CagriSema vs Semaglutide: REDEFINE Results and Status
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[GLP-1 · Comparison]

CagriSema vs semaglutide: what does adding cagrilintide do?

REDEFINE 1 · REIMAGINE 2 · FDA status · Half-life

Short answer: CagriSema is weekly semaglutide 2.4 mg plus the amylin analog cagrilintide 2.4 mg. In REDEFINE 1, adults without diabetes lost 20.4% of body weight at 68 weeks on CagriSema versus 14.9% on semaglutide alone.1 Novo Nordisk submitted CagriSema to FDA in December 2025; as of October 2026 it is not approved.2

Unlike most pipeline comparisons, CagriSema has been tested against semaglutide inside the same randomized trials, so the numbers below are real side-by-side results. Note that each trial reports two numbers: one counting everyone randomized, one as if everyone stayed on treatment.

How do CagriSema and semaglutide compare side by side?

Semaglutide from the US labels; CagriSema from published trials and Novo Nordisk filings. Checked October 2026.
CagriSema (cagrilintide + semaglutide)Semaglutide (Wegovy, Ozempic)
MechanismAmylin analog (cagrilintide) plus GLP-1 receptor agonist (semaglutide)3GLP-1 receptor agonist4
Approval statusInvestigational; submitted to FDA December 2025, decision expected late 20262FDA approved: Ozempic (type 2 diabetes), Wegovy (weight management)4
Dose studied / label doseStudied: cagrilintide 2.4 mg + semaglutide 2.4 mg once weekly, with flexible dosing allowed in REDEFINE 131Wegovy label: 0.25 mg weekly, stepped up every 4 weeks to 1.7 or 2.4 mg, up to 7.2 mg4
Half-lifeCagrilintide about 7 days (phase 1b: 159 to 195 hours)5about 7 days (label: about 1 week)6
Time to peak (Tmax)Cagrilintide median 24 to 72 hours in phase 1b51 to 3 days (label)6
Weight change, REDEFINE 1 (68 weeks, no diabetes)−20.4% (everyone randomized); −22.7% (if on treatment)1Semaglutide 2.4 mg arm: −14.9%; −16.1%1
Weight change, REIMAGINE 2 (68 weeks, type 2 diabetes)−12.9% (everyone randomized); −14.2% (if on treatment)7Semaglutide 2.4 mg arm: −9.2%; −10.2%7
HbA1c change, REIMAGINE 2−1.80 points (everyone randomized)7−1.68 points7
Notable warningsNo label yet. GI events in 79.6% on CagriSema vs 39.9% on placebo in REDEFINE 1, mostly mild to moderate3Boxed thyroid C-cell tumor warning; pancreatitis, gallbladder disease, kidney injury4

Reviewed . Half-life figures are shown only where the value Dose Track uses agrees with the cited source.

What did REDEFINE 1 show against semaglutide alone?

REDEFINE 1 was a 68-week, double-blind phase 3a trial in 3,417 adults with obesity, or overweight with a related condition, and no diabetes. People were randomized 21:3:3:7 to CagriSema, semaglutide 2.4 mg, cagrilintide 2.4 mg or placebo.3 The main comparison was against placebo; the single-drug arms were smaller (302 people each).

  • Counting everyone randomized: −20.4% on CagriSema, −14.9% on semaglutide, −11.5% on cagrilintide, −3.0% on placebo.1
  • If everyone stayed on treatment: −22.7%, −16.1%, −11.8% and −2.3%.1
  • Dose at week 68: the protocol let people change dose. 57.3% on CagriSema were on the top dose, versus 70.2% on semaglutide.1

REDEFINE 2 tested CagriSema against placebo only (no semaglutide arm) in 1,206 adults with type 2 diabetes: −13.7% vs −3.4% at 68 weeks.8

What about people with type 2 diabetes?

REIMAGINE 2 (2,728 adults with type 2 diabetes on metformin, with or without an SGLT2 inhibitor, 68 weeks) did include a semaglutide 2.4 mg arm. Counting everyone randomized, weight fell 12.9% on CagriSema vs 9.2% on semaglutide, and HbA1c fell 1.80 vs 1.68 points. Novo Nordisk reports both differences as statistically significant.7 These are company-reported results.

Is CagriSema approved?

Not as of October 2026. Novo Nordisk submitted CagriSema for weight management to FDA in December 2025, based on REDEFINE 1 and 2, and expects a decision by late 2026.2 A cardiovascular outcomes trial, REDEFINE 3, randomized 7,076 adults with established heart disease and is still running.9

In REDEFINE 4, an 84-week open-label trial against tirzepatide 15 mg in 809 people, CagriSema did not meet its goal of showing non-inferiority: −20.2% vs −23.6% counting everyone randomized.2

This page summarizes labels and published studies. It is not personalized medical advice; confirm any dose or change with your prescriber.
Retatrutide vs semaglutide: how do they compare?Triple vs single agonist, trials, approval status Semaglutide vs tirzepatide: what did the head-to-head trial show?SURMOUNT-5 results, label titration, half-life Orforglipron vs semaglutide: how do the GLP-1 pills compare?ACHIEVE-3 head-to-head, food rules, label dosing

Frequently asked questions

Does CagriSema work better than semaglutide alone?+
In REDEFINE 1, average weight change at 68 weeks was −20.4% on CagriSema and −14.9% on semaglutide 2.4 mg alone, counting everyone randomized. These are group averages from adults without diabetes; individual results vary.1
What is in CagriSema?+
Two drugs given together once a week: cagrilintide 2.4 mg, a long-acting amylin analog, and semaglutide 2.4 mg, the same GLP-1 drug as in Wegovy.3
Is CagriSema FDA approved?+
No. It was submitted to FDA in December 2025 and Novo Nordisk expects a decision by late 2026.2
Are the side effects worse than semaglutide?+
In REDEFINE 1, gastrointestinal side effects affected 79.6% on CagriSema vs 39.9% on placebo, mostly mild to moderate and short-lived.3 The published abstract does not give the semaglutide-alone rate, so we do not compare them here.
Can I track cagrilintide and semaglutide in Dose Track?+
Yes. Both are built in, with their half-lives, so you can log each shot and see estimated levels of both on one chart.

Sources

  1. Novo Nordisk. CagriSema demonstrates superior weight loss in adults with obesity or overweight in the REDEFINE 1 trial. Company announcement No 99/2024 (Form 6-K), December 20, 2024.
  2. Novo Nordisk. REDEFINE 4 head-to-head trial vs tirzepatide; FDA submission status. Company announcement No 13/2026 (Form 6-K), February 23, 2026.
  3. Garvey WT, et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1). N Engl J Med. 2025;393:635-647.
  4. Wegovy (semaglutide) injection and tablets prescribing information. DailyMed, revised June 2026.
  5. Enebo LB, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of cagrilintide with semaglutide 2.4 mg: a phase 1b trial. Lancet. 2021.
  6. Ozempic (semaglutide) injection prescribing information. DailyMed, revised June 2026.
  7. Novo Nordisk. CagriSema demonstrated superior HbA1c reduction and weight loss vs semaglutide in adults with type 2 diabetes in the REIMAGINE 2 trial. Company announcement, February 2, 2026.
  8. Davies MJ, et al. Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2). N Engl J Med. 2025;393:648-659.
  9. Design and baseline characteristics of the CagriSema cardiovascular outcomes trial (REDEFINE 3). Am Heart J. 2026.

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