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 range18 Years – 65 Years

SexALL

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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:
✓. 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).

What they're measuring

Part I: Incidence of all adverse events

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Incidence of all serious adverse events

Timeframe: 7 months (Part I); 1 month (Part II)

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)

Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 cardiac toxicities

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Change from baseline in vital signs

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Change from baseline in physical and weight measurement

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Change from baseline in Comprehensive Metabolic Panel blood test

Timeframe: 7 months (Part I); 1 month (Part II)

Trial details

NCT IDNCT07237425

SponsorGlonova Pharma Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-14

Contact for this trial

Helen Wang, MS

(+886) 2-2351-1190 Helen.Wang@ttopcro.com.tw

View on ClinicalTrials.gov More Lipoma trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

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:
✓. 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).

What they're measuring

Part I: Incidence of all adverse events

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Incidence of all serious adverse events

Timeframe: 7 months (Part I); 1 month (Part II)

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)

Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 cardiac toxicities

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Change from baseline in vital signs

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Change from baseline in physical and weight measurement

Timeframe: 7 months (Part I); 1 month (Part II)

Part I: Change from baseline in Comprehensive Metabolic Panel blood test

Timeframe: 7 months (Part I); 1 month (Part II)