This Study Collects Information on the Safety of Inhaled Pegylated Adrenomedullin (PEG-ADM), How the Drug is Tolerated and How it Affects Patients Suffering From a Type of Lung Failure That Cause Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)

Summary

The study is composed of two parts. In part A of the study two active doses of inhaled pegylated adrenomedullin (PEG-ADM) will be compared regarding safety and efficacy to a substance that has no therapeutic effect (placebo) in order to find an optimal and safe of the study drug. In part B of the study the highest dose that is considered safe and has demonstrated efficacy will be taken forward to collect information how well patients suffering from Acute Respiratory Distress Syndrome (ARDS) respond to treatment with inhaled pegylated adrenomedullin (PEG-ADM) compared to treatment with placebo. ARDS is a type of lung failure that cause fluid to build up in the lungs making breathing difficult or impossible.

Timeline

Start

2020-07-07

Primary completion

2022-12-28

Completion

2022-12-28

Outcome

Missed primary endpoint

Stopped: “Terminated (based on Part A results, Bayer decided to not continue investigating BAY 1097761 further in Part B; this was not due to any safety data for BAY 1097761)”

paper However, no significant efficacy was observed on the clinical utility index. PMID 41131549 ↗

paper Inhaled PEG-ADM was well tolerated in patients with acute respiratory distress syndrome, but it did not improve clinical outcomes PMID 41131549 ↗

Publications

• Karagiannidis C, McAuley DF, Thompson BT, Reimer T, Shakery K, Schmitz S, Cortes MN, Ullrich R, Meziani F, Mercat A, Chiumello D, Duska F, Combes A; SEAL Trial Investigators. Safety and efficacy of inhaled PEG-ADM in ARDS patients: a randomised controlled trial. Crit Care. 2025 Oct 23;29(1):448. doi: 10.1186/s13054-025-05617-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BAY1097761	Unknown	960 ug	Inhaled
Subject	BAY1097761	Unknown	1920 ug	Inhaled

Indications