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    CagriSema (cagrilintide and semaglutide)

    Also known as cagrilintide-semaglutide, cagrilintide/semaglutide

    CagriSema is Novo Nordisk's investigational weekly combination of cagrilintide, a long-acting amylin analogue, and semaglutide.[1] It produced 20.4% average weight loss in REDEFINE 1 but missed non-inferiority against tirzepatide in REDEFINE 4. An FDA decision is expected by late 2026.[2][3][4]

    Editor reviewedStrict sourcingUpdated GLP-1 and metabolic medicineHealth and medicineLife sciences
    Key facts

    CagriSema is a novo-nordisk obesity candidate that builds on semaglutide. It pairs semaglutide with a second hormone mimic, cagrilintide, a long-acting analogue of amylin, in one weekly injection.[1]

    REDEFINE 1 and 2

    REDEFINE 1 randomised 3,417 adults with obesity or overweight, without diabetes, to CagriSema, either component alone, or placebo for 68 weeks. CagriSema produced a mean 20.4% weight loss versus 3.0% on placebo.[2] REDEFINE 2 tested the same 2.4 mg/2.4 mg dose in 1,206 adults with type 2 diabetes and overweight or obesity. They lost a mean 13.7% of body weight at 68 weeks versus 3.4% on placebo, and 73.5% reached an HbA1c of 6.5% or less, versus 15.9%.[5] Novo filed CagriSema with the FDA in December 2025 on the basis of REDEFINE 1 and REDEFINE 2.[4]

    The tirzepatide comparison

    In REDEFINE 4, an open-label 84-week trial, CagriSema was compared directly with tirzepatide 15 mg. Weight loss was 20.2% with CagriSema versus 23.6% with tirzepatide under the treatment-regimen estimand. The trial did not meet its primary endpoint of non-inferiority.[3] In type 2 diabetes, the REIMAGINE 4 trial found CagriSema non-inferior to tirzepatide for weight reduction but not for blood-sugar (HbA1c) reduction.[6]

    Diabetes trials

    The REIMAGINE programme tests CagriSema as a type 2 diabetes treatment. In REIMAGINE 3, published in The Lancet in June 2026, CagriSema was added to basal insulin. After 40 weeks HbA1c fell by 2.33 percentage points at 2.4 mg/2.4 mg and 2.10 at 1.0 mg/1.0 mg, versus 0.66 with placebo. Body weight fell 10-12%, and no severe hypoglycaemia was reported.[7]

    On 21 September 2026 Novo reported topline results from two more trials of the lower 1.0 mg/1.0 mg dose. In REIMAGINE 5, in type 2 diabetes, CagriSema produced 12.4% weight loss versus 9.1% with tirzepatide 5 mg, with non-inferior HbA1c reduction. In REDEFINE 9, in obesity, it produced 21.0% weight loss versus 2.0% with placebo.[8] These are company topline figures reported in trade press, not yet peer-reviewed. The tirzepatide comparator in REIMAGINE 5 was its lowest dose.[8]

    Regulatory status

    As of October 2026 CagriSema is investigational. Novo anticipates an FDA decision by late 2026.[4] Novo has completed a phase 3 trial of lower CagriSema doses (REDEFINE 9) and started a phase 3 trial of a higher dose.[9]

    The amylin field

    Cagrilintide is one of several amylin-based approaches being combined with GLP-1 drugs. Pfizer’s November 2025 purchase of Metsera included contingent payments tied to a combination of Metsera’s monthly GLP-1 candidate MET-097i with its amylin analogue MET-233i.[10] Such combinations add a second hormone pathway on top of GLP-1 activity, which CagriSema does in a fixed-dose weekly product.[1] eli-lilly is testing its own amylin approach: it reported in September 2026 that eloralintide plus tirzepatide produced up to 23.3% weight loss versus 14.8% with tirzepatide 15 mg alone in a 48-week phase 2b trial in type 2 diabetes, and said phase 3 would start in Q4 2026.[11]

    Why it matters

    If approved, CagriSema’s commercial position will depend on how it compares with tirzepatide and with Lilly’s retatrutide, which Lilly plans to file in 2027.[3][12]

    Questions readers ask

    What is in CagriSema?

    Cagrilintide is a long-acting amylin analogue. CagriSema combines it with semaglutide in a single fixed-dose weekly treatment.[1]

    Did CagriSema beat tirzepatide?

    No. In REDEFINE 4, CagriSema produced 20.2% weight loss versus 23.6% with tirzepatide 15 mg at 84 weeks (treatment-regimen estimand), and the trial missed its non-inferiority endpoint.[3]

    When could CagriSema be approved?

    Novo Nordisk submitted it to the FDA in December 2025 and anticipates a decision by late 2026. It was not approved as of October 2026.[4]

    Has CagriSema ever beaten tirzepatide?

    In REIMAGINE 5, reported by Novo in September 2026 as topline data, CagriSema 1.0 mg/1.0 mg produced 12.4% weight loss versus 9.1% with tirzepatide 5 mg, the lowest tirzepatide dose, in type 2 diabetes. At the top tirzepatide dose (REDEFINE 4) it did not.[8][3]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      CagriSema is a fixed-dose combination of cagrilintide 2.4 mg, a long-acting amylin analogue, and semaglutide 2.4 mg. confirmedas of 2026-10-10

    2. [2]

      In the REDEFINE 1 trial of 3,417 adults randomised to CagriSema, either component alone or placebo, CagriSema produced a mean 20.4% weight loss at 68 weeks versus 3.0% with placebo. confirmedas of 2025-06-22

    3. [3]

      On 23 February 2026 Novo Nordisk reported that CagriSema failed to show non-inferiority to tirzepatide 15 mg in the open-label REDEFINE 4 trial, with weight loss of 20.2% versus 23.6% at 84 weeks under the treatment-regimen estimand. confirmedas of 2026-02-23

    4. [4]

      Novo Nordisk submitted CagriSema to the US FDA in December 2025 based on REDEFINE 1 and 2, with a decision anticipated by late 2026. confirmedas of 2026-09-21

    5. [5]

      In REDEFINE 2, 1,206 adults with type 2 diabetes and overweight or obesity lost a mean 13.7% of body weight at 68 weeks on CagriSema versus 3.4% on placebo, and 73.5% reached HbA1c of 6.5% or less versus 15.9%. confirmedas of 2025-06-22

    6. [6]

      In the REIMAGINE 4 trial in type 2 diabetes, CagriSema was non-inferior to tirzepatide 15 mg for weight reduction but not for HbA1c reduction. confirmedas of 2026-08-04

    7. [7]

      In REIMAGINE 3, CagriSema added to basal insulin in type 2 diabetes lowered HbA1c by 2.33 and 2.10 percentage points at the 2.4 mg and 1.0 mg doses versus 0.66 with placebo at 40 weeks, with 10-12% weight reduction and no severe hypoglycaemia. confirmedas of 2026-06-07

    8. [8]

      Novo Nordisk reported topline results on 21 September 2026 in which CagriSema 1.0 mg/1.0 mg produced 12.4% weight loss versus 9.1% with tirzepatide 5 mg in type 2 diabetes (REIMAGINE 5), and 21.0% versus 2.0% with placebo in obesity (REDEFINE 9). reportedas of 2026-09-21

    9. [9]

      By mid-2026 Novo Nordisk had completed the REDEFINE 9 phase 3 trial of lower CagriSema doses and initiated a phase 3 trial of high-dose CagriSema in obesity. confirmedas of 2026-08-04

    10. [10]

      Pfizer completed its acquisition of obesity-drug developer Metsera on 13 November 2025 at about $7.0 billion enterprise value plus contingent payments tied to its monthly injectable GLP-1 candidate MET-097i and amylin analogue MET-233i. confirmedas of 2025-11-13

    11. [11]

      Lilly reported on 30 September 2026 that in a 48-week phase 2b trial in 367 adults with obesity and type 2 diabetes, its eloralintide (amylin agonist) plus tirzepatide combination produced up to 23.3% weight loss versus 14.8% with tirzepatide 15 mg alone, and that phase 3 trials would start in Q4 2026. reportedas of 2026-09-30

    12. [12]

      As of August 2026, Lilly said three additional phase 3 retatrutide obesity trials were positive, that the data package was complete for obesity, obstructive sleep apnea and knee osteoarthritis pain, and that it plans to submit a Biologics License Application to the FDA in the first quarter of 2027. confirmedas of 2026-08-05

    Revision history (2)
    1. Page created.
    2. Refresh: added REDEFINE 2 and REIMAGINE 3 results, September 2026 topline results from REIMAGINE 5 and REDEFINE 9, and competing amylin combinations.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "CagriSema (cagrilintide and semaglutide)." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/cagrisema

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