Funding

The study was funded by AbbVie. AbbVie contributed to the study design, research, and interpretation of data, writing, reviewing, and approving the publication.

Conflict of interest

M.P., J.P., D.M.H., S.R.S., K.C.M., E.J.K., M.E.U., R.M.M., and A.R.P. are AbbVie employees and may hold AbbVie stocks or options. J.C.R. has no conflicts of interest to declare. T.M. is an employee and equity owner of Orlando Clinical Research Center. E.L. is a researcher for 89Bio Inc., AbbVie Inc., Akero Therapeutics, Alnylam Pharmaceuticals Inc., Amgen, Astrazeneca, Axcella Health, Boehringer Ingelheim, Bristol-Myers Squibb, Cymabay Therapeutics, DSM, Eli Lilly and Company, Enanta Pharmaceuticals, Enyo Pharma, Exalenz Bioscience, Galectin Therapeutics, Galmed Pharmaceuticals, Genfit, Genentech, Gilead Sciences, GlaxoSmithKline, Hanmi Pharmaceuticals, Hightide Biopharma, Intercept Pharmaceuticals, Inventiva, Janssen Pharmaceuticals, Madrigal Pharmaceuticals, Merck & Co., NGM Biopharmaceuticals Inc., Northsea Therapeutics, Novartis, Novo Nordisk Inc., Pfizer, Poxel Co., Roche, Sagimet Biosciences, Takeda, Terns Pharmaceuticals, Viking Therapeutics, and Zydus Pharmaceuticals; reports advisory board for Akero, Boehringer Ingelheim, BMS, Intercept, Novo Nordisk, Sagimet, and Terns; and speaker for AbbVie, Gilead Sciences, and Intercept.

Ethics approval

This study was conducted in compliance with the protocol, and in accordance with Good Clinical Practice guidelines and the ethical principles that have their origin in the Declaration of Helsinki. The protocol was approved by three institutional review boards: (a) Orlando Clinical Research Center, Orlando, FL (TESLA 222707 approved on 3 December 2020), (b) Clinical Pharmacology of Miami, Miami, FL (TESLA 222709 approved on 20 November 2020), and (c) Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX (TESLA 222740 approved on 20 September 2020).

Consent to participate

All participants provided written informed consent to participate in this study.

Consent for publication

Written informed consent for the publication of study reports or scientific presentations was obtained from the patients.

Data sharing statement

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the USA and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://vivli.org/ourmember/abbvie/, then select “Home.”

Code availability

Not applicable.

Author contributions

M.E.U., M.P., and A.R.P. wrote the manuscript. M.P., J.P., D.M.H., S.R.S., R.M.M., and A.R.P. designed the study. T.M., E.L., and J.C.R. collected the clinical data. M.E.U. and E.J.K. performed the data analysis. M.E.U., M.P., A.R.P., R.M.M., D.M.H., and S.R.S. interpreted the results. All authors participated in the critical review, revision of this manuscript, and provided approval of the manuscript for submission.