These are the nominees in the category Industry-Initiated Trial of the Year

The nomination process began in autumn 2025, and the jury received more than 100 nominations across the six categories: Centre of the Year, Researcher-Initiated Trial of the Year, Industry-Initiated Trial of the Year, Innovative Environment of the Year, Young Researcher of the Year, and Enthusiast of the Year.

Following a thorough review process, the jury selected a small number of nominees in each of the six categories.

The nominees for Industry-Initiated Trial of the Year are:
The REASON trial, Biogen
The HERMES trial, Novo Nordisk
The CORALreef Outcomes trial, MSD
The NyreSPOT trial, AstraZeneca
The Quintessential-2 trial, BMS
The REASON trial, Biogen

The REASON trial, Biogen

Biogen’s trial “A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults with Parkinson’s Disease” (the REASON trial) is a first-in-human Phase 1 trial investigating the potential use of a gene-therapy variant for the treatment of hereditary Parkinson’s disease. BIIB094 is an antisense oligonucleotide that can influence levels of leucine-rich repeat kinase 2, a protein for which genetic mutations are associated with development of the disease.

The trial was conducted in North America, the United Kingdom, Spain, Israel and Norway.

The principal investigator (PI) at Haukeland University Hospital, Charalampos Tzoulis, contributed not only through rapid recruitment of participants but also scientifically to this Phase 1 trial, both prior to initiation and during analysis and interpretation of the results. As a result, he has been granted co-authorship on the article currently under revision at Nature Medicine, the highest-ranked scientific journal globally within medicine.

It is rare for Norwegian PIs to be included as authors on publications from industry-initiated trials, particularly in Phase 1. This therefore helps increase the visibility of Norwegian research environments within neurodegenerative diseases. The attention generated will hopefully encourage more companies to recognise Norway as a country with strong research communities and expertise in conducting early-phase clinical trials.

The HERMES trial, Novo Nordisk

In Novo Nordisk’s HERMES trial, an entirely new hypothesis is being tested: that inflammation may be involved in the disease course of heart failure. The trial investigates whether ziltivekimab, a medicinal product that has demonstrated effects on inflammation in previous studies, can reduce the risk of major cardiovascular events in patients with heart failure. This is the first time such a hypothesis is being tested in a large endpoint trial, and the results could have immediate clinical implications. The trial also uses an app through which patients record doses taken, complete relevant questionnaires, and receive reminders.

Norway is one of 46 participating countries and was among the first to reach its recruitment target. When recruitment closed six months earlier than originally planned, 45 patients had been enrolled—five more than the target of 40 patients.

In addition to successful recruitment, Norway is currently performing best of all countries in terms of retention (keeping patients in the trial and on trial medication), primarily due to the way patients are received and managed at the participating trial sites.

Delivering both strong recruitment and excellent retention in competition with so many countries is noted by the trial leadership at headquarters and contributes to making Norway attractive for future trials.

The CORALreef Outcomes trial, MK0616-015, MSD

MSD’s trial “A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk” (the CORALreef Outcomes trial) evaluates an investigational medicinal product (MK-0616—an oral PCSK9 inhibitor) to determine whether it is safe and effective in reducing or delaying major cardiovascular events in participants at high cardiovascular risk. The trial is being conducted in 29 countries and is expected to continue for a further four years.

Colosseum Medical Centre (CKMS), led by principal investigator Lars Gullestad and his team, has distinguished itself in an exceptional way. The centre alone recruited 57 patients—double its original target—thereby making a major contribution to Norway not only reaching but exceeding the national target, with a total of 160 patients enrolled. Gullestad and his team have demonstrated exemplary collaboration and engagement within the department, which has been crucial for both progress and the high quality of the trial. Their efforts are a clear example of how strong teamwork and dedication can make a real difference.

This contribution strengthens Norway’s attractiveness as a host country for clinical trials, which is essential for attracting new trials to the country.

The NyreSPOT trial, AstraZeneca

AstraZeneca’s NyreSPOT trial is a national, non-interventional trial in general practice aimed at early detection of chronic kidney disease (CKD) in at-risk patients with hypertension or cardiovascular disease. CKD affects approximately one in ten adults and often causes few symptoms until the disease is advanced. Early diagnosis is therefore crucial to avoid delays in treatment and prevention.

The trial examines how guideline-based testing using both urine samples (uACR) and blood tests (eGFR) in primary care can better identify CKD in patients at increased risk. Clinical data from general practice will be combined with future data from health registries and the Fürst laboratory database to provide robust, comprehensive Norwegian data in an area with significant knowledge gaps.

The project is a collaboration between AstraZeneca (sponsor and research-responsible institution), a multidisciplinary scientific steering committee including nephrologists and a general practitioner, NordicRWE (coordinating research-responsible institution), and approximately 120 GPs across the country. More than 2,400 patients were enrolled within the expected timeframe, with planning, piloting and implementation completed rapidly thanks to strong engagement and close collaboration.

NyreSPOT is a clear example of decentralised, practice-based research that supports implementation of national guidelines and strengthens early prevention in primary care. The project demonstrates Norway’s strengths as a setting for high-quality clinical research, where broad involvement and linkage to registry data will yield relevant results. At the same time, NyreSPOT illustrates how collaboration across professional environments and industry can enhance clinical practice and create lasting benefits for patients and the healthcare system.

The Quintessential-2 trial, BMS

In Bristol Myers Squibb’s randomised Quintessential-2 trial, an entirely new type of CAR-T therapy targeting a novel surface protein (GPRC5D) is being evaluated for the first time in a randomised Phase 3 trial. The trial is for patients with multiple myeloma at first relapse, and participants are given the opportunity to receive a highly innovative treatment. The trial includes outcome measures based on patient-reported quality-of-life data.

The trial is being conducted at a total of 134 trial sites worldwide, and participation is highly sought after.

Oslo Myeloma Centre is currently the site in Europe that has enrolled the highest number of patients in the trial, attracting significant attention from BMS headquarters.

This would not have been possible without the targeted efforts of principal investigator Ingerid Weum Abrahamsen to facilitate CAR-T trials for multiple myeloma in Norway, nor without the efforts of BMS Norway to bring these trials to Norway.

In addition to being the largest site, Oslo University Hospital (OUS) was also the first site in Europe to open the trial. OUS’s strong performance clearly enhances Norway’s attractiveness as a country for clinical trials.

The text was translated from Norwegian using ChatGPT andr reviewed by Ellen Johnsen