As obesity rates rise worldwide, clinical trial teams face growing pressure to show treatment benefits that go beyond weight loss alone. With projections suggesting that nearly half of adults will have a high BMI within the next decade, researchers must not only develop effective therapies but also define clinical trial endpoints that reflect real improvements in patient well-being.1
Clinical Outcome Assessments (COAs) and Digital Health Technologies (DHTs) give researchers a more holistic understanding of treatment impact: how patients feel, function, and live. Integrating these tools can make obesity clinical trials more patient-centered, scientifically robust, and aligned with evolving regulatory expectations.
The limitations of weight-centric endpoints
For decades, obesity clinical trials have focused on endpoints such as percentage of weight loss or improvement in comorbidities. But as GLP-1 receptor agonists have gained traction, researchers have discovered a problem: patients often lose muscle mass, potentially harming overall health despite lower body weight.
This underscores the limits of weight as a stand-alone outcome. Over the past decade, studies have started to include patient-centered endpoints such as:
- Quality of life
- Physical function and mobility
- Mental health and mood
- Sleep and energy levels
- Eating behaviors and work productivity
These outcomes are often measured using Patient-Reported Outcomes (PROs) like the IWQOL-Lite-CT, Short Form-36 (SF-36), and Patient Health Questionnaire-9 (PHQ-9).2 Both the FDA and EMA now emphasize the inclusion of PROs in labeling submissions, thus reinforcing that meaningful success in obesity trials must reflect both clinical change and patient experience.
A shift in regulatory expectations
Regulators are increasingly signaling a multidimensional approach to obesity research. The FDA’s recent guidance, released in January 2025, encourages sponsors to go beyond traditional efficacy endpoints and include assessments that address physical function and neuropsychiatric health, using fit for purpose COAs such as the PHQ-9 and Columbia Suicide Severity Rating Scale (C-SSRS).3 For sponsors, this marks an important evolution: It is no longer enough to demonstrate only what changes on the scale.
By aligning COA selection with both regulatory guidance and patient priorities, sponsors can strengthen the interpretability and impact of their trial results.
The patient perspective: what truly matters
Although current regulatory guidance supports the inclusion of PROs, it does not specify which measures are most appropriate. To fill that gap, the Standardise Quality of Life Measurement in Obesity Treatment (S.Q.O.T.) initiative convened patients, clinicians, and researchers to identify what outcomes people living with obesity value most.
Through literature reviews, international surveys, and consensus workshops, the group pinpointed 25 key concepts and 17 validated Patient-Reported Outcome Measures (PROMs). The findings revealed that patients prioritize:
- Self-esteem
- Body image
- Energy levels
- Social participation and confidence
While clinicians often focus on physical and mental health domains, patients repeatedly emphasize the psychological and social dimensions of obesity. This reinforces a key insight: True treatment success is not simply about clinical efficacy, but also about meaningful change in the aspects of life patients value most.
The expanding role of digital health technologies (DHTs)
DHTs are rapidly reshaping how obesity outcomes are captured and analyzed. Tools such as wearable sensors, connected scales, continuous glucose monitors, and blood pressure trackers enable continuous, real-world measurement of health metrics like activity level, sleep, and metabolic function.
When thoughtfully integrated with COAs, DHTs provide a data-rich, multidimensional view of treatment benefit. This approach allows researchers to correlate objective physiological data with subjective patient feedback, resulting in more complete and credible evidence.
The FDA’s 2023 DHT guidance underscores that digital endpoints must be fit for purpose and validated using frameworks such as V3+, ensuring that digital tools meet the same scientific and regulatory standards as traditional COAs.4
Integrating COAs and DHTs for better trials outcomes
By combining COAs and DHTs, sponsors can achieve a comprehensive understanding of treatment impact that reflects both patient perspective and clinical rigor. Lessons from other therapeutic areas, such as COPD, demonstrate that hybrid approaches can capture both the quantity and quality of patient activity, leading to more actionable insights and more compelling evidence for regulators.
For obesity clinical trials, this integrated approach offers multiple advantages:
- Stronger alignment with regulatory expectations
- Enhanced credibility and interpretability of endpoints
- Deeper understanding of real-world patient outcomes
- Greater potential for labeling claims and differentiation
Ultimately, this is about seeing beyond the scale, measuring not only what patients lose, but what they gain back in energy, confidence, and quality of life.
Learn more
To explore how to design obesity trials that integrate COAs and DHTs effectively, please reach out to our team.
1 World Obesity Federation. “World Obesity Atlas 2024.”
2 Goetz IA, Sutter C, Abraham T, Kanu C, Boye KS, Symonds T. ”The evaluation of clinical outcomes assessments and digital health technologies in clinical trials for obesity.“ J Patient Rep Outcomes. 2025 Feb 20;9(1):23.
3 Food and Drug Administration. Guidance Document: Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/obesity-and-overweight-developing-drugs-and-biological-products-weight-reduction
4 U.S. Food and Drug Administration. “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance for Industry, Investigators, and Other Stakeholders. Guidance for Industry