Randomised study for double-blind, placebo-controlled evaluation of BI 765845 on top of standard of care in patients with myocardial infarction

The primary objective of this study is to evaluate the **efficacy** of BI 765845 compared with placebo in patients with acute myocardial infarction. This assessment is crucial for determining the therapeutic potential of BI 765845 in improving clinical outcomes in this patient population. Additionally, the study aims to assess the safety and tolerability of BI 765845, as well as to characterize the dose-response relationship to identify the optimal dose for future Phase III trials.

Secondary objectives include:

• Analyzing myocardial infarct size (IS) using cardiac magnetic resonance (CMR) imaging at Day 5 and Day 90.
• Assessing clinical efficacy at Day 90 by evaluating several specific clinical parameters.
• Evaluating safety until Day 90 by monitoring the occurrence of serious adverse events (SAEs) and drug-related adverse events.

The clinical trial involves a total of **147 participants** diagnosed with **acute myocardial infarction**. The study population includes both male and female subjects, aged 18 years and older, who are of non-childbearing potential. Participants were selected based on the onset of symptoms of myocardial ischemia or infarction occurring between 1 to 12 hours prior to randomization. The trial does not include a vulnerable population. Participants are required to have signed informed consent in accordance with ICH Good Clinical Practice and local legislation. The study does not specify any particular lifestyle considerations such as diet or physical activity. Key inclusion criteria include the legal age of consent and the ability to use effective birth control methods for male participants. Further criteria apply, but these are not detailed in the provided data.

The clinical trial is designed as a **randomized**, **double-blind**, **placebo-controlled** study to evaluate the efficacy and safety of **BI 765845** in patients with **acute myocardial infarction**. The trial aims to assess the dose-response relationship and identify the optimal dose for future studies. The study will involve the administration of BI 765845, a solution for injection/infusion, and a matching placebo, both delivered intravenously. The trial is expected to commence recruitment on October 9, 2023, and conclude by March 1, 2027.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, informed consent, and recent onset of myocardial ischemia symptoms. Following randomization, participants will receive either BI 765845 or placebo. The study will include multiple follow-up visits to monitor the primary endpoint of infarct severity and assess secondary safety and tolerability outcomes. The end-of-study visit will conclude the participant's involvement, which is anticipated to last for the duration of the treatment period, not exceeding one year.

Participants may be withdrawn from the study early if they experience adverse events, fail to adhere to the protocol, or withdraw consent. The trial will adhere to ICH Good Clinical Practice guidelines and local regulations to ensure the safety and well-being of all participants. The study's findings will contribute to the understanding of BI 765845's therapeutic potential in managing acute myocardial infarction.

The clinical trial involves the administration of **BI 765845**, an investigational medication, which is a **solution for injection/infusion**. The active substance, also named BI 765845, is of biological origin, specifically a protein. The medication is administered **intravenously** with a maximum daily dose of 1200 mg. The total dose should not exceed 1200 mg over the treatment period, which is limited to one day. The investigational product is developed by Boehringer Ingelheim International and is identified by the sponsor product code BI 765845.

A **placebo** matching BI 765845 is used as a comparator in this double-blind, placebo-controlled study. The placebo is designed to mimic the investigational product in appearance and administration route, which is also **intravenous**. The placebo does not contain any active substance and serves to evaluate the efficacy and safety of BI 765845 by providing a baseline for comparison.

Additionally, **Gadovist 1.0 mmol/ml solution for injection** is utilized as an auxiliary treatment. This product contains the active substance **gadobutrol**, a chemical compound, and is administered **intravenously**. The maximum daily dose is 0.1 milliliters per kilogram, with a total dose not exceeding 1.5 mmol/kg. Gadovist is manufactured by Bayer PLC and is used to enhance imaging in the context of the trial, providing essential diagnostic support.

The efficacy of BI 765845 in patients with **myocardial infarction** will be assessed in a randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the severity of the infarct. This parameter will be measured and analyzed to determine the impact of BI 765845 compared to placebo. The trial aims to characterize the dose-response relationship and identify the optimal dose of BI 765845 for future studies. The assessment will be conducted in accordance with the trial's main objective, which includes evaluating the efficacy, safety, and tolerability of BI 765845. The trial is designed to provide comprehensive data on the therapeutic potential of BI 765845 in the context of standard care for myocardial infarction.