Every week, strong sites ask me the same question: how do we win our first glucagon-like peptide-1 (GLP-1) trial when every feasibility questionnaire asks for prior GLP-1 experience? I am Julio G.
November 6, 2026
7
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
The mistake: answering a risk question with enthusiasm
A feasibility questionnaire is a risk screen. When a sponsor asks about prior indication experience, they are really asking four narrower questions. Can you find eligible patients quickly? Can you keep them coming back for months of frequent visits? Can your team manage metabolic safety monitoring and dose-escalation schedules without missing signals? And can you start fast enough to matter to the enrollment timeline?
"We are very interested in GLP-1 and our patients are asking about it" answers none of those questions. Motivation is not scarce. Documented performance in adjacent work is. If you come from orthopedics, rheumatology, cardiology, endocrinology, or primary care, translate that record into the language sponsors trust: enrollment rates, screen-failure reasons, retention percentages, and startup timelines from comparable populations.
Do not claim experience you do not have. Sponsors verify, and a single exaggerated line will cost you more than one study. It will cost you the next five.
Evidence one: adjacent cardio-metabolic enrollment
Start with what you have already enrolled, not with what you hope to enroll.
Pull your last three to five years of enrollment in adjacent cardio-metabolic areas: type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk reduction, chronic kidney disease with metabolic components, and obesity-adjacent conditions such as osteoarthritis or inflammatory disease where weight and mobility were central to the patient profile. A rheumatology site, for example, often manages patients with obesity, metabolic syndrome, and cardiovascular comorbidity every day, even if it has never dosed a GLP-1 therapy. An orthopedics site preparing patients for joint replacement routinely works with weight thresholds, glycemic control, and structured follow-up.
Present that history in a simple table: therapeutic area, number of studies, patients screened, patients enrolled, enrollment rate per month, and completion rate. Add your top screen-failure reasons. A site that knows why its patients fail screening looks far more credible than a site that reports perfect numbers no experienced sponsor believes.
At Amavita Research Services, we lead with exactly this kind of adjacency. Our base is cardiovascular, with more than 18,000 active cardiology patients and zero United States Food and Drug Administration (FDA) Form 483 findings. That record does not make us a GLP-1 site by itself. It does prove sustained access to a cardio-metabolic population, disciplined source documentation, and inspection-ready operations — which is the foundation a sponsor is actually evaluating.
Evidence two: a de-identified count of your own eligible patients
This is the single most persuasive item a site without indication experience can produce, and the one most sites skip because they think it requires a protocol. It does not.
Run a de-identified query of your own electronic health record (EHR) system against typical GLP-1 trial eligibility, framed generically. For weight-management studies, that usually means adults in defined body mass index (BMI) bands — for example, BMI of 30 or higher, or BMI of 27 or higher with a weight-related comorbidity such as hypertension or dyslipidemia. For type 2 diabetes studies, it usually means adults with glycated hemoglobin (HbA1c) in a moderately elevated range despite standard therapy, stable background medication, and no recent change in treatment.
Report only aggregate counts. No patient-level data leaves your system. What you hand a sponsor is a funnel: total patients in the relevant BMI or HbA1c band, minus those excluded by common criteria, equals a realistic eligible pool. Then state how many your team could contact in the first 30, 60, and 90 days.
That funnel changes the conversation. "We have a large database" is a claim. "We have 1,400 de-identified patients in the BMI band, approximately 900 after common exclusions, and capacity to contact 300 in the first month" is evidence — use your own real numbers in that format, whatever they are.
Evidence three: principal investigator oversight in metabolic care
Sponsors screen the principal investigator (PI) for judgment, not just for a publication list in the exact indication.
Document your PI's metabolic-care oversight directly: years managing patients with diabetes, obesity, and cardiovascular risk, experience with therapies that require titration and tolerability monitoring, and prior PI or sub-investigator roles on trials with metabolic endpoints or long treatment periods. Add delegation structure and who provides medical coverage between visits.
If your PI has a gap, name the mitigation instead of hiding it. A named sub-investigator with endocrinology experience, a dietitian embedded in the visit workflow, or a formal consultation arrangement is a credible answer. An unacknowledged gap is not.
Evidence four: visit cadence and retention infrastructure
GLP-1 trials are retention trials. Treatment periods are long, visits are frequent, dose escalation takes time, and early gastrointestinal side effects cause participants to disappear in the first weeks if nobody is watching closely. Sponsors know this, and they screen for it harder than they screen for indication history.
Describe your infrastructure in operational terms. How do you remind participants, and how many touches happen before a visit? Can working participants come early, late, or on weekends? What is your missed-visit recovery process? Who calls a participant who reports nausea, and within what timeframe? What transportation, parking, and language barriers have you already solved for other long trials?
Then attach your retention numbers from your longest, most visit-intensive studies. A site that retained 90 percent of participants through a twelve-month, monthly-visit trial has already answered the GLP-1 retention question, regardless of the drug class involved.
Evidence five: startup speed
In a competitive indication, a site that can start in five weeks often beats a more experienced site that needs twelve. Document your real timeline: contract and budget turnaround, institutional review board (IRB) timing, pharmacy and laboratory readiness, and days from selection to first patient screened on your last three studies. If you work with bioaccess anywhere from Canada down to Argentina, that same discipline applies — speed is documented, not promised.
How to assemble the one-page capability case
Put all of it on one page. Not a slide deck, not a generic brochure — one page, in this order:
- Header: Site name, location, PI name, and the therapeutic areas where you are actively seeking GLP-1 opportunities.
- Adjacent enrollment table: Three to five comparable studies with screened, enrolled, and completed numbers, plus enrollment rate per month.
- Eligible-patient funnel: Your de-identified EHR count by BMI band or HbA1c range, after common exclusions, with your 30-, 60-, and 90-day contact capacity.
- Oversight: Two or three lines on PI and sub-investigator metabolic-care experience, plus any named mitigation for gaps.
- Retention infrastructure: Your best retention result on a long trial, and three concrete systems that produced it.
- Startup timeline: Your documented days from selection to first patient screened, with the fastest recent example.
- Quality line: Inspection and audit history, stated factually. Ours reads zero FDA Form 483 findings. State yours exactly as it is.
Send that page with the completed feasibility questionnaire, not instead of it. Answer every questionnaire question honestly, including the direct "no" on prior GLP-1 studies, and let the page carry the transferable evidence beside it.
The honest close
You do not break into a hot indication by pretending to be something you are not. You break in by showing a sponsor that the risks they actually carry — finding the patient, keeping the patient, overseeing the patient safely, and starting on time — are risks you have already managed, with numbers. Build that one page from your real record this week. It will do more for your first GLP-1 award than a year of saying you are interested.
Julio G. Martinez-Clark is chief executive officer (CEO) of bioaccess\u00AE, a first-in-human contract research organization running early-phase trials anywhere from Canada down to Argentina, and of Amavita Research Services, a Miami cardiovascular research site he has operated for seven years with zero United States Food and Drug Administration (FDA) Form 483 inspection findings. He founded Global Trial Accelerators\u2122, a podcast for medtech and biotech founders navigating first-in-human studies.