Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- The participant and/or their parent/Legally Authorized Representative is willing and
able to provide signed informed consent or assent as appropriate
- Male or female adults 18 to 80 years of age, or adolescents 12 to 17 years of age
- Patients dependent on parenteral nutrition (PN) that receive PN for an average ≥ 4
days a week for 10 weeks or longer prior to screening to meet nutritional, caloric,
fluid, and/or electrolyte needs
- The Investigator expects no changes in the lipid, dextrose, amino acid, or vitamin
regimen to be medically necessary during the participant's participation in the study
- Willingness of participant to maintain his/her current habitual oral diet and fluids
regimen for the study duration
Exclusion Criteria:
- Participants taking steatogenic medications for ≥12 weeks in the past 12 months (e.g.,
amiodarone, tamoxifen, methotrexate, tetracycline, glucocorticoids, anabolic steroids,
over the usual dose of estrogen for hormone replacement therapy, and valproate); those
taking any medicine (e.g., metformin, thiazolidinediones, ursodeoxycholic acid,
pentoxifylline, S-adenosyl-L-Methionine, and betaine) that could affect the
measurement of IFALD within 12 weeks prior to study entry
- Participants taking potential hepatotoxic medications that in the judgement of the
Investigator is causing hepatic abnormalities
- Participants with a cardiac pacemaker, intravascular stents, other metallic devices,
and claustrophobia which are contraindicated to magnetic resonance imaging
- Participants who took choline supplements or choline-containing multivitamins within
14 days of screening
- History of major organ transplant (e.g., heart, kidney, liver, etc.)
For more information on eligibility criteria, please contact the sponsor.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.