Evidence mapPaperPMID 42228334Full record

Trial reportClinical pharmacokinetics2026

Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.

Mette J F Nielsen, Niels-Peter Becker, Helene H Hansen Duus, Katrine Kirkeby, Viera Kupčová, Britt W Lauenborg, Benjamin Low, Olivia Svolgaard, Louise Witten

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04209049 phase1completednot on this map

An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NNC0174-0833 in Subjects With Normal Renal Function and Impaired Renal Function

TypeinterventionalSponsorNovo Nordisk A/SRan2020 to 2021Enrolled33ConditionsOverweight, ObesityArmsNNC0174-0833
NCT05564104 phase1completednot on this map

A Study Investigating the Pharmacokinetic Properties of Cagrilintide in Participants With Various Degrees of Hepatic Impairment and Assessing the Absolute Bioavailability of Subcutaneous Cagrilintide in Healthy Volunteers

TypeinterventionalSponsorNovo Nordisk A/SRan2023 to 2024Enrolled32ConditionsHepatic Impairment, Healthy VolunteersArmsCagrilintide
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Mette J F NielsenNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark. MJXF@novonordisk.com.
Niels-Peter BeckerNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Helene H Hansen DuusNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Katrine KirkebyNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Viera KupčováMedical Faculty, Dérer's Hospital, Bratislava, Slovakia.
Britt W LauenborgNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Benjamin LowNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Olivia SvolgaardNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Louise WittenNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesCagrilintide is a long-acting amylin agonist under development as monotherapy for weight management and as a fixed-dose combination with the glucagon-like peptide-1 receptor agonist semaglutide (CagriSema) for weight management and treatment of type 2 diabetes. Two studies were conducted to assess the effects of renal or hepatic impairment on pharmacokinetics, safety and tolerability following single doses of cagrilintide.

methodsIn both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively. The primary endpoint was area under the cagrilintide plasma concentration curve from time zero extrapolated to infinity (AUC

resultsThe renal impairment study included 33 participants (normal function, n = 14; mild impairment, n = 7; moderate impairment, n = 7; severe impairment, n = 5) and the hepatic impairment study included 32 participants (normal function, n = 14; mild impairment, n = 7; moderate impairment, n = 7; severe impairment, n = 4). In both studies, total cagrilintide exposure (AUC

conclusionsIn these studies, within the limitations of small sample sizes, no clinically relevant differences in cagrilintide pharmacokinetics were observed in participants with renal or hepatic impairment compared with those with normal function, suggesting that dose adjustment is not warranted for these populations. Cagrilintide was well-tolerated and there were no unexpected safety issues.

trial registrationStudies are registered at ClinicalTrials.gov (NCT04209049 registered 23 December 2019 and NCT05564104 registered 3 October 2022).

Indexed as

Glucagon-Like PeptidesHypoglycemic AgentsLiver DiseasesRenal InsufficiencyAdultAgedArea Under CurveFemaleHumansInjections, SubcutaneousMaleMiddle AgedSemaglutideGlucagon-Like PeptidesHypoglycemic AgentsSemaglutide

Identifiers

PMID42228334
PMCPMC13356073

What Socratic holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.