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Guide

How is cagrilintide dosed?

Cagrilintide alone has no approved product and no dedicated, completed Phase 3 trial of its own. Its human evidence is the cagrilintide-only arm inside REDEFINE 1 — a trial built primarily to test the CagriSema combination — plus one completed Phase 2 dose-finding trial. Every figure below is checked against the arm that actually produced it.

Topic: Reading what has actually been studied for cagrilintide alone, kept separate from CagriSema

Audience: Anyone comparing a cagrilintide dose figure against what was actually studied

Reading time: 8–10 minutes

No approved product, no dedicated completed Phase 3

Cagrilintide has not been approved by the FDA, EMA, or any regulatory body, alone or as CagriSema. Every figure on this page is a fact about a specific study and its specific arm — not a recommendation, and never a CagriSema result presented as cagrilintide's own.

On this page
  1. 1.Cagrilintide alone, not CagriSema
  2. 2.REDEFINE 1's cagrilintide-alone arm
  3. 3.The Phase 2 dose-finding trial
  4. 4.A half-life, read directly
  5. 5.Is there a community-reported dose?
  6. 6.Compounding position
  7. 7.Related pages
  8. 8.FAQ
  9. 9.References

Cagrilintide alone, not CagriSema

Cagrilintide is a long-acting amylin analogue, developed by Novo Nordisk, studied for effects on appetite and body weight through amylin receptor agonism. CagriSema is a separate, fixed-dose combination of cagrilintide and semaglutide, currently under FDA review as its own investigational product — not an approved brand name, and not the subject of this page. The cagrilintide profile covers the mechanism in more depth; the CagriSema guide covers the combination's own trial evidence directly. This page exists specifically to read cagrilintide's own evidence, and to never let a combination-product result stand in for it.

The evidence below is ordered the way the site's own convention places it: human trials first, with each trial's exact arm and design stated, then a genuinely sourced pharmacokinetic figure, then community-reported practice last, attributed and marked unverified.

REDEFINE 1’s cagrilintide-alone arm

REDEFINE 1 — Cagrilintide-Alone Arm

NCT05567796

COMPLETED (results published in NEJM); cagrilintide-alone arm is a secondary comparator within a Phase 3 trial built primarily to test CagriSema

Design: Phase 3, 68-week (16-week dose escalation + 52-week maintenance), randomized, double-blind, placebo- and active-controlled trial in adults without diabetes, BMI ≥30 or ≥27 with a weight-related complication.

Arms: 3,417 total participants randomized 21:3:3:7 to CagriSema (N=2,108), semaglutide alone (N=302), cagrilintide alone (N=302), or placebo (N=705).

Endpoint reported: CagriSema vs. placebo (both directly, cleanly confirmed from the paper's own text): treatment-policy estimand, -20.4% vs. -3.0% (estimated difference -17.3 percentage points, 95% CI -18.1 to -16.6, p<0.001); trial-product estimand, -22.7% vs. -2.3% (estimated difference -20.4 percentage points). Cagrilintide-alone's own specific figure: not confirmed by Prof. Peptide to a clean primary-source sentence — see the grade below.

Attributed for the trial's own design, dates, and per-arm N, and for the CagriSema-vs-placebo comparison (both read directly from the primary paper). The cagrilintide-alone arm's specific percentage is reported as secondary-sourced only, not independently verified against the primary paper's own clearly labeled figure.

Adverse events were reported alongside these dosing arms in the same trial: gastrointestinal reactions were the most frequently reported adverse event category across all four arms, including cagrilintide alone and the semaglutide-containing arms, consistent with the GI effects reported for both the amylin and GLP-1 mechanism classes.

The Phase 2 dose-finding trial

Phase 2 Dose-Finding Monotherapy Trial (Lau et al. 2021)

NCT03856047

COMPLETED

Design: Phase 2, 26-week, multicenter, randomized, double-blind, placebo-controlled and active-controlled, dose-finding trial.

Arms: 706 adults with overweight or obesity randomized to one of five cagrilintide doses (0.3, 0.6, 1.2, 2.4, or 4.5 mg once weekly), matched placebo, or an active comparator arm of liraglutide 3.0 mg once daily.

Endpoint reported: Read directly from the primary paper's own abstract (Lancet, PMID 34798060): mean percentage weight reduction across all five cagrilintide doses (0.3-4.5 mg) ranged 6.0%-10.8%, versus 3.0% for placebo (trial product estimand), with the 4.5 mg dose specifically confirmed at 10.8%. The abstract does not break out the 2.4 mg dose's own figure; secondary coverage of the trial reports approximately 9.7% at 2.4 mg, a figure consistent with the primary paper's stated range but not independently confirmed by Prof. Peptide against the paper's own dose-by-dose table.

Attributed for the trial's own design, registered arms, dates, and the overall dose-range and 4.5 mg/placebo figures (all read directly from the primary paper's abstract, PMID 34798060). The specific 2.4 mg figure is reported as secondary-sourced only.

This is the trial cagrilintide's own dose-escalation convention traces to — the five doses studied (0.3, 0.6, 1.2, 2.4, 4.5 mg) are the same figures that appear in community-reported protocols below.

A half-life, read directly

The cagrilintide profile now carries a sourced monotherapy half-life. Nielsen et al. 2026 (Clin Pharmacokinet, PMID 42228334) reports 186 hours (normal renal function) and 174 hours (normal hepatic function) for cagrilintide given alone — more specific than the co-administered figure below, since it isolates cagrilintide from semaglutide.

Enebo et al. 2021 — Cagrilintide/Semaglutide Co-administration PK Trial

Enebo LB, Berthelsen KK, Kankam M, et al. Lancet. 2021;397(10286):1736-1748. NCT03600480.

Reported directly in the paper: “Cagrilintide 0·16–4·5 mg had a half-life of 159–195 h, with a median tmax of 24–72 h.” The discussion states: “The elimination half-life of cagrilintide was around 7–8 days, with maximum exposure 24–25 h after administration, making it suitable for once-weekly dosing.”

Measured during co-administration with semaglutide 2.4 mg, not cagrilintide given alone. The paper states semaglutide's own exposure and elimination were unaffected by concomitant cagrilintide; it does not state the reverse claim for cagrilintide's own pharmacokinetics.

Is there a community-reported dose?

Yes — 0.16, 0.30, 0.60, 1.20, or 2.40 mg once weekly via subcutaneous injection, escalating roughly every 4 weeks, is the figure reported on Prof. Peptide’s own cagrilintide profile as the common research-grade convention. It mirrors the exact dose steps studied in the Phase 2 dose-finding trial above, though the correspondence is reported here as an observation, not as evidence that the community protocol was derived from that trial’s own escalation schedule.

It is reported below the trial and pharmacokinetic evidence above, as observed practice attributed to where it circulates — not independently verified by Prof. Peptide, and not derived from either trial's own protocol documentation.

Compounding position

Cagrilintide does not appear on FDA's bulk drug substances page at all.

Checked directly against FDA's own bulk-substance safety-risk page: cagrilintide is absent from both the active Category list and the 503A nominated-but-withdrawn table — unlike several other compounds covered elsewhere on this site, it has apparently never been formally nominated to either bulks list at all.

Separately, FDA has taken direct enforcement action naming it: a warning letter to Prime Sciences (721805, dated March 31, 2026, following a website review from January to March 2026) quotes the vendor's own cagrilintide marketing claims among the products the letter identifies as unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act.

Research-grade cagrilintide, of the kind sold by the vendors Prof. Peptide tracks elsewhere on this site, is neither an approved product nor a verified lawfully compounded one under the position above. It is sold labeled for laboratory research use, not for human administration, and it is not dispensed against a prescription.

FAQ

Is cagrilintide the same as CagriSema?
No. Cagrilintide is a single molecule, a long-acting amylin analogue. CagriSema is Novo Nordisk's fixed-dose combination of cagrilintide and semaglutide, currently under FDA review as its own investigational product. A result from CagriSema describes both molecules acting together and is never the same as a result from cagrilintide given alone — see the CagriSema guide for the combination's own trial evidence.
Does cagrilintide have an approved product?
No. Neither cagrilintide alone nor CagriSema has been approved by the FDA as of this page's last check. Cagrilintide also has no dedicated, completed Phase 3 trial of its own — its human evidence comes from the cagrilintide-only arm inside REDEFINE 1 (a Phase 3 trial built primarily to test CagriSema) and one completed Phase 2 monotherapy dose-finding trial.
What did REDEFINE 1's cagrilintide-alone arm show?
REDEFINE 1 (NCT05567796) randomized 302 of its 3,417 total participants to cagrilintide alone at 2.4 mg once weekly, alongside larger arms for the CagriSema combination, semaglutide alone, and placebo, over 68 weeks. The trial's own published paper (NEJM) reports the CagriSema-vs-placebo comparison in exact, clearly labeled figures under two estimands. The cagrilintide-alone arm's own precise percentage appears only inside a bar-chart figure that could not be read with confidence from the available text extraction; convergent secondary coverage of the trial reports a figure in the range of roughly 11-12% weight reduction for cagrilintide alone at week 68, which this page reports as secondary-sourced, not independently confirmed against the primary paper's own clearly labeled text.
What did the Phase 2 dose-finding trial show?
NCT03856047 (Lau et al., Lancet, 2021, PMID 34798060) randomized 706 adults with overweight or obesity to one of five cagrilintide doses (0.3-4.5 mg once weekly), placebo, or an active comparator (liraglutide 3.0 mg once daily), over 26 weeks. Read directly from the paper's own abstract: mean weight reduction across all five cagrilintide doses ranged 6.0%-10.8%, versus 3.0% for placebo, with the 4.5 mg dose specifically confirmed at 10.8%. The abstract does not break out the 2.4 mg dose on its own; secondary coverage reports approximately 9.7% at that dose, consistent with the paper's stated range but not independently confirmed against its dose-by-dose table.
Does cagrilintide have a published half-life?
Yes — read directly from a primary source for this page, since Prof. Peptide's own half-life module currently carries no sourced figure for cagrilintide. Enebo et al. (Lancet, 2021, NCT03600480) reports cagrilintide had a half-life of 159-195 hours across the 0.16-4.5 mg dose range studied, and states in its discussion that cagrilintide's elimination half-life was around 7-8 days. One caveat: this was measured during co-administration with semaglutide 2.4 mg, not cagrilintide given alone.
What is the compounding position on cagrilintide?
Checked directly against FDA's own bulk drug substances page: cagrilintide does not appear on it at all, in either the active Category list or the nominated-but-withdrawn table. Separately, an FDA warning letter to Prime Sciences (dated March 31, 2026) quotes the vendor's own cagrilintide marketing claims among products the letter identifies as unapproved new drugs.

References

  1. ClinicalTrials.gov. Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once-weekly in Participants With Overweight or Obesity (REDEFINE 1), NCT05567796. https://clinicaltrials.gov/study/NCT05567796
  2. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1). N Engl J Med. DOI 10.1056/NEJMoa2502081. https://www.nejm.org/doi/full/10.1056/NEJMoa2502081
  3. ClinicalTrials.gov. Investigation of Safety and Efficacy of NNC0174-0833 (cagrilintide) for Weight Management — a Dose Finding Trial, NCT03856047. https://clinicaltrials.gov/study/NCT03856047
  4. Lau DCW, et al. 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;398(10317):2160-2172. PMID 34798060. https://pubmed.ncbi.nlm.nih.gov/34798060/
  5. Enebo LB, Berthelsen KK, Kankam M, et al. 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;397(10286):1736-1748. https://clinicaltrials.gov/study/NCT03600480
  6. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  7. U.S. Food and Drug Administration. Warning Letter: Prime Sciences, 721805, 2026-03-31. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026
  8. Nielsen MJF, Becker NP, Duus HHH, et al. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet. 2026;65(7):1087-1099. PMID 42228334. https://pubmed.ncbi.nlm.nih.gov/42228334/

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