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NCT06812988 · ClinicalTrials.gov registry record · Phase 2
Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT06812988: Active Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
NCT06812988 is a Phase 2 study of Type 1 Diabetes Mellitus that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 84 participants, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06812988, a Phase 2 study of Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) on insulin therapy. The study design comprises 2 parts: in Part A adult participants (18 to 35 years of age at screening) and in Part B adolescent and young adult participants (age range 12 to 21 years) will be randomized into brivekimig and placebo groups. Approximately 84 participants will be included with randomization ratio 3:1 (active:placebo). The study includes a screening period (3 to 5 weeks), a double-blind treatment period of 52 weeks and a safety follow-up of 26 weeks.
Primary Outcome
Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Brivekimig
Study Locations (20)
Other
- Investigational Site Number : 0320001 - Buenos Aires
- Investigational Site Number : 0320002 - Buenos Aires
- Investigational Site Number : 0320005 - Buenos Aires
- Investigational Site Number : 0320004 - Buenos Aires
- Investigational Site Number : 0320003 - Salta
- Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760002 - São Paulo
Georgia
- Atlanta Diabetes Associates- Site Number : 8400006 - Atlanta
- IACT Health - Columbus - Talbotton Road- Site Number : 8400012 - Columbus
British Columbia
- Investigational Site Number : 1240006 - Surrey
- Investigational Site Number : 1240001 - Vancouver
Reg Metropolitana de Santiago
- Investigational Site Number : 1520003 - Providencia
- Investigational Site Number : 1520001 - Santiago
Michigan
- Profound Research - MHP - TriAtria- Site Number : 8400015 - Farmington Hills
Texas
- Tekton Research - McKinney- Site Number : 8400017 - McKinney
Utah
- Advanced Research Institute - Odgen- Site Number : 8400007 - Ogden
New South Wales
- Investigational Site Number : 0360003 - Saint Leonards
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2027-04-29 |
| Phase | Phase 2 |
What the registry record for NCT06812988 still lists
NCT06812988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06812988 names 20 study sites across 12 states, led by Other, Georgia, British Columbia.
Frequently Asked Questions
What is clinical trial NCT06812988 about?
NCT06812988 is a clinical study titled "Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule". This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabe...
What is the current status of trial NCT06812988?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2025-02-28. Estimated completion is 2027-04-29.
What conditions does trial NCT06812988 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT06812988?
The interventions under investigation include: Placebo (DRUG), Brivekimig (DRUG).
Who is sponsoring clinical trial NCT06812988?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06812988 being conducted?
This trial has 20 study locations across Georgia, Michigan, Texas, Utah, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
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 NCT06812988's enrollment target sits among peer trials
84 36th of 112 higher than 77 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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.
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