# A NOVEL PRECISION MEDICINE APPROACH FOR OBESITY: A RANDOMIZED, MULTI-CENTER TRIAL

> **NIH NIH R44** · PHENOMIX SCIENCES, LLC · 2024 · $996,003

## Abstract

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Obesity is a chronic, relapsing, and multifactorial disease,[1] with a prevalence of 42%.[2] As with any obesity treatment, the weight loss response with anti-obesity medications (AOMs) is highly variable. For example, semaglutide 2.4 mg, the most effective AOM leads to a mean total body weight loss (TBWL) of 15% in randomized clinical trials[3] and in real-world clinic cohort studies.[4] However, only 50% of participants achieve >15% in one year,[3] whereas 30% lose less than 10% TBWL. In the clinical practice, access to AOMs can be limited by their high cost. Importantly, given the variable weight loss response to AOM, these may not be cost-effective, particularly in poor responders who will not only incur unnecessary high costs, but will also be exposed to possible side effects. Currently, besides identifying responders by trial-and-error,[5, 6] little is known about the predictors of response to AOM, and the heterogeneous response to this type of intervention, remains an important challenge in clinical practice.[1, 7] There is a critical need to identify the predictors of response to AOM to develop individualized weight-loss strategies that enhance weight loss outcomes in people with obesity.[8] 
Our team focuses on understanding the heterogeneity of human obesity by identifying predictors of response to weight loss treatments.[9] Phenotyping of 880 adults has demonstrated that there are phenotypic traits that differentially respond to weight loss interventions. One of these phenotypic traits is abnormal postprandial satiety.[10] Patients with abnormal postprandial satiety have increased postprandial hunger, which is associated with accelerated gastric emptying.[11] To date, we have shown that lifestyle interventions, AOMs, and endoscopic devices targeting this underlying phenotypic trait enhance weight loss outcomes in patients with obesity.[10, 12-20] Our data suggest that the phenotype-tailored approach could become a clinical approach for the treatment of obesity, whereby individual patients are matched to treatments directed at the underlying phenotype. However, the current methods used to identify phenotypes are time-consuming, invasive, expensive, limited to a few academic centers, and not generally accessible for most patients. 
To address these limitations, an academic-industry partnership was established, and we have developed and validated a novel blood- and saliva-based biomarker test of appetite regulation in obesity that predicts the abnormal postprandial satiety phenotype. The current biomarker, named MyPhenomeTM test, is ready for commercialization in a CLIA-CAP accredited laboratory; and it will be scalable and affordable to support healthcare providers to guide patients to tailored anti-obesity treatments. Our aim is to study, in a multi-center, 24-week, prospective, randomized, double-blind, placebo-controlled trial, the efficacy of subcutaneo...

## Key facts

- **NIH application ID:** 10821885
- **Project number:** 1R44DK138619-01
- **Recipient organization:** PHENOMIX SCIENCES, LLC
- **Principal Investigator:** Mark Bagnall
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $996,003
- **Award type:** 1
- **Project period:** 2024-03-15 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10821885

## Citation

> US National Institutes of Health, RePORTER application 10821885, A NOVEL PRECISION MEDICINE APPROACH FOR OBESITY: A RANDOMIZED, MULTI-CENTER TRIAL (1R44DK138619-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10821885. Licensed CC0.

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