DECODE: Obesity

The Problem

Obesity is a worldwide epidemic with projections estimating that obesity will affect over half the global population by 2035³. Obesity negatively impacts a person’s quality of life by limiting physical function and sleep quality. Patients with obesity are more likely to develop sleep apnea, digestive problems, osteoarthritis, type 2 diabetes and have an increased risk of life-threatening chronic conditions such as heart disease and certain cancers.

With the 2021 approval of Wegovy for weight management therapies⁴, interest in developing obesity treatments has grown significantly, with over 100 ongoing clinical trials in this indication⁵.

However, this breakthrough in obesity treatment has not come without challenges:

• Physical activity is a cornerstone of chronic weight management solutions, including GLP-1 treatments, but has not been well quantified in previous GLP-1 trials.
• The percentage of lean muscle loss is a significant concern with GLP-1 obesity treatments and could potentially lead to short term and long term adverse effects, suggesting that the current focus on weight loss alone as a primary clinical endpoint is insufficient to demonstrate meaningful health benefits.
• Payers have started pushing back on cost and duration of treatments⁶, and benefits beyond weight loss are likely to be more critical for payer negotiation in the future.

1. https://theactigraph.com/decode/nocturnal-scratch

2. DECODE : Digital Endpoint Collaboration for Outcomes DEvelopment

3. World Obesity Atlas 2024

4. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=62112

5. www.clinicaltrials.gov

6. https://www.nice.org.uk/guidance/ta875/chapter/1-Recommendations

The Solution

Wearable digital health technology (DHT) offers a direct assessment of functioning with minimal patient burden. Data from wearable DHTs provide objective measures of physical activity as an important covariate in obesity clinical trials, and additional clinically meaningful outcome measures to assess efficacy for obesity treatment.

The DECODE Obesity working group will focus efforts in three areas:

1. A Clinical Study tailored to the partners needs to generate evidence on:
   • Physical Activity measures as a covariate
   • Physical Function measures as a clinical endpoint
   • Sleep measures as a clinical endpoint
2. Patient Engagement to better characterize:
• Voice of the Patient to report impact of obesity on their daily life and perspectives on treatment
• Usability
3. Regulatory Engagement to get buy in from EMA and FDA

Working Group Details

Pioneer Pharmaceutical partners joining the working group will benefit from:

• The ability to influence the design of the clinical studies and access to all clinical data generated
• Participation in regulatory engagement with the EMA and the FDA
• Full evidentiary dossier to support validity of the measure in specific partner’s context of use
• Staying at the forefront of innovation in drug development programs for obesity treatments

The projected timeline for the DECODE-Obesity initiative includes the following key milestones:

• Finalizing Working Group Scope: Q3 2024
• Contracting: Q4 2024
• Working Group Kick Off Meeting: Q1 2025
• Working Group Finalization: ~Q4 2025