đź“Ł ADDS Basel 2025  |  Friday, September 12, 2025

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THERAPEUTIC EXPERTISE

Solutions for Obesity and Metabolic Disorder Research

As obesity and related metabolic disorder research and development continues to grow, the need for evidence on health benefits beyond weight loss, as well as improved clinical trial design, will be critical to optimize program success, differentiate treatments, and support payer negotiations. Wearables can capture real-life mobility, physical activity, and sleep measures with minimal burden, and are crucial to support the next generation of novel treatments.

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Opportunities with Digital Measures

  • Passive, objective, and continuous real-world data of physiology and function
  • Reduce noise and improve the power of statistical analyses
  • Complement patient & clinician-reported outcomes
  • Demonstrate patient-centric benefits
  • Scalable solution for long-term follow-up studies

Indications Where DHTs Have Been Included in Clinical Development

  • Obesity
  • Type 2 Diabetes
  • Metabolic dysfunction-associated steatohepatitis (MASH)

Selected Digital Endpoints for Obesity Research

Physical Activity

  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time
  • Real-World Walk Bouts
  • Real-World 6 Minute Peak Activity
  • VO2 Max*

* VO² max measure will be developed and validated as part of DECODE-Obesity working group

Sleep

  • Total Sleep Time
  • Wake After Sleep Onset (WASO)
  • Sleep Architecture
  • Oxygen Saturation During Sleep / Hypoxia Events
Physical Activity
  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time
  • Real-World Walk Bouts
  • Real-World 6 Minute Peak Activity
  • VO2 Max*

* VO² max measure will be developed and validated as part of DECODE-Obesity working group

Sleep
  • Total Sleep Time
  • Wake After Sleep Onset (WASO)
  • Sleep Architecture
  • Oxygen Saturation During Sleep / Hypoxia Events

Digital Endpoint Guide

To learn more about opportunities with wearable digital health technologies in Obesity and Metabolic disorders clinical trials, download our full guide.

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Functional Assessments

Continuous, objective measures of physical activity are valuable data for researchers and pharmaceutical sponsors aiming to understand treatment efficacy. Increased physical activity is a key part of treatment plans for obesity and type 2 diabetes, and actual adherence impacts treatment efficacy.

Accurate assessments of physical activity can inform decision-making in early-phase trials, and be key to approval, reimbursement, and differentiation in later-phase trials.

Wearables can also provide low-burden and objective outcome assessments on physical function and sleep quality, both of which are often impacted in metabolic disorders and negatively affect quality of life, helping to differentiate therapies in a competitive landscape.

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Key Features and Benefits

  • FDA-cleared, medical-grade wearables
  • Passive, remote data collection and transfer
  • Participant adherence monitoring
  • Simple technology deployments & end-to-end operational support
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Digital Health Monthly Webinar

In this webinar, our guest experts unpack decades of research on the intersection of obesity and exercise physiology and reveal how insights from wearable digital health technologies can enhance clinical trial design and demonstrate the full health impact of emerging obesity therapies.

DECODE: Obesity

Ametris and its partners are launching a collaborative working group to enhance drug development programs in obesity. The DECODE-Obesity initiative aims to develop an evidentiary package that supports the validity of key digital measures of mobility, physical activity, and sleep impairment in the context of obesity. This includes (i) qualitative evidence on meaningfulness of the measures and human factors of the digital health technology (DHT) (ii) verification and analytical validation of the DHT (iii) health authority feedback.

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Experience in Endocrinology & Metabolic Disorder Trials

17
trials
515
sites
13
countries
2,850
participants

Let’s Connect

Have questions or need assistance? Our team is here to help. Learn more about how Ametris’s innovative solutions can support your research and patient care goals.

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