LY3437943 SODIUM for Obesity|Overweight|Atherosclerotic cardiovascular disease|Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Must be 45 years old or older"}
• {"criterion_text":"- Have BMI of >27.0 kg/m2"}
• {"criterion_text":"- Have established ASCVD and/or CKD"}
• {"criterion_text":"- With or without T2D as long as HbA1c<10%"}

Exclusion criteria

• {"criterion_text":"- Have Type 1 Diabetes"}
• {"criterion_text":"- Have had or plan to have a surgical treatment for obesity"}
• {"criterion_text":"- Have an eGFR <20 mL/min/1.73 m2 at screening"}
• {"criterion_text":"- Have any of the following cardiovascular conditions ≤ 90 days prior to randomization: Myocardial infarction, Acute coronary syndrome, Stroke, or coronary, peripheral, or carotid artery arterial revascularization procedure"}
• {"criterion_text":"- Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2"}
• {"criterion_text":"- Have acute decompensated heart failure requiring hospitalization"}
• {"criterion_text":"- Have New York Heart Association (NYHA) Classification Class IV heart failure at screening"}

Primary endpoints

• {"endpoint_text":"- Time to First Occurrence of Composite Endpoints A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF)","definition_or_measurement_approach":"Time-to-event analysis: time from randomization to first occurrence of the composite of nonfatal MI, nonfatal stroke, CV death, or hospitalization/urgent visit due to heart failure."}
• {"endpoint_text":"- Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death","definition_or_measurement_approach":"Time-to-event analysis: time from randomization to first occurrence of the composite of ESKD, sustained ≥40% decline in eGFR, cardiovascular death, or renal death."}

Methods

• Site-based recruitment via participating hospitals and clinics (local investigators and referral from clinicians).
• Printed recruitment materials: flyers, posters, trial brochures (country-specific versions) for distribution at sites and clinical settings.
• Doctor referral letters (materials for healthcare professionals to refer eligible patients).
• Patient-facing outreach via patient organisations/associations (identified as participating organisations/sites in some countries).
• Digital and remote recruitment: Trialbee patient community outreach, Trialbee landing pages, and digital marketing content (online ads/landing pages) as documented in recruitment materials.
• Study-specific participant information and welcome letters, visit cards and patient information cards distributed at sites.

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Adjudication

Name

IQVIA Rds Inc.

Responsibilities

Site readiness and associated services; site-related operational support

Name

CRS Clinical Research Services Management GmbH

Responsibilities

Clinical research services (listed among organisations involved in country-specific activities)

Third parties

• {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Negotiation & execution of clinical trial agreements with the Greek participating sites and study payments based on invoices.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Laboratory services (sponsor duties code 4)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Data management / eClinical services (sponsor duties code 6)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Adjudication (sponsor duties code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Techdata Service Company LLC","duties_or_roles":"Technical services (sponsor duties code 10)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Indiana University","duties_or_roles":"Site-related services (sponsor duties code 10)","organisation_type":"Health care"}
• {"country":"United States","full_name":"Brightech International, LLC","duties_or_roles":"Site-related services (sponsor duties code 10)","organisation_type":"Health care"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Data services (sponsor duties code 6)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"R&G US Inc.","duties_or_roles":"Site-related services (sponsor duties code 10)","organisation_type":"Health care"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Laboratory services (duplicate entry in third party list)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"IQVIA Rds Inc.","duties_or_roles":"Site readiness and related services (sponsor duties code 1; sponsor duties code 15 'Site Readiness' indicated)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central lab services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"CRU Hungary Kft.","duties_or_roles":"Adjudication (sponsor duties code 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}