CAGRILINTIDE, SEMAGLUTIDE for Cardiovascular disease|Type 2 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Male or female\n- Age above or equal to 55 years at the time of signing informed consent\n- Body mass index (BMI) ≥ 25.0 kg/m2\n- Established CVD as evidenced by at least one of the following: •\tPrior myocardial infarction •\tPrior stroke (ischemic or haemorrhagic stroke) •\tSymptomatic peripheral arterial disease (PAD) defined as at least one of the following: a.\tIntermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest b.\tIntermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound c.\tPrior revascularization procedure of a lower extremity peripheral artery d.\tLower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)\n- For participants with T2D at screening, the following inclusion criteria also apply: Diagnosed with type 2 diabetes mellitus (T2D) ≥ 180 days before screening. HbA1c 6.5%-10% (48-86 mmol/mol) (both inclusive), as measured by central laboratory at screening. Treatment with either: a.\tLifestyle intervention alone b.\t1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), DPP4-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label c.\tBasal insulin alone or in combination with up to two marketed OADs (refer to b. above), all according to local label"}

Exclusion criteria

• {"criterion_text":"- Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening\n- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n- Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening\n- Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening\n- End stage renal disease defined as eGFR < 15 mL/min/1.73 m2, as measured by the central laboratory at screening\n- Chronic or intermittent haemodialysis or peritoneal dialysis"}

Primary endpoints

• {"endpoint_text":"- Time to first occurrence of MACE, a composite endpoint consisting of: •\tCV death •\tnon-fatal myocardial infarction •\tnon-fatal stroke","definition_or_measurement_approach":"Time-to-event composite endpoint comprising cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (time to first occurrence)."}

Secondary endpoints

• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first occurrence of a composite endpoint consisting of: •\tOnset of persistent ≥40% reduction in eGFRcr (CKD EPI) compared with baseline •\tOnset of persistent eGFRcr (CKD-EPI) <15 mL/min/1.73 m2 •\tInitiation of chronic kidney replacement therapy (dialysis or kidney transplantation) •\tKidney death •\tCV death","definition_or_measurement_approach":"Time-to-event composite renal endpoint including persistent ≥40% reduction in eGFRcr (CKD-EPI), persistent eGFRcr <15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy, kidney death, or CV death."}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first occurrence of an expanded MACE composite endpoint consisting of: •\tCV death •\tnon-fatal myocardial infarction •\tnon-fatal stroke •\tcoronary revascularisation •\tunstable angina requiring hospitalisation","definition_or_measurement_approach":"Time-to-event composite endpoint (expanded MACE) comprising CV death, non-fatal MI, non-fatal stroke, coronary revascularisation, or unstable angina requiring hospitalisation."}
• {"endpoint_text":"- Time to first occurrence of a composite endpoint consisting of: •\tall-cause death •\tnon-fatal myocardial infarction •\tnon-fatal stroke","definition_or_measurement_approach":"Time-to-event composite endpoint comprising all-cause death, non-fatal MI, or non-fatal stroke."}
• {"endpoint_text":"- Time to first occurrence of myocardial infarction (fatal and non fatal)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first occurrence of stroke (fatal and non fatal)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Relative change in body weight","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in waist circumference","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in systolic blood pressure (SBP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in diastolic blood pressure (DBP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ratio to baseline in lipids: •\tTotal cholesterol •\tHDL cholesterol •\tLDL cholesterol •\tVLDL cholesterol •\tTriglycerides •\tFree fatty acids","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in HbA1c","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in SF-36v2: •\tPhysical Component Summary score •\tMental Component Summary score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of TESAEs","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of event adjudication committee (EAC)-confirmed malignant neoplasms","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of severe hypoglycaemic episodes (level 3) (only for participants with T2D at screening)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ratio to baseline in hsCRP","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ratio to baseline in TNF-α","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ratio to baseline in IL-6","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ratio to baseline in IL-1β","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in pain intensity rated by Numerical Rating Scale (NRS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in Pittsburgh Sleep Quality Index (PSQI)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in neuropathy status by baseline neuropathy group (painful neuropathy, painless neuropathy or no neuropathy)","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first occurrence of a composite endpoint consisting of: •\tOnset of persistent macro albuminuria •\tOnset of persistent ≥40% reduction in eGFRcr (CKD EPI) compared with baseline •\tOnset of persistent eGFRcr (CKD-EPI) <15 mL/min/1.73 m2 •\tInitiation of chronic kidney replacement therapy (dialysis or kidney transplantation) •\tKidney death","definition_or_measurement_approach":"Time-to-event composite renal endpoint including macroalbuminuria and other specified renal outcomes."}
• {"endpoint_text":"- Change in eGFRcr (CKD-EPI)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ratio to baseline in UACR","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in waist-to-height ratio","definition_or_measurement_approach":""}

Methods

• Country-specific recruitment arrangements documents and materials are provided (recruitment procedure and informed consent procedure documents per country).
• Use of recruitment materials including posters and advertisement texts (documents titled 'Recruitment materials', 'Recruitment Poster').
• Studyfinder / online study listing materials ('studyfinder information sheet').
• Direct-to-Patient approaches (documents and third-party role 'Direct to Patient').
• Email templates and advertisement links (e.g., Link2Trials) listed in country recruitment materials.

France

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

29-01-2026

Processing Time Days

547

Number Of Participants

80

Ireland

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

552

Number Of Participants

65

Netherlands

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

548

Number Of Participants

160

Poland

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

551

Number Of Participants

470

Denmark

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

29-01-2026

Processing Time Days

547

Number Of Participants

105

Bulgaria

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

552

Number Of Participants

400

Spain

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

552

Number Of Participants

160

Germany

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

548

Number Of Participants

300

Italy

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

551

Number Of Participants

271

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

IQVIA Limited

Responsibilities

Central Laboratory; contact Q2_eu_clinical_trials_information@iqvia.com

Name

Syneos Health IVH UK Limited / Syneos Health Inc.

Responsibilities

Clinical operations support (sponsor duties code 1)

Name

Icon Clinical Research Limited / Icon (Lr) Limited

Responsibilities

Services including ePRO translations, event adjudication, other sponsor duties

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central Laboratory; other sponsor duties (codes provided: 15, 4)","organisation_type":"Pharmaceutical company"}
• {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"Special Laboratory: Antibody analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Syneos Health IVH UK Limited","duties_or_roles":"Sponsor duty code 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Sponsor duty code 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"ePRO & eDiary translations","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special Laboratory: PK and biomarkers, Antibody analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF Supplier","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM and RTSM Help center","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to Patient","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"eCOA Supplier","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Excelya Germany GmbH","duties_or_roles":"Sponsor duty code 1","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duty code 1","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"ePRO & Cognitive debrief translations and Event Adjudication","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"eCOA Supplier","organisation_type":"Pharmaceutical company"}
• {"country":"","full_name":"Other third parties listed (various labs, translation and IT providers)","duties_or_roles":"","organisation_type":""}