Actively Recruiting
Safety, Efficacy, and Pharmacokinetic Study of Intralesional Ronkyla Plus Injection for Superficial Lipoma Treatment
Led by Glonova Pharma Co., Ltd · Updated on 2025-12-04
56
Participants Needed
2
Research Sites
8 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
Researchers are evaluating Ronkyla Plus, a new combination drug that forms a hydrogel at the injection site, for treating superficial lipoma. The study aims to assess its safety, how well it works, and how the body processes it. This includes a dose-escalation phase to find the maximum tolerated dose and a comparison phase to evaluate its bioavailability against the FDA-approved Kybella injection for submental fullness or lipoma treatment. Part I is a randomized, double-blind, placebo-controlled study where participants receive Ronkyla Plus or placebo injections every 28 days for up to six treatments, with doses depending on lipoma size. They stay in the hospital for monitoring after the first treatment and return for safety checks on Days 8 and 29. Part II is an open-label study where eligible participants receive a single dose of Ronkyla Plus at the maximum tolerated dose or Kybella at the approved maximum dose, followed by detailed pharmacokinetic blood sampling over 16 days. After this period, additional treatments are available for further lipoma clearance or submental fullness improvement. Participants will have regular hospital visits for safety evaluations, blood tests, and physical assessments during both study parts. In Part I, safety is monitored over seven months, while Part II includes a 16-day pharmacokinetic assessment and one month of safety follow-up. Researchers will measure adverse events, changes in vital signs, blood tests, and lipoma size and appearance. Participants will also rate injection site pain. The study includes a long-term monitoring period and possible additional treatments for participants in the Ronkyla Plus and Kybella groups.
CONDITIONS
Brief Title
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males or females aged 18 to 65 years
- One or more superficial lipomas that are accessible, measurable (1 to 10 cm²), stable for at least 6 months, and confirmed by biopsy
- Or sufficient submental fat for Kybella injection (Part II Kybella cohort only)
- Body mass index between 22 and 30
- Stable body weight for at least 6 months before enrollment
- Normal healthy status based on screening assessments
- Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Ability and willingness to comply with clinic visits and study procedures
- Able to give informed consent after discussion of study risks and benefits
You will not qualify if you...
- Prior surgical treatment of target lipoma or submental area (Part II Kybella cohort only)
- Current infection or wound near target lipoma or submental area (Part II Kybella cohort only)
- History of diabetes
- Allergy to Ronkyla Plus or Kybella components (Part II Kybella cohort only)
- Clinically significant bleeding disorders or abnormal coagulation test results
- Ongoing medical conditions with bleeding risk
- Serious active infections, uncontrolled systemic diseases, significant medical or psychiatric conditions, or positive HIV/HBV/HCV status
- Use of investigational drugs or COVID-19 vaccine within 30 days before enrollment
- Abnormal liver, kidney, blood, or platelet test results
- Current or recent malignancy within 5 years
- Unlikely to complete the trial as judged by investigator
- Conditions contraindicating aspirin use or allergy to aspirin/NSAIDs
- Lipoma requiring surgical removal
- History of alcohol or drug abuse within past year (Part I dose level 2 and 4 cohorts & Part II)
- Smoking or nicotine use within 6 months prior to Day 1 (Part I dose level 2 and 4 cohorts & Part II)
- Significant blood donation or loss within 60 days prior to Day 1 (Part I dose level 2 and 4 cohorts & Part II)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive intralesional Ronkyla Plus or placebo injections at 28-day intervals for up to 6 treatments. In the first treatment cycle, participants stay in hospital for 3 hours post-treatment for safety evaluation and return on Day 8 and Day 29 of each cycle for safety assessments.
Up to 6 treatment visits every 4 weeks, each with 1 visit during the first treatment cycle requiring a 3-hour hospital stay, plus visits on Day 8 and Day 29 of each treatment cycle
Duration - 16 days
Participants receive a single intralesional treatment of Ronkyla Plus or Kybella followed by a 16-day pharmacokinetic (PK) assessment with multiple hospital visits for blood sampling and safety evaluations.
1 treatment visit and hospital visits on Day 3, 5, 8, 11, and 15 for PK assessments, plus two consecutive 24-hour PK blood sampling sessions around dosing
Duration - Variable, depending on number of additional treatments
Two weeks after the PK assessment, participants in the Ronkyla Plus group may receive up to 5 additional treatments for complete clearance of superficial lipomas. Participants in the Kybella group may receive up to 5 additional treatments with a related injection for submental fullness improvement.
Up to 5 additional treatment visits
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
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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