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Stratification of Obesity Phenotypes to Optimize Future Therapy

Periodic Reporting for period 4 - SOPHIA (Stratification of Obesity Phenotypes to Optimize Future Therapy)

Période du rapport: 2023-06-01 au 2024-05-31

Obesity is a global pandemic, currently affecting around 150 million people in Europe and 650 million people worldwide. Obesity complications are common, in fact obesity is associated with some 200 complications, but we cannot yet predict who will develop the complications of obesity. Moreover, there are no predictors for who will respond to obesity treatments. SOPHIA will therefore identify and characterise clinically meaningful subpopulations of patients with obesity using the right treatment for the right people at the right time. The research group will use this knowledge to change how the world talks about obesity based on new understandings and a new vocabulary. It all starts with obesity being a chronic disease, not something people choose to live with. Some of the methods used in SOPHIA will be:

• Creating a database
• Conducting analysis
• Talking to patients to learn about what they fear and hope when it comes to obesity treatment
• Finding a shared value with all stakeholders to ensure better treatment of people living with obesity

We are now thirty-five leading international players from academia, industry and civil society who have joined forces to find better solutions to alleviate the burden and consequences of obesity. The project is supported with funding of €16 million from the Innovative Medicines Initiative (IMI), a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), T1D Exchange, JDRF, International Diabetes Federation (IDF), and Obesity Action Coalition.
The SOPHIA project has made significant strides in the fourth year, driven by a strong public-private partnership that has facilitated the integration of cutting-edge research with practical applications. This collaboration has enabled us to develop tools and methodologies that are transformative in the field of obesity and metabolic health research.
Key Achievements and Impactful Results:
1. Enhanced Data Infrastructure: One of the most impactful achievements this year has been the progress on our federated database, which is designed to support advanced data analysis across multiple institutions while ensuring data privacy and security. This infrastructure, is critical for enabling large-scale studies that can lead to more personalized and effective treatments for obesity-related conditions. The collaborative effort between academic and industry partners has been key in overcoming the technical and regulatory challenges associated with such a complex data-sharing platform.
2. Communication and Dissemination Success: The SOPHIA project has significantly improved its communication and dissemination activities, making our research more accessible to both the scientific community and the general public. Our newly redesigned website (www.imisophia.eu) serves as a central hub for sharing project updates, publications, and tools. Additionally, our increased activity on social media platforms like Twitter and LinkedIn has expanded our reach, leading to greater engagement and visibility within the scientific community.
3. Global Presence and Influence: SOPHIA’s presence at international conferences has been noteworthy. We successfully organized a satellite symposium at the European Congress on Obesity (ECO) in Venice, which was attended by a full room of participants, demonstrating the project's growing influence in the field. Following this success, we were invited to host another symposium at the International Congress on Obesity (ICO) in Brazil, further establishing SOPHIA as a leader in global obesity research.
4. Exploitative Activities: Our focus on exploitation is evident in the planning and execution of a dedicated workshop aimed at identifying pathways for the commercial and societal application of SOPHIA’s results. The outcomes of this workshop, which will be published in a deliverable report in November 2024, are expected to provide valuable insights and strategies for maximizing the impact of our research.
Thanks to the advocacy work in IMI SOPHIA – particularly with our work together with EASO on behalf of the SOPHIA project – the European Commission defined obesity as a “chronic relapsing disease, which in turn acts as a gateway to a range of other non-communicable diseases”.

Our federated database is considered a paradigm shift in data analysis, making replication and validation is significantly more efficient and increasing statistical power. Our utilization of this approach synergizes efforts both Europe-wide and globally and remains reusable and sustainable alongside the growth of the research field.

More broadly, the project hopes to change the narrative around obesity, to make it more patient-centric and equitable and to underline that it is a chronic disease, not something people choose to live with. This can change if pathogenesis, risk profiles for complications, and treatment responses are viewed within the context of obesity consisting of several subsets of disease. Our work has begun to identify discordant clusters among patient groups, which is the first step towards stratification and the classification of individuals according to obesity sub-types. With further validation, customized interventions can be developed to address associated risks and optimize therapeutic outcomes.

To date, little attention has been paid to the experience with, management of and access to obesity care for those living with type 1 diabetes. Our research has indicated that the prevalence of obesity among this group is similar to the population without type 1 diabetes and is thus rising alongside global obesity prevalence. Our qualitative research has and will continue to assess the experience of both these patients and the practitioners who administer their care.

By taking using a multi-lateral systems perspective, our ambitions rely on the following requirements:
1) Payers agree to fund treatment
2) Industry generates effective treatments
3) Clinicians are prepared to prescribe treatment
4) Patients are prepared to take treatments

By mapping out where these barriers lie and identifying potential points of entry, we will be able to focus our implementation and impact efforts more precisely. With this, we not only address the challenges to overall wellbeing and gaps in care, but we can also use this to further inform the evaluation of patient-related outcomes and ensure that treatment pathways are patient-centric and tailored to the individual’s real experience.
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