • REDEFINE 1 enrolled adults without diabetes; REDEFINE 2 enrolled adults with type 2 diabetes and HbA1c 7% to 10% 4,5.
  • No pediatric or pregnancy data were identified in the sources reviewed; there is no label with contraindications 13.

Side effects reported in studies

  • Gastrointestinal adverse events (cagrilintide alone)
    41% to 63% across cagrilintide doses vs 32% placebo · Phase 2 monotherapy trial, 26 weeks 1
  • Nausea (cagrilintide alone)
    20% to 47% across cagrilintide doses vs 18% placebo · Phase 2 monotherapy trial, 26 weeks 1
  • Permanent treatment discontinuation
    73 participants (10%), similar across groups; most commonly due to adverse events (30, 4%) · Phase 2 monotherapy trial 1
  • Any adverse event (cagrilintide alone)
    125 of 152 (82.2%) vs 105 of 149 (70.5%) placebo · REIMAGINE 2, type 2 diabetes, 68 weeks 6
  • Any adverse event (cagrilintide alone)
    24 of 30 (80%) · Phase 2 type 2 diabetes trial, 32 weeks 3
  • Gastrointestinal adverse events (combination)
    79.6% vs 39.9% placebo · REDEFINE 1, adults without diabetes, 68 weeks 4
  • Gastrointestinal adverse events (combination)
    72.5% vs 34.4% placebo · REDEFINE 2, adults with type 2 diabetes, 68 weeks 5
Full adverse-event data

Cagrilintide draw calculator

Pick the vial strength and the water added, enter an amount, and see the concentration, the units to draw and how many draws the vial holds. Arithmetic only.

1 · Vial strength
sizes on the market
2 · Water added
3 · Amount per draw
4 · Syringe
Your mix
10 mg + 2 mL water = 5 mg/mL
10 units holds 0.5 mg (500 mcg)
Draw toEnter an amount in step 3
0102030405060708090100
U-100 syringe · 100 units = 1 mL

Computed from your inputs. Not a dose or a recommendation.

Compare water volumes for this vialShow

More water = lower concentration = a larger, easier-to-measure draw. Tap a row to use it.

Watermg/mLDraw
0.5 mL20—
1 mL10—
1.5 mL6.667—
2 mL5—
2.5 mL4—
3 mL3.333—
5 mL2—

Supplies and handling

  • Lyophilized vial
    Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
  • Sterile diluent
    The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
  • Graduated syringes
    Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
  • Alcohol prep pads
    For wiping vial stoppers before each puncture.
  • Nitrile gloves
    Clean gloves for aseptic handling.
  • Sharps container
    Puncture-resistant container for used needles.
Step-by-step reconstitution guideStorage and transport accessories

Storage

No approved-product storage instructions exist because cagrilintide has no FDA label. Handling of research material should follow the supplier's documentation and certificate of analysis, including temperature, light protection and freeze-thaw limits.

  • Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
  • Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
  • Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent
The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed
Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles
Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution
This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed
Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status
Not approved by the FDA; an openFDA Drugs@FDA query for cagrilintide returned no application record 13. Cagrilintide is described in trial reports as a long-acting amylin analogue under investigation for weight management 1, and the REDEFINE 1 phase 3 trial (NCT05567796) is listed on ClinicalTrials.gov as active, not recruiting, with an extension phase 12.
United States (FDA)
Not approved; an openFDA Drugs@FDA query for cagrilintide returned no application record 13. Phase 3 trials are registered on ClinicalTrials.gov 12.
Sport (WADA)
Cagrilintide is not named on the WADA 2026 Prohibited List 15. Class S0 prohibits at all times any pharmacological substance not addressed elsewhere on the List and with no current approval by any governmental regulatory health authority for human therapeutic use, such as drugs under clinical development 15.

Status varies by country and changes over time. How we describe regulatory status.

Cagrilintide compared with related compounds

CompoundStatusEvidenceHuman amountsHalf-life
CagrilintideInvestigationalATrial doses159 to 195 hours (phase 1b, co-administe
SemaglutideFDA-approvedAFDA labelApproximately 1 week; present in the cir
EloralintideInvestigationalATrial dosesTerminal geometric mean half-life of 310
TesofensineInvestigationalBTrial dosesAbout 234 hours (M1 metabolite about 374
MazdutideApproved outside the USATrial doses150.9 to 403.5 hours (phase 1b in overwe
SLU-PP-332Not approved — research use onlyCNone establishedUnknown in humans

Combinations that include Cagrilintide

Frequently asked questions

What doses of Cagrilintide have been studied in humans?
Cagrilintide is investigational. This page lists the amounts given in each cited trial as facts about those studies.
Is there an established Cagrilintide cycle length?
No cycle length or break has been established. Human studies administered Cagrilintide for the periods listed on this page; those are study durations, not a recommended course.
How much bacteriostatic water should be added to a Cagrilintide vial?
There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.
How many units is a given amount on an insulin syringe?
On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.
What is the half-life of Cagrilintide?
159 to 195 hours (phase 1b, co-administered with semaglutide 2.4 mg) 2
Is Cagrilintide FDA-approved?
Investigational. Not approved by the FDA; an openFDA Drugs@FDA query for cagrilintide returned no application record 13. Cagrilintide is described in trial reports as a long-acting amylin analogue under investigation for weight management 1, and the REDEFINE 1 phase 3 trial (NCT05567796) is listed on ClinicalTrials.gov as active, not recruiting, with an extension phase 12.

References

  1. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial Lancet. 2021
  2. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial Lancet. 2021
  3. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial Lancet. 2023
  4. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1) N Engl J Med. 2025
  5. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2) N Engl J Med. 2025
  6. Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study Lancet Diabetes Endocrinol. 2026
  7. Development of Cagrilintide, a Long-Acting Amylin Analogue J Med Chem. 2021
  8. Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors Nat Commun. 2025
  9. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3 EBioMedicine. 2025
  10. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1 Hypertension. 2026
  11. Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti-Obesity Medications: A Systematic Review, Meta-Analysis and Meta-Regression Diabetes Obes Metab. 2026
  12. A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1, NCT05567796) ClinicalTrials.gov. 2026
  13. Drugs@FDA application data queried through openFDA for cagrilintide (no matching application record returned on 23 October 2026) openFDA / Drugs@FDA. 2026
  14. PubChem compound record for cagrilintide (CID 171397054; CAS 1415456-99-3) PubChem. 2026
  15. International Standard: Prohibited List 2026 World Anti-Doping Agency. 2026
  16. Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity (registry results: participant flow group descriptions) ClinicalTrials.gov. 2023

Last reviewed October 23, 2026 by the Amiravo editorial team. Editorial policy · Report an error