Clinical Trial

Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of superficial lipoma. The study consists of a Part I dose-escalation study to investigate the drug's maximum tolerated dose (MTD) for this indication and a Part II study for evaluating its relative bioavailability in comparison to an FDA-approved lipolysis injection, Kybella.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-11-14 -> 2028-05-31 2026-07-29
minor Completion pushed: 2027-01-14 -> 2028-08-31 2026-07-29
Trial Details
NCT Number NCT07237425
Lead Sponsor Glonova Pharma Co., Ltd
Collaborators: T-TOP Clinical Research Co., Ltd.
Conditions Lipoma, Submental Fullness
Enrollment 56 participants
Start Date 2025-11-14
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28