Cagrilintide

No product containing cagrilintide is approved in the United States. FDA states that cagrilintide cannot be used in compounding under federal law, that it is not a component of any FDA-approved drug, and that it has not been found safe and effective for any condition. The trials recorded on this page are sponsored investigational studies, and a registered trial is not an approval.^[4]

Jurisdiction

United States

Product

Cagrilintide, investigational; no approved product, alone or in combination

Indication

No FDA-approved indication; FDA states cagrilintide may not be used in compounding and is not a component of an approved drug

Record date

2026-09-08

• This is a United States status. It says nothing about the status of cagrilintide in any other jurisdiction.
• Whether a marketing application for the cagrilintide and semaglutide combination has been filed with FDA, and when a decision might follow, could not be established. FDA does not publish pending applications; a search of the Drugs@FDA application dataset on September 9, 2026, repeated independently the same day during editorial review, returned no application for cagrilintide; and no regulator document stating a filing date was found. Any filing date or expected decision date circulating elsewhere is unverified here.
• That a substance is not approved is a statement about the regulatory record. It is neither evidence that it is unsafe nor evidence that it works.
• The recorded date is the date through which the status was confirmed still current, capped at the evidence cutoff. It is not the date of the cited document.

Cagrilintide is an injected amylin receptor agonist. It is not a GLP-1 receptor agonist, and the trials inspected here study it mainly in combination with the GLP-1 receptor agonist semaglutide rather than on its own. That combination is a separate product, called CagriSema: the trial reports describe it as coadministration of cagrilintide and semaglutide, and the blood-pressure analysis of the same trial describes it as a fixed-dose combination of the two at 2.4 mg each. Of the three trials inspected here, only REDEFINE 1 included an arm receiving cagrilintide alone; the fourth source is a later analysis of REDEFINE 1 rather than a separate trial.^[1][2][3]

• The two sources describe the combination differently, as coadministration in the trial report and as a fixed-dose combination in the later analysis of the same trial. Both descriptions are recorded rather than reconciled; no manufacturing or formulation document was inspected.
• Because most of the inspected evidence studies the combination, findings from it describe cagrilintide together with semaglutide and cannot be attributed to cagrilintide alone.
• CagriSema is carried as a search alias on this record so that readers looking for the combination find the evidence. It is the name of the combination product, not a second name for cagrilintide.

Gastrointestinal events were reported by a large majority of the participants who received the cagrilintide and semaglutide combination in the two inspected REDEFINE trials, and both trial abstracts describe them as mainly transient and mild to moderate. In REDEFINE 1 they affected 79.6% of participants on the combination and 39.9% on placebo, and in REDEFINE 2 they were reported by 72.5% on the combination and 34.4% on placebo. In the blood-pressure analysis of REDEFINE 1, hypotension was reported in 38 participants (1.8%) on the combination and 3 (0.4%) on placebo, and that analysis describes reporting of blood-pressure-related events as slightly higher on the combination than in the other groups but generally low across all groups.^[1][5][3]

• These are safety figures for cagrilintide given with semaglutide, not for cagrilintide alone. The cross-arm comparison the trial itself makes, including discontinuations for gastrointestinal events and injection-site reactions by arm, is in the REDEFINE 1 full text, which could not be reached: the publisher returned HTTP 403, there is no PubMed Central copy, and the trial registration has no posted results. That comparison is an open gap on this record.
• Two of the three sources were inspected as abstracts, so the adverse-event tables were not read.
• Reported adverse events describe what happened to participants under trial conditions. They do not establish causation for any individual event or a rate outside these trials.
• The hypotension figures come from a secondary analysis whose supplementary table was not inspected; the numbers here are those stated in the Safety section's own text.

In REDEFINE 1, a 68-week phase 3a trial, 3,417 adults with overweight and a coexisting condition or with obesity, and without diabetes, were randomized to cagrilintide-semaglutide, to semaglutide alone, to cagrilintide alone, or to placebo, with lifestyle intervention in every group. The estimated mean change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide against -3.0% with placebo, an estimated difference of -17.3 percentage points (95% confidence interval -18.1 to -16.6). Participants receiving the combination were more likely than those receiving placebo to reach weight-loss thresholds of at least 5%, 20%, 25% and 30%.^[1]

• These are results for the combination against placebo. The abstract does not report the outcomes of the cagrilintide-alone arm, so nothing here describes what cagrilintide achieved by itself.
• Abstract-only inspection: the tables and supplementary appendix were not read, and the trial registration has no posted results.
• The abstract states that the combination beat placebo on the weight-loss thresholds but gives the proportions for none of them, so their size cannot be stated here.
• An industry-funded 68-week trial in adults without diabetes. It reports weight change, not clinical outcomes such as cardiovascular events.

In REDEFINE 2, a 68-week phase 3a trial in 12 countries, 1,206 adults with type 2 diabetes and a body-mass index of 27 or more were randomized in a 3 to 1 ratio to once-weekly cagrilintide-semaglutide or placebo, with lifestyle intervention. The estimated mean change in body weight from baseline to week 68 was -13.7% with the combination and -3.4% with placebo, an estimated difference of -10.4 percentage points (95% confidence interval -11.2 to -9.5). More patients on the combination than on placebo lost at least 5%, and the same held for thresholds of 10%, 15% and 20%. The abstract reports that 73.5% of patients on the combination and 15.9% on placebo had a glycated hemoglobin level of 6.5% or less.^[5]

• This trial had no cagrilintide-alone arm. Everything reported here describes the combination with semaglutide and cannot be attributed to cagrilintide by itself.
• The glycated hemoglobin proportions are reported without a between-group test in the abstract, so they are described proportions rather than a tested end point.
• Abstract-only inspection: the tables and supplementary appendix were not read, and the trial registration has no posted results.
• An industry-funded 68-week trial reporting weight and laboratory measures, not diabetes complications or survival.

REIMAGINE 1 was a 40-week phase 3a study at 42 sites in six countries in which 189 adults with type 2 diabetes inadequately controlled by diet and exercise were randomized to cagrilintide-semaglutide at one of two dose levels or to matching placebo. Baseline mean glycated hemoglobin was 7.8% and mean body-mass index was 35.2 kg/m2. Using the efficacy estimand, the estimated mean change in glycated hemoglobin at week 40 was -1.8 percentage points at the higher dose level, -1.5 at the lower and -0.1 with placebo, giving estimated treatment differences against placebo of -1.7 percentage points (95% confidence interval -2.0 to -1.3) and -1.3 percentage points (-1.8 to -0.9). Estimated mean relative change in body weight was -13.8% and -11.8% against -1.4% with placebo. Adverse events were reported by 79% and 75% of participants on the combination and 66% on placebo, and were described as mostly mild or moderate and gastrointestinal.^[2]

• No cagrilintide-alone arm, so nothing here separates cagrilintide from semaglutide.
• A small study of 189 participants across three groups, selected for early type 2 diabetes managed without glucose-lowering medicines. It does not describe other populations.
• The reported estimates use the efficacy estimand, which describes the effect if treatment is taken as intended, rather than an intention-to-treat estimand.
• Abstract-only inspection: the tables and appendix were not read.

A secondary and post hoc analysis of REDEFINE 1 reported blood pressure for all four randomized groups and is the only inspected source that reports an outcome for the cagrilintide-alone arm. From baseline to week 68, systolic blood pressure fell by 10.9 mm Hg with cagrilintide-semaglutide, by 8.5 mm Hg with semaglutide alone, by 5.2 mm Hg with cagrilintide alone and by 2.8 mm Hg with placebo; against placebo, the estimated treatment difference for cagrilintide alone was -2.4 mm Hg (95% confidence interval -4.1 to -0.8). Diastolic blood pressure fell by 5.4, 4.9, 2.9 and 1.7 mm Hg in the same order, with an estimated difference for cagrilintide alone of -1.3 mm Hg (-2.4 to -0.1). The same analysis reports that the proportion of participants losing at least 20% of body weight was 61.5% with the combination, 29.5% with semaglutide alone and 15.2% with cagrilintide alone. A mediation analysis attributed 72% (95% confidence interval 54 to 91) of the systolic reduction to weight change.^[3]

• The change in systolic blood pressure for the combination against placebo was a prespecified secondary confirmatory end point of a trial designed to test body weight. The comparisons this finding rests on, the cagrilintide-alone and semaglutide-alone groups against placebo, are described by the analysis itself as post hoc, so they are hypothesis-generating rather than confirmatory.
• The single-agent arms had 302 participants each against 2,108 on the combination, so the cagrilintide-alone estimates are far less precise, and their confidence intervals come close to no effect.
• The estimates use the trial-product estimand rather than the treatment-policy estimand used for the trial's primary results, so they are not directly comparable with the trial's headline figures.
• Every treatment difference reported here is against placebo. The inspected passages report no statistical comparison between the combination and either single agent, and the proportions reaching at least 20% weight loss are descriptive figures.
• A mediation analysis is a modelled attribution, not a measured causal decomposition.
• A blood-pressure change is a measurement, not a cardiovascular outcome. No cardiovascular event result was inspected.

Cagrilintide and semaglutide together are not an extrapolation from separate studies: the pair itself has been tested in randomized trials, which is unusual among the combinations described in this reference. REDEFINE 1 randomized 3,417 adults to the combination, to each agent alone, or to placebo, so both single agents were studied as active comparator groups alongside the combination; REDEFINE 2 and REIMAGINE 1 tested the combination against placebo in adults with type 2 diabetes. In the blood-pressure analysis of REDEFINE 1, the combination showed larger reductions in systolic and diastolic blood pressure, and a larger proportion of participants losing at least 20% of body weight, than either agent alone, although each estimate is reported against placebo rather than as a test between the groups. Gastrointestinal adverse events were reported by more participants on the combination than on placebo in both REDEFINE trials. This is evidence about one specific named pair at the doses studied, not about combining amylin and GLP-1 receptor agonists generally.^[1][3][5]

• The arm-by-arm figures come from the blood-pressure analysis of REDEFINE 1, in which the single-agent comparisons against placebo are described as post hoc and blood pressure was not the outcome the trial was designed to test. No statistical comparison of the combination against either single agent was reported in the inspected passages, and the trial's own primary comparison published in its abstract is against placebo only.
• Two of the three sources were inspected as abstracts, so no adverse-event table was read and no comparison of discontinuations between the combination and either single agent could be inspected.
• The trials studied fixed doses of both components. Nothing here describes other doses, other amylin analogues, other GLP-1 receptor agonists, or products combined outside a trial.
• Larger weight loss and lower blood pressure in a trial are measured outcomes of a studied product. They are not a recommendation to combine these substances, and this reference gives no combination or regimen guidance.