Study of Ronkyla Plus Injection for Treating Superficial Lipoma and Comparing It With Kybella Injection

What this Trial Is About

Researchers are evaluating Ronkyla Plus, a new drug that forms a hydrogel at the injection site, for treating superficial lipoma. This study aims to assess the safety, effectiveness, and how the drug moves through the body. It includes a Part I dose-escalation phase to find the highest tolerated dose, and a Part II phase to compare Ronkyla Plus to an FDA-approved injection called Kybella. In Part I, participants receive injections of Ronkyla Plus or placebo based on lipoma size, up to 10 mL per treatment, every 28 days for up to six treatments. Safety is closely monitored, including a 3-hour hospital stay after the first treatment and follow-up visits on Days 8 and 29 of each cycle. Part II involves an open-label comparison where subjects receive a single dose of Ronkyla Plus at the maximum tolerated dose or Kybella at its approved dose, followed by a 16-day pharmacokinetic assessment with scheduled blood sampling and hospital visits. Participants will undergo clinical assessments including physical exams, blood tests, and monitoring for side effects throughout the study. In Part II, detailed blood sampling occurs over 16 days to study drug levels. Additional treatments may be offered after assessment for further clearance of lipomas or submental fullness. The study measures include adverse events, changes in vital signs and lab tests, lipoma clearance rates, and participant satisfaction. Total study duration includes up to seven months for Part I and one month for Part II.

Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma