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Article History

Received: 25 March 2026

Accepted: 12 June 2026

First Online: 9 July 2026

Declarations

:

: The GDFather-001 trial was approved by the national competent authorities (Paul-Ehrlich-Institut for Germany; Agencia Espanola de Medicamentos y Productos Sanitarios for Spain, and Swissmedic for Switzerland) of the participating countries and by the institutional review boards (i.e., by the ethics committees) at each participating site. All participants provided written informed consent.

: J.H. is a co-founder of the biotech company CatalYm GmbH, owner of GDF-15 related patents and stock owner of Catalym GmbH. C.S.W., J.A., F.L., A.A., M.F., K.K., P.F., M.L., A.A., S.S., F.H. and E.L. are current or former employees of CatalYm GmbH and/or hold stock options of Catalym GmbH. J.W., I.M. and H.H. have received research funding or consulting and/or advisory fees from Catalym GmbH. Several coauthors declare potentially competing interests (grants or contracts and/or royalties or licenses, stock or stock options, consulting fees, honoraria, travel or meeting support, or advisory or data safety monitoring board participation) apart from their relationship with CatalYm GmbH: I.M. (research grants from Roche, Bristol-Myers Squibb, Genmab and AstraZeneca; honoraria from Genmab, Mestag, Flagship, Bright Peak, Curon, Pharmamar, AstraZeneca, Bioinvent, Warewolf, Qbiotics, AstraZeneca and Johnson & Johnson); E.G.C. (grants from Novartis, Roche, ThermoFisher, AstraZeneca, Taiho, BeiGene, Janssen, Anaveon; honoraria from Roche, Ellipses Pharma, Boehringer Ingelheim, Janssen Global Services, Seattle Genetics, SeaGen, Skypta, Sotio, Sanofi, Anaveon, Abbvie, Astex Therapeutics, Alentis Therapeutics, Marengo Therapeutics, Incyte, Lilly, Medpace, Pfizer, Amgen, GenMab, Genentech, GreyWolf, Gilead, Daiichi Sankyo, Takeda Pharmaceuticals, Pyramid Biosciences; stock options from 1TrialSP); G.d.V. (Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Ipsen, Janssen Merck Sharp & Dohme, Merck Serono, Pfizer and Roche); M.J. (grants from AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi-Sankyo, Immunophotonics, Innomedica, Lilly, Merck Sharp & Dohme, Novartis, Intensity Therapeutics, Roche, Sanofi, Takeda, Incyte, Debiopharm, Anaveon; honoraria from AstraZeneca, Bayer, Bristol-Myers Squibb, Johnson & Johnson, Merck Sharp & Dohme, Roche, Sanofi); J.M.L. (grants and research contracts from Astellas, BMS, Highlight Therapeutics, Ipsen, Merck Serono, Merck Sharp & Dohme, Novartis, Roche, Pfizer, PharmaMar, Pierre Fabre, Regeneron, Sanofi and Trialing Health); M.R. (institutional research grants from Bayer and Ipsen; consultancy/advisory roles for AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly, Geneos, Ipsen, Merck, Roche, Universal DX, Boston Scientific, Engitix Therapeutics, Parabilis Medicines Inc, Boehringer Ingelheim); D.K. (grant from Geistlich-Stucki-Stiftung; honoraria/fees from Amgen, AstraZeneca, Amgen, Bristol-Myers Squibb, Iaculis, Johnson & Johnson, Merck Serono, Merck Sharp & Dohme, Mirati, Novartis, PharmaMar, Roche and Sanofi); J.T. (AstraZeneca, Bristol Myers Squibb, Institut fur Qualitatssicherung und Transparenz im Gesundheitswesen, Merck Serono, Merck Sharp & Dome, Oncolytics Biotech, onkowissen.de, Roche); M.S. (grants from Bristol-Myers Squibb and Johnson & Johnson; honoraria/consultancy from/for Amgen, AstraZeneca, Bristol Myers Squibb, Gilead, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck Sharp & Dohme, Novartis, Regeneron, Roche, Sanofi); R.D. (consultancy/advisory roles for Novartis, Merck Sharp & Dohme, Bristol-Myers Squibb, Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, T3 Pharma, MaxiVAX SA, Pfizer, Simcere and Iovance, Oncobit. Derma2go); M.R.R. (AstraZeneca, Bristol-Myers Squibb, Roche); R.Y. (honoraria/fees from Merck, Boehringer Ingelheim, Kura Oncology, BioNTech); G.P. (Roche and Pierre Fabre); J.E.V. (research funding and honoraria from Astellas Pharma); M.S.Z. (AstraZeneca, BTG, Captor, Bayer, Eisai-MSD, Roche); C.K. (honoraria/fees from Ipsen, Astra Zeneca, StreamedUp, NeoConnect, Merck, Sharp & Dohme, Servier, Bristol-Myers Squibb, Incyte, Takeda, Amgen, BeiGene, Roche, Jazz Pharma, GI-OnkoNET Rhein Main, DGVS, Leo Pharma); C.S. (Bristol-Myers Squibb, Boehringer Ingelheim, Ipsen); E.R. (BMS, Eli Lilly, Kyowa Kirin, Leo Pharma, Merck Sharp & Dohme, Pierre Fabre and Sanofi); P.G. (Bayer, AstraZeneca, Merck Sharp & Dohme, Bristol-Myers Squibb, Roche); A.N. (AstraZeneca, Merck Sharp & Dohme, Incyte, Bristol-Myers Squibb, Gilead Science, Seattle Genetics, Astellas, Geneta Science, Janssen, PeerView, PeerVoice, Merck Serono, Samsung Bioepis, Bicycle Therapeutics); M.R. (honoraria/fees from Accord, Amgen, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Merck Serono, Merck Sharp & Dohme, Mirati, Novartis, Pfizer, Regeneron, Roche, Sanofi, Daiichi-Sankyo, Janssen); M.F. (Stock options from Thermo Fisher Scientific); P.F. (Stock options from Amgen and BionTech); C.S.W. (Stock options from Merck Sharp & Dohme and RNhale). M.d.M., M.E.G., G.A., K.L.K., P.S.V., H.L., T.G., Z.T., H.H., F.G., J.B. and T.S. disclosed no other relationships or conflicts of interest.