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Quick tags:
- Sponsor:
Biohaven Therapeutics
- Indication:
Obesity
- Specialty:
Endocrinology
- Type:
Drug (Biologic)
- EHR:
Practice Fusion & eClinicalWorks
Site Network Description
Flourish Research is a clinical research network spanning cardiovascular, metabolic, kidney, neuroscience, infectious disease, and oncology trials across multiple U.S. markets. Their regional sites operate through a hub-and-spoke model: a central research site coordinates with community-based partner clinics to bring clinical trials directly to patients in local neighborhoods.
For BHV2000-202, Flourish deployed HealthKey across four partner clinics in the Chicago area, each running on a different EHR configuration. The network model means coordinators are screening patients across multiple physician practices simultaneously, making manual chart review across thousands of records virtually impossible at the pace competitive enrollment demands.
Trial Description
BHV2000-202 (NCT07281495) is a Biohaven Therapeutics trial evaluating whether subcutaneously administered taldefgrobep alfa (BHV-2000) can safely reduce body weight in adults living with overweight or obesity. This Phase 2b trial compares BHV-2000 (given weekly or every four weeks) with placebo in a blinded, randomized study across 20 U.S. sites, followed by an open-label extension. The global enrollment target is 150 patients.
The primary endpoint is percent change in total body weight from baseline to Week 24. Secondary endpoints include changes in total fat mass and lean mass, plus safety outcomes such as adverse events and laboratory abnormalities through Week 24.
Taldefgrobep alfa is an investigational myostatin-pathway inhibitor designed to improve muscle and shift body composition. Unlike GLP-1 receptor agonists that drive overall weight loss (often including significant muscle mass), taldefgrobep targets fat loss while preserving or increasing lean mass.
“Together these posters support the development of taldefgrobep as a novel therapy for the treatment of overweight and obesity that can result in significant fat loss while increasing lean mass. This is a paradigm-shift from traditional obesity therapies that focus on overall weight loss despite significant difficult to reverse loss in muscle mass.”
Irfan Qureshi, M.D., Chief Medical Officer at Biohaven Therapeutics
Challenge
Flourish was contracted to enroll up to 5 patients in a competitive enrollment model across all participating sites. These potentially eligible patients were scattered across four separate partner clinics, buried in thousands of charts, lab results, and provider notes spread across two different EHR systems.
The eligibility criteria made manual screening exceptionally difficult. Patients were included only if they had BMI between 30 and 42 kg/m2, or BMI between 27 and 30 with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight. Patients also needed stable body weight and stable physical activity within 3 months prior to screening.
Patients were excluded if they had any history of diabetes (including individuals with an HbA1c of 6.5% or higher at screening), were non-ambulatory, or were concurrently taking both an ARB and an ACE inhibitor.
These details lived across encounters, labs, medications, and provider notes. A coordinator might find a patient with BMI 31 and documented weight-related comorbidities, then discover in a lab result from two months ago that their HbA1c was 6.6%, just over the cutoff. Multiply that across four clinics and 11,000 patients, and manual review becomes untenable.
With a wave of obesity trials arriving simultaneously, Flourish needed a way to pre-screen patients at scale and route them to the right study.
Solution
Flourish connected HealthKey to four partner clinics running Practice Fusion and eClinicalWorks. Setup took minutes per clinic. Coordinators shared the trial protocol, and HealthKey's white-glove onboarding service translated the 32 inclusion and exclusion criteria into logic the AI could apply across both structured and unstructured data.
HealthKey processed all four clinics in parallel: 11,041 patients, over 4.1 million medical records, and 63,515 individual criteria evaluations. Each match included supporting evidence: weight measurements showing BMI within range, encounter notes documenting weight-related comorbidities and prior dietary efforts, lab results confirming HbA1c levels below the exclusion threshold, and clinical assessments verifying ambulatory status.
Patients who met most criteria but had edge cases were flagged for manual review. Maybe the BMI was at the boundary, the HbA1c timing was unclear, or the documentation of prior dietary efforts was ambiguous. Flourish's research team screened HealthKey's results and moved patients through their review pipeline within hours.
"My team loves using HealthKey, and this makes everyone's job easier. HealthKey is able to do something that nobody else has been able to do."
Caileen Collins, Physician Relations Account Manager at Flourish Research
The Results
11,041 patients screened and 4.2 million medical records processed across 4 clinics.
HealthKey screened 11,041 patients and processed 4,187,984 medical records across four partner clinics in parallel, evaluating each patient against 32 eligibility criteria. For Flourish's clinical research team, manually reviewing this volume would have required approximately 3,312 hours, or over 414 full working days.
74 eligible patients identified, 2 enrolled in 25 days.
Across all four clinics, HealthKey identified 323 patients who met all prescreening criteria and were seen in the last 180 days. Flourish's coordinators screened 175 of those patients, passing 74 in the first month. Two patients enrolled within 25 days of screening launch, against a competitive enrollment target of 5 across all participating sites.
"Anyone who's not using something like HealthKey, they're going to probably triple, quadruple their screen failure rates. We have checked the back history on their medical records. They're going to find all the things that weren't self-reported when they get those medical records back, where when we give our medical records, we can just proceed to screening and randomization."
Christopher Zomerfeld, Clinical Research Coordinator at Flourish Research
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Over 3,300 hours of manual chart review saved.
Processing 11,041 patients across four clinics and two EHR systems would have required an estimated 3,312 hours of manual review. HealthKey completed the same work in a fraction of that time, freeing coordinators to focus on patient outreach, scheduling, and the clinical screening process itself.
Looking Ahead
Flourish Research has made HealthKey a core part of its clinical trial recruitment infrastructure. The organization has now deployed HealthKey across 10 sites and continues to expand into new therapeutic areas across dozens of studies.
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