Actively Recruiting
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Led by Glonova Pharma Co., Ltd · Updated on 2025-12-04
56
Participants Needed
2
Research Sites
60 weeks
Total Duration
On this page
Sponsors
G
Glonova Pharma Co., Ltd
Lead Sponsor
T
T-TOP Clinical Research Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 65 years
- One or more superficial lipomas accessible for treatment, stable for at least 6 months, sized between 1 and 10 square centimeters, discrete and oval to rounded, located on trunk, arms, legs, or neck, with biopsy confirming lipoma
- OR sufficient submental fat for Kybella injection (Part II Kybella group only)
- Body mass index between 22 and 30
- Stable body weight for at least 6 months
- Normal healthy status based on screening assessments
- Females of childbearing potential must have a negative pregnancy test within 28 days before enrollment and use effective contraception during the study
- Postmenopausal or surgically sterile females considered not of childbearing potential
- Able and willing to comply with clinic visits and procedures
- Capable of understanding and signing informed consent
You will not qualify if you...
- History of surgical treatment for the target lipoma or submental area (Part II Kybella group only)
- Current infection or wound near the target area (Part II Kybella group only)
- History of diabetes
- Allergy to Ronkyla Plus or Kybella ingredients (Part II Kybella group only)
- Clinically significant bleeding disorders or abnormal coagulation tests
- Medical conditions with significant bleeding risk
- Active serious infections, severe uncontrolled systemic diseases, HIV/HBV/HCV infection, or significant lab abnormalities
- Use of investigational drugs within 30 days
- COVID-19 vaccination within 30 days
- Abnormal liver or kidney function or blood counts outside normal limits
- Current or recent malignancy within 5 years
- Unlikely to complete the trial
- Contraindications to aspirin or NSAIDs, or use of these medications near enrollment
- Lipoma requiring surgical removal
- History of alcohol or drug abuse in the past year (Part I dose level 2,4 and Part II)
- Smoking or nicotine use within 6 months (Part I dose level 2,4 and Part II)
- Significant blood loss or donation within 60 days (Part I dose level 2,4 and Part II)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cathay General Hospital
Taipei, Da'an District, Taiwan, 106436
Actively Recruiting
2
Cathay General Hospital Sijhih Branch
New Taipei City, Sijhih District, Taiwan, 22174
Actively Recruiting
Research Team
H
Helen Wang, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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