As obesity and type 2 diabetes mellitus (T2DM) continue to pose major public health challenges, up to 90% of adults with T2DM are classified as overweight or obese. Consequently, the demand for clinical trials to evaluate innovative therapies within tight operational windows and highly specific patient populations is at an all-time high. Evaluating treatments at the intersection of metabolic dysfunction, glycemic control, and weight management requires site networks capable of executing complex, long-term, and restrictive protocols without compromising speed or data integrity. In a recent U.S. Phase 3 trial targeting this exact patient population, DelRicht Research demonstrated how specialized site infrastructure and rapid activation can dramatically accelerate trial timelines while exceeding targets.

Exceeding Enrollment Goals

DelRicht Research was selected as a participating site network for a U.S. Phase 3 obesity and type 2 diabetes study enrolling patients ≥18 years old. The study aimed to enroll patients with obesity and T2DM without a history of hormone or incretin-based therapies. In addition, qualifying patients needed to have had 3 months of stable HbA1c values within a specific threshold to participate. Our network was projected to enroll 11 patients across 2 general medicine sites:

   • Dr. Luke Van Kirk of Command Family Medicine | Springfield, MO
   • Dr. Robert Springer of Springer Wellness and Restorative Health | Atlanta, GA

During study start-up, both sites were able to achieve a rapid 1-day activation to screening timeline, setting the tone for successful recruitment. By enrollment close, our Springfield, MO and Atlanta, GA sites collectively enrolled 33 qualified patients, accomplishing 300% of our expected enrollment goal. While the median study enrollment was 1.1 patients per site per month, DelRicht maintained 3.3 patients per site per month.

These achievements highlight the efficiency of DelRicht’s embedded research model and the collaboration between experienced investigators and dedicated site teams.

Overcoming Recruitment and Patient Burden Challenges

Evaluating therapeutics across the 99-week study duration presented unique challenges in restrictive recruitment criteria and patient burdens that are inherent to long-term cardiometabolic studies:

Restrictions & Exclusion Criteria
Requirements like T2DM diagnosis ≥6 months prior to study start, specific HbA1c thresholds with stable management, combined with the exclusion of widespread popular hormone and incretin therapies significantly limited the eligible patient pool. To address these recruitment hurdles, our sites leveraged recruitment strategies such as existing referral networks and verified electronic health records to pre-screen qualifying T2DM patients. Additionally, utilizing the protocol provision to recheck borderline lab results minimized screen failures.

Patient Burden & Engagement
The frequency of monthly visits over the duration of the study compounded with weekly self-injections, fasting blood sugar checks, routine blood tests, gastrointestinal side effects, and busy patient schedules, created multiple layers of patient fatigue and attrition. Our site teams employed a multi-faceted approach to secure long-term engagement while minimizing patient burden:

   • Patient-centered education on placebo expectations and side effects
   • Flexible visit workflows and telehealth when permitted
   • Automated visit and medication reminders
   • Dedicated coordinators for outreach follow-up and familiarity

These proactive measures ensured enrollment and long-term patient engagement over the demanding 23-month trial. DelRicht Managing Partner, Tyler Hastings added:

“Navigating multi-year cardiometabolic protocols with strict exclusion criteria requires an operational framework that anticipates patient fatigue before it happens. Outperforming industry enrollment benchmarks by 3x in this Phase 3 study demonstrates that when you combine deep EHR integration with proactive, patient-centered care, you don’t have to choose between strict protocol adherence and rapid trial execution.” – Tyler Hastings, Managing Partner at DelRicht Research

Partnering in Cardiometabolic Research

Advancing next-generation therapies for patients living with obesity and T2DM requires an operational framework built on rapid start-up, patient-first engagement, and rigorous data quality assurance. DelRicht Research continues to exceed enrollment targets and move medicine forward across general medicine research.

If you’re planning an upcoming cardiometabolic trial, our network is prepared to deliver speed, scale, and uncompromising precision. Visit www.DelRichtResearch.com or contact our business development team to start the conversation.