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NCT06964087 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
A Phase 2 study of Type I Diabetes, sponsored by Op-T.
- Active
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT06964087: Active Phase 2 study of Type I Diabetes, sponsored by Op-T.
NCT06964087 is a Phase 2 study of Type I Diabetes that is active but no longer recruiting, run by Op-T. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06964087, a Phase 2 study of Type I Diabetes, is active but no longer recruiting, sponsored by Op-T.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.
Primary Outcome
Change from baseline to End of Study in mixed-meal stimulated C-peptide (ng/mL). The area under the time-C-Peptide curve (AUC) is calculated, and the weighted mean C-peptide is used to convert the measurement back to nanomoles per liter.
Conditions Studied
Interventions
- DRUG OPT101
- OTHER OPT101 Placebo to Match (PTM)
Study Locations (1)
Washington
- Rainier Clinical Research Center - Renton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-05-27 |
| Est. Completion | 2028-08-19 |
| Phase | Phase 2 |
What the registry record for NCT06964087 still lists
NCT06964087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Type I Diabetes appearing as the primary indexed condition, and to 2 interventions - of which OPT101 is the first listed.
NCT06964087 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT06964087 about?
NCT06964087 is a clinical study titled "Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus". This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.
What is the current status of trial NCT06964087?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2025-05-27. Estimated completion is 2028-08-19.
What conditions does trial NCT06964087 study?
This clinical trial studies the following conditions: Type I Diabetes.
What interventions are being tested in trial NCT06964087?
The interventions under investigation include: OPT101 (DRUG), OPT101 Placebo to Match (PTM) (OTHER).
Who is sponsoring clinical trial NCT06964087?
This trial is sponsored by Op-T, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06964087 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type I Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06964087's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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