11 Patients Randomized
A vTv Therapeutics study site enrolled 11 patients into a Phase III T1D study across three site locations, with a randomization commitment at each engagement.
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Patients Randomized
$20,000
Campaign Investment
$1,818
Cost Per Randomized Patient
Sponsor
vTv Therapeutics
Drug
Cadisegliatin (TTP399), a glucokinase activator
Phase
3
Condition
Type 1 Diabetes Mellitus
Key eligibility
Age 18+, T1D diagnosis 3+ years, recent Level 2/3 hypoglycemic event within 2 months, HbA1c under 9.5%, insulin via CSII or MDI for 6+ months, CGM use for 3+ months
Site profile
3 site locations (multi-site engagement)
Registration
NCT06334133 on ClinicalTrials.gov
A Phase III Requirement in a Condition With a Narrow Patient Profile
A vTv Therapeutics study site was running a Phase III trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus, with specific eligibility requirements tied to diagnosis history and current treatment protocol.
The addressable patient pool for a T1D study on insulin is smaller than many Phase III indications. The site needed a recruitment partner who had evaluated the feasibility math before committing, not one who would invoice for activity while the enrollment gap widened.
The site needed referrals pre-screened against T1D-specific criteria and a randomization commitment that matched the site's accountability to the sponsor.
Feasibility Confirmed. Commitment Extended. Campaign Deployed.
Clinical Enroll evaluated the T1D protocol for feasibility before any campaign work began, modeling the addressable patient population, eligibility criteria complexity, and per-site enrollment targets. The commitment was confirmed supportable and formalized in contract. An IRB-compliant campaign was built and deployed across condition-targeted digital channels, with a pre-screening questionnaire aligned to the study's inclusion and exclusion criteria. Patients who did not meet the T1D-specific threshold were not referred.
11 Randomized Patients. Three Site Locations.
The campaign delivered 11 randomized patients across three site locations against a combined $20,000 investment, a cost per randomized patient of $1,818.
This was the first of several campaigns Clinical Enroll has run for this site. Repeat engagements don't happen when the first one underperforms.
Per-patient site fees for Phase III studies typically range from $8,000 to $20,000 per randomized patient depending on indication and protocol complexity. At an estimated $8,000 to $20,000 per-patient site fee, 11 randomized patients represents a potential $88,000 to $220,000 in patient revenue against a $20,000 campaign investment.
POTENTIAL ROI
$20,000
Campaign investment
$8k–$20k
Per-patient site fee range
$88k–$220k
Potential patient revenue
How Feasibility Was Verified Before Launch
Clinical Enroll evaluated the cadisegliatin T1D protocol for feasibility across all three site locations before extending a randomization commitment. Because the addressable patient pool for a T1D study on insulin is narrower than many Phase III indications, the review modeled diagnosis history, treatment protocol, and hypoglycemic-event requirements against each site's catchment area before setting per-site enrollment targets.
- Protocol and eligibility review — study criteria verified against the registered protocol, NCT06334133.
- Addressable population modeling — T1D patient density, insulin delivery method, and CGM use assessed within each site's catchment area.
- IRB-ready campaign build — condition-targeted creative and channels developed for compliance review at each site.
- Pre-screening — every referral is screened against the study's inclusion and exclusion criteria before reaching a site.
- Contracted randomization commitment — per-site enrollment targets are fixed in writing before the campaign launches.
Read more about how Clinical Enroll runs feasibility assessments before every engagement.
Common questions about this engagement.
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All campaigns developed for IRB review and deployed in accordance with FDA guidance on clinical trial advertising.