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Metabolic & weight

Cagrilintide (and CagriSema)

Also called NN9838, CagriSema (cagrilintide + semaglutide), long-acting amylin analog

Cagrilintide is an experimental weekly shot that mimics amylin, a fullness hormone made by the pancreas. Novo Nordisk combines it with semaglutide in a product called CagriSema. CagriSema produced about 20–23% weight loss in trials and is under FDA review.

Late-stage trialsTested in large human trials (phase 2b/3) but not yet approved in the US.

All printable flashcards

Illustrative chain. The exact sequence has not been published in a source we could verify.

Overview

Cagrilintide is an experimental weekly shot that mimics amylin, a fullness hormone made by the pancreas. Novo Nordisk combines it with semaglutide in a product called CagriSema. CagriSema produced about 20–23% weight loss in trials and is under FDA review.

How it works

Established in trials: cagrilintide activates amylin and calcitonin receptors, which increases feelings of fullness and slows stomach emptying. Combining it with semaglutide (a GLP-1 agonist) adds two different appetite signals, which is proposed to explain the greater weight loss than either drug alone.

What research shows

  • Cagrilintide alone, phase 2 RCT (n=706, 26 weeks, Lancet 2021): weight change −6.0% to −10.8% across 0.3–4.5 mg vs −3.0% placebo and −9.0% with liraglutide 3 mg.
  • REDEFINE 1, phase 3 RCT (n=3,417, 68 weeks, NEJM 2025): CagriSema 2.4/2.4 mg −20.4% vs −3.0% placebo (treatment-policy); about −22.7% on-treatment.
  • REDEFINE 2, phase 3 RCT in type 2 diabetes (n=1,206, 68 weeks): −13.7% vs −3.4% placebo; 74% reached HbA1c ≤6.5%.
  • REDEFINE 4, open-label head-to-head vs tirzepatide 15 mg (84 weeks, Feb 2026): 23.0% weight loss with CagriSema vs 25.5% with tirzepatide (efficacy estimand); it failed the primary non-inferiority endpoint.

Doses studied in people

Study or labelDose usedSource
Phase 2 RCT, cagrilintide alone (n=706)0.3, 0.6, 1.2, 2.4, or 4.5 mg once weekly, subcutaneous, 26 weeks1
REDEFINE 1 phase 3 RCT (n=3,417)Cagrilintide 2.4 mg + semaglutide 2.4 mg once weekly, subcutaneous, 68 weeks2
REDEFINE 2 phase 3 RCT in type 2 diabetes (n=1,206)Cagrilintide 2.4 mg + semaglutide 2.4 mg once weekly, 68 weeks2

No approved dose exists; listed doses are from published phase 2 and phase 3 trials only.

Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.

Weekly protocol

How the schedule looks week by week. Each chart says where it comes from: a prescribing label, a clinical trial, or a protocol commonly reported online.

Phase 2 dose-finding trial (4.5 mg arm)

Clinical trial

One week

D1D2D3D4D5D6D7

Once weekly · Subcutaneous injection

Syringe units (U-100)

Dose by week

0.6 mgwk 1–2
1.2 mgwk 3–4
2.4 mgwk 5–6
4.5 mgMaintenance · wk 7–26

Supplies for one course (estimate)

Counts only. This site does not sell or link to supplies.

Course
26 weeks
Note
Doses started at 0.6 mg and rose every 2 weeks, reaching 4.5 mg after week 6; intermediate steps follow the trial's dose levels (full table in the paper's appendix). Investigational; not approved.
Source
Lau DCW et al. Once-weekly cagrilintide for weight management: a dose-finding phase 2 trial. Lancet 2021

Reference only, not a recommendation. Label and trial schedules were set for specific patients under medical supervision. Use the calculator only to understand the arithmetic.

Vial math

Many research vials hold 5 or 10 mg of powder. This table shows how much ends up in each mark on a U-100 insulin syringe for common amounts of added liquid. It is arithmetic only, not a dose.

VialLiquid addedConcentrationPer unit (0.01 mL)
5 mg1 mL5 mg/mL50 mcgOpen in calculator
5 mg2 mL2.5 mg/mL25 mcgOpen in calculator
5 mg3 mL1.67 mg/mL16.7 mcgOpen in calculator
10 mg1 mL10 mg/mL100 mcgOpen in calculator
10 mg2 mL5 mg/mL50 mcgOpen in calculator
10 mg3 mL3.33 mg/mL33.3 mcgOpen in calculator

More sizes: all vial sizes · How this works: Syringes and units · Reconstitution guide.

Safety

  • Gastrointestinal side effects were very common: 80% with CagriSema vs 40% with placebo in REDEFINE 1.
  • Cagrilintide alone caused dose-related injection-site reactions (43% at 4.5 mg vs 3% placebo) in phase 2.
  • Stopping due to side effects with cagrilintide alone was 2–6% vs 3% on placebo (phase 2).
  • As it contains semaglutide, CagriSema would be expected to carry GLP-1 class warnings; long-term safety is not established.

Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.

History

Developed by Novo Nordisk. Phase 2 dose-finding results for cagrilintide alone were published in The Lancet in November 2021. The phase 3 REDEFINE program for CagriSema reported in 2024–2025 and was published in NEJM in June 2025. Novo announced on December 18, 2025 that it had submitted a New Drug Application to FDA. In February 2026 the head-to-head REDEFINE 4 trial missed its goal of proving CagriSema non-inferior to tirzepatide 15 mg; a September 2026 headline reported that CagriSema beat tirzepatide on weight loss in the REIMAGINE 5 trial (details not verified).

Common questions

Is cagrilintide or CagriSema FDA-approved?

No. Novo Nordisk submitted a New Drug Application for CagriSema in December 2025, and no FDA decision had been found as of October 25, 2026 43.

What does the research show?

In REDEFINE 1 (3,417 people, 68 weeks), CagriSema led to 20.4% average weight loss vs 3.0% on placebo 2. Cagrilintide alone gave 6.0% to 10.8% loss over 26 weeks in a phase 2 trial 1.

How does CagriSema compare to tirzepatide?

In the head-to-head REDEFINE 4 trial, weight loss was 23.0% with CagriSema vs 25.5% with tirzepatide 15 mg 5. It missed its main goal of showing it was not worse than tirzepatide 5.

What doses were studied?

Phase 3 trials used cagrilintide 2.4 mg plus semaglutide 2.4 mg once weekly by injection 2. Cagrilintide alone was tested at 0.3 to 4.5 mg weekly in phase 2 1. There is no approved dose.

What are the side effects?

Stomach side effects affected 80% on CagriSema vs 40% on placebo in REDEFINE 1 2. Cagrilintide alone caused more injection-site reactions at higher doses, 43% at 4.5 mg vs 3% on placebo 1.

Can cagrilintide be compounded?

No. FDA has said cagrilintide is an investigational ingredient that cannot be used in compounding 6.

Sold in blends and stacks

CagriSema (cagrilintide + semaglutide)

Related compounds

Metabolic & weightFDA-approvedFlashcard

Semaglutide

Wegovy · Ozempic

Semaglutide is a long-acting copy of the gut hormone GLP-1.

Metabolic & weightFDA-approvedFlashcard

Tirzepatide

Zepbound · Mounjaro

Tirzepatide is a weekly shot that acts on two gut-hormone receptors, GIP and GLP-1, at once.

Metabolic & weightLate-stage trialsFlashcard

Retatrutide

LY3437943 · triple agonist

Retatrutide is an experimental weekly shot from Eli Lilly that acts on three hormone receptors: GIP, GLP-1, and glucagon.

Sources

  1. Lau DCW et al. Once-weekly cagrilintide for weight management: phase 2 trial. Lancet 2021 Journal
  2. REDEFINE 1 and REDEFINE 2 journal scan (ACC; NEJM 2025, Garvey et al. and Davies et al.) Journal
  3. CagriSema FDA Approval Status and timeline (Drugs.com) Regulatory
  4. Novo Nordisk submits NDA to FDA for CagriSema (PharmExec, Dec 2025) Regulatory
  5. CagriSema REDEFINE 4 head-to-head: primary endpoint not achieved (Novo press release) Regulatory
  6. FDA's Latest GLP-1 Crackdown (Venable, Mar 2026) Regulatory

Last reviewed 2026-10-25 · How we research · Found an error? See our corrections policy.