LY3437943 SODIUM for Metabolic Dysfunction-Associated Steatotic Liver Disease

Inclusion criteria

• {"criterion_text":"- Have hepatic steatosis (liver fat), diagnosed with MRI"}
• {"criterion_text":"- Have liver fibrosis, diagnosed with non-invasive tests"}
• {"criterion_text":"- (Liver biopsy not needed for enrollment in this trial)"}

Exclusion criteria

• {"criterion_text":"- Have any other type of liver disease other than MASLD"}
• {"criterion_text":"- Have a body mass index (BMI) <25 kilogram per square meter (kg/m2)"}
• {"criterion_text":"- Prior cirrhotic liver disease (history of esophageal / gastric varices, ascites, hepatic encephalopathy, historical diagnosis of cirrhosis on liver biopsy)"}
• {"criterion_text":"- Have lost more than 11 pounds within the 3 months prior to screening"}
• {"criterion_text":"- Have a hemoglobin A1c (HbA1c) greater than 10%"}
• {"criterion_text":"- Have type 1 diabetes"}

Primary endpoints

• {"endpoint_text":"- Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)","definition_or_measurement_approach":"Time-to-event (time from baseline to first occurrence of any component of the composite MALO endpoint)."}
• {"endpoint_text":"- Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality","definition_or_measurement_approach":"Composite clinical endpoint defined by the listed hepatic outcomes; occurrence of any listed component counts toward the composite. Clinical assessments and diagnostic tests as per protocol to identify components (e.g. imaging/clinical diagnosis, MELD score changes, documentation of transplantation or death)."}
• {"endpoint_text":"- [Time Frame: Baseline up to Study Completion (about 224 weeks)]","definition_or_measurement_approach":"Follow-up/time frame for primary endpoints is from baseline to study completion, approximately 224 weeks (~1568 days)."}

Methods

• Flyers (K2_Recruitment material_Flyer_* files) — site and country-specific patient-facing flyers for outreach
• Posters (K2_Recruitment material_Poster_* files) — site posters for clinic/hospital recruitment
• Brochures (K2_Recruitment material_Brochure_* files) — informational brochures for potential participants
• Letter Doctor-to-Patient / Doctor Referral letters (K2_Recruitment material_Letter-Doctor-to-Patient_*, K2_Recruitment material_Letter-Doctor-Referral) — clinician-mediated recruitment
• Patient-facing landing page / website text (L2_Other subject information material_Patient-facing landing page, K2_Recruitment material_PRC Website Text) — online information for prospective participants
• ClinLife materials / EC notes (K2_Recruitment material_ClinLife_EC-Notes) — digital recruitment/engagement materials referenced
• Patient invitation email (L2_Subject information material_N1T-MC-MALO_eConsent Submission Letter, L2_Other subject information material_Study Connect/Participant Invitation email) — direct electronic invitations
• ZoomHealth / IQVIA eConsent and remote platforms (K3_Retention material_ZoomHealth Terms of Service, L2_Other subject information material_IQVIA eConsent Privacy Policy, ZoomHealth files) — remote eConsent and remote recruitment/retention support
• Site referral and specialist clinic recruitment (K1_List of participating sites, K1_Recruitment arrangements documents) — recruitment via participating hepatology/gastroenterology/endocrinology clinics

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research LLC / Icon Clinical Research Limited

Responsibilities

Clinical research services (listed duties include code 4 and 13 in sponsorDuties entries)

Name

IQVIA Limited

Responsibilities

Site selection and other vendor services (sponsor duties include codes 1 and 15/site selection)

Third parties

• {"country":"United States","full_name":"CRIO Inc","duties_or_roles":"7","organisation_type":"Health care"}
• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"4","organisation_type":"Health care"}
• {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG (Investigator Space)","duties_or_roles":"15","organisation_type":"Health care"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Echosens","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"15","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"15 (Linguistically Validated Translations)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited (additional entry)","duties_or_roles":"15 (Site Selection)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited (additional entry)","duties_or_roles":"13","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"15 (DMC Support)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pathai Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc. (additional entry)","duties_or_roles":"15","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC (duplicate entry)","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}