Evidence map›Paper›PMID 42362866›Full record

ArticleNature medicine2026

Cliramitug for depletion of cardiac amyloid transthyretin: long-term follow-up of the NI006-101 trial.

Peter C Kahr, Fabian Aus dem Siepen, Olivier Lairez, Erwan Donal, Thibaud Damy, Arnt V Kristen, Cristina C Quarta, Michele F Mercuri, Sarah Keppner-Witter, Eva Herrmann-Keiner and 7 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

17 authors.

Peter C KahrNeurimmune AG, Schlieren, Switzerland.
Fabian Aus dem SiepenDepartment of Cardiology, University Hospital Heidelberg, Heidelberg, Germany.
Olivier LairezUniversity of Toulouse, Toulouse University Hospital, HealthAge Institute, Department of Cardiology, Toulouse, France.
Erwan DonalDepartment of Cardiology, University of Rennes, CHU Rennes, INSERM, Rennes, France.
Thibaud DamyCardiology Department and French National Reference Centre for Cardiac Amyloidosis, at Hôpitaux Universitaires Henri Mondor, AP-HP, and IMRB, INSERM, Université Paris Est Creteil, and F-CRIN GRACE, Créteil, France.
Arnt V KristenCardiovascular Center Darmstadt, Darmstadt, Germany.
Cristina C QuartaAmyloidosis and Rare Cardiology, Clinical Development, Alexion, AstraZeneca Rare Disease, Boston, MA, USA.
Michele F MercuriAmyloidosis and Rare Cardiology, Clinical Development, Alexion, AstraZeneca Rare Disease, Boston, MA, USA.
Sarah Keppner-WitterNeurimmune AG, Schlieren, Switzerland.
Eva Herrmann-KeinerNeurimmune AG, Schlieren, Switzerland.
Mia TichyNeurimmune AG, Schlieren, Switzerland.
Aubin MichalonNeurimmune AG, Schlieren, Switzerland.ORCID http://orcid.org/0000-0002-5246-4881
Jan GrimmNeurimmune AG, Schlieren, Switzerland.ORCID http://orcid.org/0000-0002-3898-3298
Roger M NitschNeurimmune AG, Schlieren, Switzerland.
Christoph HockNeurimmune AG, Schlieren, Switzerland.
Pablo Garcia-PaviaHospital Universitario Puerta de Hierro Majadahonda, IDIPHISA, CIBERCV, Madrid, Spain.
Peter van der MeerDepartment of Cardiology, University Medical Center Groningen, Groningen, The Netherlands. p.van.der.meer@umcg.nl.ORCID http://orcid.org/0000-0002-9705-4413

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a first-in-human trial (NI006-101), the monoclonal antibody cliramitug, targeting misfolded transthyretin, demonstrated a favorable safety profile and time- and dose-dependent reductions in surrogate markers of cardiac amyloid burden over the course of 12 months in patients with amyloid transthyretin cardiomyopathy (ATTR-CM). Here we evaluate the long-term safety and efficacy of cliramitug in a subgroup of participants of the NI006-101 trial who continued treatment in a second open-label extension (OLE2) and further explore dose- and time-dependent effects on amyloid depletion, cardiac biomarkers and cardiac structure and function. Twenty-three participants (20 receiving background treatment with tafamidis, all male) entered OLE2 and received a median of 10 additional infusions, increasing the maximum total exposure to 24 infusions and extending the median follow-up to 29.3 months. Thirteen participants initially treated with ≤10 mg kg

Indexed as

Amyloid Neuropathies, FamilialAntibodies, MonoclonalCardiomyopathiesPrealbuminAgedAmyloidBenzoxazolesBiomarkersFemaleFollow-Up StudiesHumansMaleMiddle AgedAmyloidAntibodies, MonoclonalBenzoxazolesBiomarkersPrealbumintafamidis

Identifiers

PMID42362866
PMCPMC13375531

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Registered trials

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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 OpenQuestion graph.