Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT06964087. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients With Recent Onset Type 1 Diabetes Mellitus
Study identification
- NCT ID
- NCT06964087
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Op-T LLC
- Industry
- Enrollment
- 72 participants
Conditions and interventions
Conditions
Interventions
- OPT101 Drug
- OPT101 Placebo to Match (PTM) Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 9, 2026
- Primary completion
- May 30, 2026
- Completion
- Aug 18, 2028
- Last update posted
- Apr 5, 2026
2026 – 2028
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - Department of Medicina | Birmingham | Alabama | 35294 | Recruiting |
| Diablo Clinical Research Center | Walnut Creek | California | 94598 | Recruiting |
| Barbara Davis Center - University of Colorado Anschuttz Medical Campus | Aurora | Colorado | 80045 | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Recruiting |
| Rainier Clinical Research Center | Renton | Washington | 98057 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06964087, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06964087 live on ClinicalTrials.gov.