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NCT05763160 · ClinicalTrials.gov registry record · Phase 2
An Open-label Study That Will Test a Second Treatment Session of RZL-012.
A Phase 2 study, sponsored by Raziel Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT05763160: Completed Phase 2 study, sponsored by Raziel Therapeutics.
NCT05763160 is a Phase 2 study that has completed, run by Raziel Therapeutics. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05763160, a Phase 2 study, has completed, sponsored by Raziel Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a Phase 2, open-label study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012. The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. Subjects who fully completed either of the trials and whose C-CAT score is 2, 3 or 4 will be eligible to participate in the new trial. For each subject, the study will consist of a screening period, baseline period in which subjects will receive a second treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
Primary Outcome
Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain w
Interventions
- DRUG RZL-012
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-05-29 |
| Est. Completion | 2023-10-20 |
| Phase | Phase 2 |
What the finished NCT05763160 record still lists
NCT05763160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which RZL-012 is the first listed.
NCT05763160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05763160 about?
NCT05763160 is a clinical study titled "An Open-label Study That Will Test a Second Treatment Session of RZL-012.". This is a Phase 2, open-label study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012. The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-S...
What is the current status of trial NCT05763160?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-05-29. Estimated completion is 2023-10-20.
What interventions are being tested in trial NCT05763160?
The interventions under investigation include: RZL-012 (DRUG).
Who is sponsoring clinical trial NCT05763160?
This trial is sponsored by Raziel Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05763160's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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