Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma (NCT07237425) | Clinical Trial Compass
RecruitingPhase 1
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Taiwan56 participantsStarted 2025-11-14
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male or female adults aged 18 to 65 years, inclusive.
. One or more superficial lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
. Body mass index (BMI): BMI between 22 to 30 (normal, overweight and slight obese).
. History of stable body weight, in the judgment of the investigator, for at least 6 months before enrollment.
. The health status is assessed by the investigator as "normal healthy" based on required screening assessments.
. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before enrollment and agree to use a highly effective method of contraception from enrollment up to the study end, such as:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part I: Incidence of all adverse events
Timeframe: 7 months (Part I); 1 month (Part II)
2
Part I: Incidence of all serious adverse events
Timeframe: 7 months (Part I); 1 month (Part II)
3
Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 bone marrow toxicities
Timeframe: 7 months (Part I); 1 month (Part II)
4
Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 cardiac toxicities
Timeframe: 7 months (Part I); 1 month (Part II)
5
Part I: Change from baseline in vital signs
Timeframe: 7 months (Part I); 1 month (Part II)
6
Part I: Change from baseline in physical and weight measurement
Timeframe: 7 months (Part I); 1 month (Part II)
7
Part I: Change from baseline in Comprehensive Metabolic Panel blood test
. Able and willing to comply with scheduled clinic visits and clinical trial procedures.
. Capable of understanding and giving signed informed consent form after full discussion of the research nature of the treatment and its risk and benefits with the investigator/ designee of the sponsor.
Exclusion criteria
. History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).
. Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).
. History of diabetes.
. Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)
. A result on coagulation tests (prothrombin time, activated partial thromboplastin time) obtained within 28 days before enrollment that indicates the presence of any clinically significant bleeding disorder (subjects being treated with antiplatelet therapy or anticoagulants could be enrolled after 7-day washout period):
. Any ongoing medical condition with significant risk of bleeding
. Evidence of any serious active infections, COVID 19, severe uncontrolled cardiac, renal, hepatic, pulmonary or other systemic disease, significant medical or psychiatric condition, known seropositivity to HIV/HBV/HCV, or clinically significant laboratory findings that would, in the investigator's judgment, make the subject inappropriate for the study.
. Administration of an investigational drug within 30 days prior to enrollment.
Timeframe: 7 months (Part I); 1 month (Part II)
8
Part I: Change from baseline in Complete blood count test
Timeframe: 7 months (Part I); 1 month (Part II)
9
Part I: Change from baseline in lipid profile.
Timeframe: 7 months (Part I); 1 month (Part II)
10
Part I: Change from baseline in thyroid test.
Timeframe: 7 months (Part I); 1 month (Part II)
11
Part I: Change from baseline in urinalysis
Timeframe: 7 months (Part I); 1 month (Part II)
12
Part I: Change from baseline in inflammation evaluation.
Timeframe: 7 months (Part I); 1 month (Part II)
13
Part I: Change from baseline in coagulation function.
Timeframe: 7 months (Part I); 1 month (Part II)
14
Part II: Baseline-adjusted area under the plasma concentration-time curve over a 24-hour period (AUC0-24) of deoxycholic acid
Timeframe: 16 days
15
Part II: Baseline-adjusted area under the curve from zero to time infinity (AUC0-inf) of deoxycholic acid
Timeframe: 16 days
16
Part II: Baseline-adjusted peak plasma concentration (Cmax) of deoxycholic acid
Timeframe: 16 days
17
Part II: Baseline-adjusted time to maximum concentration (Tmax) of deoxycholic acid
Timeframe: 16 days
18
Part II: Baseline-adjusted elimination half-life (T1/2) of deoxycholic acid
Timeframe: 16 days
19
Part II: Baseline-adjusted, dose-normalized area under the plasma concentration-time curve over a 24-hour period (AUC0-24)
Timeframe: 16 days
20
Part II: Baseline-adjusted, dose-normalized area under the curve from zero to time infinity (AUC0-inf) of deoxycholic acid
Timeframe: 16 days
21
Part II: Baseline-adjusted, dose-normalized peak plasma concentration (Cmax) of deoxycholic acid
Timeframe: 16 days
22
Part II: Baseline-adjusted, dose-normalized time to maximum concentration (Tmax) of deoxycholic acid
Timeframe: 16 days
23
Part II: Baseline-adjusted, dose-normalized elimination half-life (T1/2) of deoxycholic acid