BI 690517 for Type 2 diabetes | Hypertension | Cardiovascular disease

Inclusion criteria

• {"criterion_text":"- At least 18 years old at time of consent"}
• {"criterion_text":"- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial"}
• {"criterion_text":"- Male or female participants. WOCBP (see Section 4.2.2.3) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly."}
• {"criterion_text":"- Participants with medical history of hypertension and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)"}
• {"criterion_text":"- Participants with medical history of T2DM and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)"}
• {"criterion_text":"- Established CV disease and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)."}
• {"criterion_text":"- At least one additional risk factor for developing HF"}

Exclusion criteria

• {"criterion_text":"- History of HF or hospitalization for HF or treatment of HF"}
• {"criterion_text":"- Atrial fibrillation or Atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1 (screening)"}
• {"criterion_text":"- Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)"}
• {"criterion_text":"- Treatment with an MRA"}
• {"criterion_text":"- Treatment with amiloride or other potassium-sparing diuretic"}
• {"criterion_text":"- Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial: o A direct renin inhibitor (e.g. aliskiren) o More than one ACEi and/or ARB (including ARNi) used simultaneously o Other aldosterone synthase inhibitors (e.g. baxdrostat) o Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)"}
• {"criterion_text":"- Further exclusion criteria apply."}

Primary endpoints

• {"endpoint_text":"- Time to first event of CV death or HFE (defined as HHF or urgent HF visit)","definition_or_measurement_approach":"Time-to-event measure: time from randomisation to first occurrence of cardiovascular (CV) death or heart failure event (HFE). HFE is defined as hospitalisation for heart failure (HHF) or an urgent heart failure visit."}

Secondary endpoints

• {"endpoint_text":"- Time to first event of CV death or HHF","definition_or_measurement_approach":"Time from randomisation to first CV death or first hospitalisation for heart failure (HHF)."}
• {"endpoint_text":"- Absolute change from baseline in mean SBP [mmHg] at Week 24","definition_or_measurement_approach":"Absolute change from baseline to Week 24 in mean systolic blood pressure (SBP), measured in mmHg."}
• {"endpoint_text":"- Relative change from baseline in UACR [mg/g] at Week 24","definition_or_measurement_approach":"Relative change from baseline to Week 24 in urine albumin-to-creatinine ratio (UACR) measured in mg/g."}
• {"endpoint_text":"- Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death","definition_or_measurement_approach":"Time-to-event for the composite of kidney disease progression, hospitalisation for heart failure (HHF), or cardiovascular death."}
• {"endpoint_text":"- Time to first event of CV death, HFE, non-fatal MI or non-fatal stroke (4-point MACE)","definition_or_measurement_approach":"Time from randomisation to first occurrence of CV death, heart failure event (HFE), non-fatal myocardial infarction (MI), or non-fatal stroke (4‑point major adverse cardiovascular events, MACE)."}
• {"endpoint_text":"- Occurrences of all-cause hospitalisations (first and recurrent)","definition_or_measurement_approach":"Count and timing of hospitalisations for any cause, including first and recurrent events."}
• {"endpoint_text":"- Time to first event of new-onset atrial fibrillation or atrial flutter (in participants without history of atrial fibrillation and atrial flutter) or CV death","definition_or_measurement_approach":"Time from randomisation to first new-onset atrial fibrillation or atrial flutter (in participants without history) or cardiovascular death."}
• {"endpoint_text":"- Time to all-cause death","definition_or_measurement_approach":"Time from randomisation to death from any cause."}
• {"endpoint_text":"- Time to CV death","definition_or_measurement_approach":"Time from randomisation to death due to cardiovascular causes."}
• {"endpoint_text":"- Time to first HHF","definition_or_measurement_approach":"Time from randomisation to first hospitalisation for heart failure (HHF)."}
• {"endpoint_text":"- Time to first event of new-onset HF or CV death","definition_or_measurement_approach":"Time from randomisation to first occurrence of new-onset heart failure (HF) or cardiovascular death."}
• {"endpoint_text":"- Occurrences of HHF (first and recurrent)","definition_or_measurement_approach":"Count and timing of hospitalisations for heart failure, including first and recurrent HHF events."}
• {"endpoint_text":"- Absolute change from baseline in mean DBP [mmHg] at Week 24","definition_or_measurement_approach":"Absolute change from baseline to Week 24 in mean diastolic blood pressure (DBP), measured in mmHg."}

Methods

• Study flyers and patient brochures (clinic/hospital distribution) — country-specific translated brochures and flyers are provided (many country-specific brochure/flyer documents listed).
• Clinical wall posters displayed at participating sites (clinic posters) — site-level posters available per country.
• Database letters / direct contact letters to potential participants (database-letter documents listed for multiple countries).
• Video scripts / informational videos for recruitment and education (video scripts provided in multiple languages).
• Pre-screening website and online pre-screening content (pre-screening web content / website text documents listed).
• Social media and online advertising campaigns (social media/ad content and recruitment slogans documented for some countries).
• GP/clinic outreach letters and invitations (GP or clinic letters / participant journey emails listed).
• SMS/Signal messaging for outreach in some locales (signal/SMS noted in recruitment materials list).

Primary sponsor

Full Name

Boehringer Ingelheim International GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

IQVIA RDS Hellas Single Member S.A.

Responsibilities

Start-up & Contract negotiation; site start-up activities (sponsor duties codes include 1,12,15)

Name

IQVIA Limited

Responsibilities

Study start-up & contract negotiation; site initiation and start-up (sponsor duties codes include 1,12,15)

Third parties

• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Start-up & Contract negotiation; other sponsor duties (codes 1,12,15 listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Study start-up & contract negotiation; other sponsor duties (codes 1,12,15 listed)","organisation_type":"Pharmaceutical company"}

Co-sponsors

• Boehringer Ingelheim Espana S.A.