Human studiesLong-acting amylin analog

Cagrilintide

NN9838, the amylin half of CagriSema

Common dose: 0.25 → 2.4 mg weekly
Cycle: Continuous
Vial sizes: 5, 10 mg
Typical draw: 5 units5 mg with 1 mL, 0.25 mg

A once-weekly amylin analog that increases fullness and reduces food intake. It is being developed mainly in combination with semaglutide.

Evidence. Investigational (Novo Nordisk). Studied alone in Phase 2, and with semaglutide (as CagriSema) in Phase 3, where cagrilintide alone was also a comparison arm. Novo Nordisk filed CagriSema with FDA in December 2025; not approved as of October 2026.

Status

Approval: Not approved in the US or EU. Novo Nordisk filed CagriSema (cagrilintide plus semaglutide) with FDA in December 2025; not approved as of early October 2026.
Sport (WADA 2026): Likely banned in sportNot named on WADA’s 2026 list, but its S0 rule bans drugs with no current human approval anywhere, at all times.

Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026.

Protocol

Trial

Phase 2, Lancet 2021

Alone: 0.3–4.5 mg once weekly for 26 weeks. Weight loss rose with dose, reaching 10.8% at 4.5 mg.

Trial

REDEFINE trials

CagriSema: 2.4 mg cagrilintide with 2.4 mg semaglutide weekly, reached in 4-week steps over 16 weeks.

Frequency: Once weekly
Route: Subcutaneous injection
Cycle: Continuous in trials (26–68 weeks).
Continuous, shown over 26 weeks

Common protocols

The ways Cagrilintide is most often run, each tagged with where it comes from.

CagriSema

Trial

Dose: 2.4 mg with 2.4 mg semaglutide
How often: Once weekly
How long: 68 weeks

Both drugs stepped up together. Mean loss 20.4% vs 3.0% on placebo (REDEFINE 1). Some stayed on a lower dose.

Alone (Phase 2)

Trial

Dose: 0.3–4.5 mg
How often: Once weekly
How long: 26 weeks

Loss rose with dose. 4.5 mg gave 10.8%, vs 9.0% on liraglutide 3.0 mg and 3.0% on placebo.

Draw 6–90 units5 mg + 1 mL

CagriSema step-up (same dose of each drug)

Period	Dose	Draw at 5 mg/mL
Weeks 1–4	0.25 mg	5 units (0.05 mL)
Weeks 5–8	0.5 mg	10 units (0.10 mL)
Weeks 9–12	1 mg	20 units (0.20 mL)
Weeks 13–16	1.7 mg	34 units (0.34 mL)
Week 17 on	2.4 mg	48 units (0.48 mL)

Units assume a 5 mg vial mixed with 1 mL. Use the calculator for other vial sizes.

Levels over time

How much of the drug is in the body week by week, worked out from its trial half-life of about 7 days. It shows the build-up to a steady level and the fall after the last dose.

On the same dose every week, levels reach about 90% of steady state after 4 doses. After the last dose, about 50% is left a week later, and levels fall below 5% after about 5 weeks.

Show the numbers

Week	Dose that week	Average level that week
1	0.25 mg	5%
2	0.25 mg	8%
3	0.25 mg	9%
4	0.25 mg	10%
5	0.5 mg	15%
6	0.5 mg	18%
7	0.5 mg	19%
8	0.5 mg	20%
9	1 mg	31%
10	1 mg	36%
11	1 mg	39%
12	1 mg	40%
13	1.7 mg	56%
14	1.7 mg	63%
15	1.7 mg	67%
16	1.7 mg	69%
17	2.4 mg	84%
18	2.4 mg	92%
19	2.4 mg	96%
20	2.4 mg	98%
21	2.4 mg	99%
22	2.4 mg	100%
23	2.4 mg	100%
24	2.4 mg	100%
25	–	50%
26	–	25%
27	–	12%
28	–	6%
29	–	3%

A simple model: each point is the average level over one week, so it leaves out the rise and dip within the week, and it uses one average half-life, so real levels vary from person to person. 100% is the steady weekly average on the final dose shown. Half-life from published trials.

Taking it

Where it goes

Injected under the skin once a week in trials. The belly, thigh or upper arm are the usual sites, rotated each week.

If you miss a dose

No label or published trial rule yet. Common practice is to take the next dose on schedule without doubling up. For comparison, the Wegovy label restarts at a lower dose after 2+ missed doses.

What to expect

Weeks 1–16
CagriSema steps both drugs up together every 4 weeks. Investigators could keep people on a lower dose if needed.
Trial
Week 26
Alone (Phase 2): 10.8% mean loss on 4.5 mg vs 9.0% on liraglutide 3.0 mg and 3.0% on placebo.
Trial
Week 68
CagriSema: 20.4% mean loss vs 3.0% on placebo. About 1 in 3 lost 25% or more. 6% stopped for side effects vs 3.7%.
Trial

Side effects and what to do

Nausea (CagriSema: 55% vs 12.6% placebo)

Mostly mild to moderate and passing. Smaller meals help. Ongoing vomiting needs medical advice.

Constipation (30.7% vs 11.6%) and vomiting (26.1% vs 4.1%) on CagriSema

Fluids and fiber help constipation. Don’t push through repeated vomiting.

GI side effects alone (Phase 2: 41–63% vs 32% placebo)

Rates were similar to liraglutide 3.0 mg.

Stop and get medical help

Severe belly pain that won’t go away, repeated vomiting or signs of dehydration (dizziness, very little urine), or face or throat swelling or trouble breathing. Get medical help.

Tracking and pairing

Worth tracking

Hydration if vomiting or diarrhea is heavy

Often paired with

Semaglutide (CagriSema)
The Phase 3 combination: 20.4% mean loss at 68 weeks vs 3.0% on placebo, with more GI side effects.

Human studies

5 key published human studies, with how many people took part. Animal studies aren’t listed here.

20253,417 people

Weight fell 20.4% with CagriSema vs 3.0% on placebo; 302 people got cagrilintide alone.

Design
Randomized controlled trial (phase 3a)
Dose
CagriSema 2.4 mg + 2.4 mg weekly; arms with cagrilintide 2.4 mg alone, semaglutide alone, placebo
Length
68 weeks

Garvey et al., N Engl J Med 2025 (REDEFINE 1), PMID 40544433
20262,713 people

In type 2 diabetes, HbA1c fell 1.91 points with CagriSema 2.4 + 2.4 mg vs 1.75 with semaglutide 2.4 mg alone.

Design
Randomized controlled trial (phase 3)
Dose
CagriSema 2.4 + 2.4 mg or 1.0 + 1.0 mg, semaglutide alone, cagrilintide 2.4 mg alone, or placebo
Length
68 weeks

Buse et al., Lancet Diabetes Endocrinol 2026 (REIMAGINE 2), PMID 42251859
20251,206 people

Weight fell 13.7% with CagriSema vs 3.4% on placebo in adults with obesity and type 2 diabetes.

Design
Randomized controlled trial (phase 3a)
Dose
CagriSema 2.4 mg + 2.4 mg weekly
Length
68 weeks

Davies et al., N Engl J Med 2025 (REDEFINE 2), PMID 40544432
2021706 people

Weight fell 6.0% to 10.8% with cagrilintide vs 3.0% on placebo and 9.0% on liraglutide 3.0 mg daily.

Design
Randomized controlled trial (phase 2)
Dose
Cagrilintide alone 0.3 to 4.5 mg weekly
Length
26 weeks

Lau et al., Lancet 2021, PMID 34798060
202196 people

Weight fell 15.4% to 17.1% with cagrilintide 1.2 to 4.5 mg plus semaglutide vs 8.0% to 9.8% with semaglutide plus placebo.

Design
Randomized controlled trial (phase 1b)
Dose
Cagrilintide 0.16 to 4.5 mg weekly with semaglutide 2.4 mg
Length
20 weeks

Enebo et al., Lancet 2021, PMID 33894838

Mixing your vial

Vial	Water	Common dose	Draw	Strength	Action
5 mg	1 mL	0.25 mg	5 units (0.05 mL)	5 mg/mL
10 mg	2 mL	0.25 mg	5 units (0.05 mL)	5 mg/mL

Dose chart

Syringe units for common doses at different water volumes. Select a cell to open it in the calculator.

Dose	Water added
Dose	1 mL	2 mL	3 mL
0.25 mg
0.5 mg
1 mg
1.7 mg
2.4 mg
4.5 mg

U-100 insulin syringe: 100 units is 1 mL. Draws over 100 units show in mL. Faded values are under 2 units, which is hard to measure. Check that your vial holds the larger volumes.

Datasheet

Half-life: about 7 to 8 days (159 to 195 hours) TrialSubcutaneous weekly doses of 0.16 to 4.5 mg given with semaglutide 2.4 mg, in adults with overweight (phase 1b).
Type: Peptide, 37 amino acids
Molecular weight: 4,409.1 g/mol
Formula: C₁₉₄H₃₁₂N₅₄O₅₉S₂
Sequence: KCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTPFatty-acid chain on the N-terminus; C-terminal amide
Storage before use: Freezer for long-term storage; keep the vial sealed, dry and out of light.
After mixing or opening: Fridge (2–8 °C) after mixing; use within about 4 weeks.

Half-life: Enebo et al., Lancet 2021, PMID 33894838
Molecule: ChEMBL CHEMBL4802169 (sequence); PubChem CID 171397054 (formula)
Storage: Community Common community practice; no label or manufacturer storage data exist for this compound.

Cautions

Investigational.
Nausea, constipation and vomiting were common with CagriSema.
Combining it with a GLP-1 adds GI side effects; the trials stepped both drugs up together.

Questions

What is cagrilintide?

A once-weekly amylin analog that increases fullness and reduces food intake. It is being developed mainly in combination with semaglutide.

Is cagrilintide FDA-approved?

Not approved in the US or EU. Novo Nordisk filed CagriSema (cagrilintide plus semaglutide) with FDA in December 2025; not approved as of early October 2026.

What is the usual cagrilintide dose?

From human studies (Phase 2, Lancet 2021): Alone: 0.3–4.5 mg once weekly for 26 weeks. Weight loss rose with dose, reaching 10.8% at 4.5 mg. CagriSema: 2.4 mg cagrilintide with 2.4 mg semaglutide weekly, reached in 4-week steps over 16 weeks (REDEFINE trials). These are the amounts sources reference, not recommendations.

How much water do I mix cagrilintide with?

There’s no single right amount, because the water only sets the strength. With 1 mL of bacteriostatic water in a 5 mg vial, the strength is 5 mg/mL, so 0.25 mg is 5 units on a U-100 insulin syringe. More water makes small doses easier to measure. The dose chart above shows other volumes.

What is the half-life of cagrilintide?

About 7 to 8 days (159 to 195 hours), measured in human studies. Subcutaneous weekly doses of 0.16 to 4.5 mg given with semaglutide 2.4 mg, in adults with overweight (phase 1b).

How should cagrilintide be stored?

Before mixing: Freezer for long-term storage; keep the vial sealed, dry and out of light. Fridge (2–8 °C) after mixing; use within about 4 weeks. This is common practice; no product label covers it.

Is cagrilintide banned in sport?

Probably. Not named on WADA’s 2026 list, but its S0 rule bans drugs with no current human approval anywhere, at all times.

Has cagrilintide been studied in people?

Yes. The human studies section lists 5 published studies. The largest, from 2025, included 3,417 people. Weight fell 20.4% with CagriSema vs 3.0% on placebo; 302 people got cagrilintide alone.

Sources

Lau et al., Phase 2 dose-finding trial (Lancet 2021)
Garvey et al., REDEFINE 1 (NEJM 2025) doi:10.1056/NEJMoa2502081

For the protocol details

Novo Nordisk: CagriSema REDEFINE 1 results published in NEJM (June 2025)
2 Minute Medicine: cagrilintide Phase 2 trial summary (Lancet 2021)
Wegovy prescribing information, rev. 06/2026 (missed-dose comparison)

By Vial Guide editorsLast reviewed October 5, 2026

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