MedTrace Logo

Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

NCT07237425 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

  • Lipoma
  • Submental Fullness

Interventions

DRUG

Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.

DRUG

Placebo

Normal saline for injection.

DRUG

Kybella

10 mg/mL deoxycholic acid injection

Sponsors & Collaborators

  • T-TOP Clinical Research Co., Ltd.

    collaborator INDUSTRY

  • Glonova Pharma Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yu-Hsiu Yen, MD · Cathay General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2026-11-14
Completion
2027-01-14
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237425 on ClinicalTrials.gov