Urva, Shweta http://orcid.org/0000-0002-3681-479X
Quinlan, Tonya
Landry, John
Ma, Xiaosu
Martin, Jennifer A.
Benson, Charles T.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effects of Hepatic Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide
https://doi.org/10.1007/s40262-022-01140-3
Funding for this research was provided by:
Eli Lilly and Company
Article History
Accepted: 4 May 2022
First Online: 8 June 2022
Declarations
:
: Funding for this study was provided by Eli Lilly and Company.
: Shweta Urva, Tonya Quinlan, John Landry, Xiaosu Ma, Jennifer A. Martin, and Charles T. Benson are employees and shareholders of Eli Lilly and Company.
: The protocol was approved by local institutional review boards, and the trial was conducted in accordance with the principles of the Declaration of Helsinki and in accordance with the Good Clinical Practice guidelines of the International Council for Harmonisation.
: All participants gave their written informed consent to participate in this trial.
: Not applicable.
: Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at ExternalRef removed.
: Not applicable.
: SU, JL, JM, and CTB contributed to the study design. CTB provided medical oversight during the trial. JL was responsible for the statistical analyses. SU and CTB are the guarantors of this work and, as such, take responsibility for the integrity of the data and the accuracy of the data analysis. All authors participated in interpretation of the data and critical review of the manuscript, had full access to all the data in the study, and approved of this manuscript to be submitted for publication.