Orforglipron hemicalcium for Chronic kidney disease | Atherosclerotic cardiovascular disease

Inclusion criteria

• {"criterion_text":"- Have heart disease, kidney disease, or both"}

Exclusion criteria

• {"criterion_text":"- Have type 1 diabetes"}
• {"criterion_text":"- Have had a serious heart condition within 60 days of screening"}
• {"criterion_text":"- Have New York Heart Association Functional Classification Class IV heart failure"}

Primary endpoints

• {"endpoint_text":"- Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death [Time Frame: Baseline up to end of study (about 5 years)]","definition_or_measurement_approach":"Composite endpoint including nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death; Time Frame: Baseline up to end of study (about 5 years)"}

Methods

• Trialbee digital marketing content (documented as 'K2_Recruitment Material_Trialbee_Digital marketing content')
• Trialbee landing page ('K2_Recruitment Material_Trialbee_Landing page')
• Printed materials: Flyer, Poster, Brochure (documents titled 'Flyer Master', 'Poster Master', 'Brochure Master')
• Letters from doctor to patient ('Letter Doctor to Patient' / 'Letter Doctor Referral')
• Patient community outreach (Trialbee patient community outreach documents)
• ZoomHealth / Study Connect related materials (documents: ZoomHealth screenshots, Terms of Service, Privacy Statement)
• Country-specific recruitment packs and language variants (multiple K1/K2 country-associated recruitment documents listed)

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaceutical Product Development LLC

Responsibilities

Sponsor duties code: 4; listed contact kathy.dick@thermofisher.com

Name

PPD Global Central Labs / PPD Global Central Labs (S) Pte Ltd

Responsibilities

Central lab services indicated (sponsor duties code: 4); contact kathy.dick@thermofisher.com

Name

Iqvia Biotech LLC

Responsibilities

Duties code: 1 (operational role); contact els.vannylen@iqvia.com

Third parties

• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Sponsor duties code: 4; contact kathy.dick@thermofisher.com","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"Patient Screening, Recruitment and Retention; contact bill.abbott@trialbee.com","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Duties codes: 1, 12, 15 (includes negotiation/execution of clinical trial agreements and payments); contact clinops@lilly.gr","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient Screening, Recruitment and Retention; contact george.dorsett@clariness.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"China","full_name":"Pharmaceutical Product Development, LLC (Shanghai address)","duties_or_roles":"Sponsor duties code: 4; contact kathy.dick@thermofisher.com","organisation_type":"Health care"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Sponsor duties code: 4; contact kathy.dick@thermofisher.com","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"Sponsor duties code: 4; contact kathy.dick@thermofisher.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Sponsor duties code: 1; contact els.vannylen@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Sponsor duties code: 6; contact pavel.burmenko@veeva.com","organisation_type":"Non-Pharmaceutical company"}