H. Brandt-Jacobsen, Niels
Johansen, Marie Louise
Rasmussen, Jon J.
Dalsgaard, Morten
Kumler, Thomas
Faber, Jens
Rossignol, Patrick
Schou, Morten
Kistorp, Caroline
Article History
Received: 18 February 2022
Accepted: 14 March 2023
First Online: 31 March 2023
Declarations
:
: The study protocol was approved by the Regional Scientific Ethics Committee (H-15009313), the Danish Data Protection Agency (2012–58-0004), participants supplied written and verbal informed consent, and the study was completed in accordance with the Declaration of Helsinki. The trial was conducted and monitored by an independent unit from Copenhagen, Denmark, in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice. The trial was registered at the European Clinical Trials Register (Date of registration: 25/08/2015, EudraCT number: 2015–002519-14). Due to an inability of performing NMR-imaging on the required patients needed to adhere to the initial power calculation of the primary endpoint, liver fat, an amendment was added to the protocol allowing the inclusion of an additional 10 patients. The amendment was not influenced by conditions concerning the reported endpoints in the present manuscript.
: Not applicable.
: C.K. has served on scientific advisory panels and/or received speaker fees from Boehringer Ingelheim, Merck Shape and Dome, Astra Zeneca, Amgen, Novartis, Novo Nordisk and Shire. P.R. reports personal fees from Ablative Solutions, AstraZeneca, Bayer, Boehringer-Ingelheim, Corvidia, CVRx, Fresenius, G3P (stocks), Grunenthal, Idorsia, KBP, Novartis, NovoNordisk, Relypsa, Sanofi, Sequana Medical, Servier, Stealth Peptides, Vifor, Vifor Fresenius Medical Care Renal Pharma; and Cofounder: CardioRenal, outside the submitted work. T.K has served on scientific advisory panels and/or received speaker fees from Boehringer Ingelheim, Merck Shape and Dome, Astra Zeneca, Bristol Meyer Squibb, Bayer, and J.F. has served on scientific advisory boards at Merck Shape and Dome, Astra Zeneca, Novo Nordisk and Otsuka. N.B.J, M.L.J., J.R., M.D., and M.S. have nothing to declare.