Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

NCT07237425 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SDC003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

ATX-101; Ronkyla Plus

Outcome Measures

Primary Outcomes (23)

• Part I: Incidence of all adverse events

  Also a Part II Secondary Outcome Measure

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

• Part I: Incidence of all serious adverse events

  Also a Part II Secondary Outcome Measure

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

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

  Also a Part II Secondary Outcome Measure. CTCAE version 5.0 (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)

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

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

  Also a Part II Secondary Outcome Measure. CTCAE version 5.0 (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)

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

• Part I: Change from baseline in vital signs

  Also a Part II Secondary Outcome Measure. Measurement of blood pressure (including systolic blood pressure and diastolic blood pressure, unit: mmHg; pulse rate, unit: beats/mins; respiratory rate, unit: times/min; body temperature, unit: degree Celsius)

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

• Part I: Change from baseline in physical and weight measurement

  Also a Part II Secondary Outcome Measure. Physical examination includes: general appearance and weight (kg), HEENT (head, eyes, ears, nose, and throat), mouth, skin, neck (including thyroid), lymph nodes, spine, cardiovascular system, gastrointestinal system, nervous system, musculoskeletal system, mental status.

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

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

  Also a Part II Secondary Outcome Measure. Blood test for: albumin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, total bilirubin and protein, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase

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

• Part I: Change from baseline in Complete blood count test

  Also a Part II Secondary Outcome Measure. Blood test includes: hemoglobin, hematocrit, red blood cell, white blood cell (neutrophils, band %, segment %, eosinophils, basophils, lymphocytes, and monocytes), platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin

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

• Part I: Change from baseline in lipid profile.

  Also a Part II Secondary Outcome Measure. Blood test includes: total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride.

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

• Part I: Change from baseline in thyroid test.

  Also a Part II Secondary Outcome Measure. Blood test includes: triidothyronine, thyroxine, and thyroid-stimulating hormone.

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

• Part I: Change from baseline in urinalysis

  Also a Part II Secondary Outcome Measure. Measurement includes: pH, protein, occult blood, leukocyte, glucose, ketones, bilirubin, urobilinogen, nitrite, clinical microscopy.

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

• Part I: Change from baseline in inflammation evaluation.

  Also a Part II Secondary Outcome Measure. Test includes: c-reactive protein, erythrocyte sedimentation rate

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

• Part I: Change from baseline in coagulation function.

  Also a Part II Secondary Outcome Measure. Blood test includes: prothrombin time, activated partial thromboplastin time

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

• Part II: Baseline-adjusted area under the plasma concentration-time curve over a 24-hour period (AUC0-24) of deoxycholic acid

  PK values on Day -1\~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 \~Day 15 (post-dosing)

  16 days

• Part II: Baseline-adjusted area under the curve from zero to time infinity (AUC0-inf) of deoxycholic acid

  PK values on Day -1\~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 \~Day 15 (post-dosing)

  16 days

• Part II: Baseline-adjusted peak plasma concentration (Cmax) of deoxycholic acid

  PK values on Day -1\~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 \~Day 15 (post-dosing)

  16 days

• Part II: Baseline-adjusted time to maximum concentration (Tmax) of deoxycholic acid

  PK values on Day -1\~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 \~Day 15 (post-dosing)

  16 days

• Part II: Baseline-adjusted elimination half-life (T1/2) of deoxycholic acid

  PK values on Day -1\~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 \~Day 15 (post-dosing)

  16 days

• Part II: Baseline-adjusted, dose-normalized area under the plasma concentration-time curve over a 24-hour period (AUC0-24)

  Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid

  16 days

• Part II: Baseline-adjusted, dose-normalized area under the curve from zero to time infinity (AUC0-inf) of deoxycholic acid

  Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid

  16 days

• Part II: Baseline-adjusted, dose-normalized peak plasma concentration (Cmax) of deoxycholic acid

  Baseline-adjusted PK values will be divided by injected dose of deoxycholic acid

  16 days

• Part II: Baseline-adjusted, dose-normalized time to maximum concentration (Tmax) of deoxycholic acid

  Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid.

  16 days

• Part II: Baseline-adjusted, dose-normalized elimination half-life (T1/2) of deoxycholic acid

  Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid

  16 days

Secondary Outcomes (10)

• Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of Cycle 2 (Part I only)

  2 months

• Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study

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

• Percentage of subjects with "complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study

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

• Percentage of subjects with "almost complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study

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

• Percentage reduction in size of the target superficial lipoma at the end of each treatment cycle and end of study

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

Study Arms (6)

Part I: Dose Level 1

EXPERIMENTAL

0.25 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.

Drug: Ronkyla Plus; Drug: Placebo

Part I: Dose Level 2

EXPERIMENTAL

0.5 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.

Drug: Ronkyla Plus; Drug: Placebo

Part I: Dose Level 3

EXPERIMENTAL

0.75 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.

Drug: Ronkyla Plus; Drug: Placebo

Part I: Dose Level 4

EXPERIMENTAL

1.0 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.

Drug: Ronkyla Plus; Drug: Placebo

Part II: Ronkyla Plus treatment

EXPERIMENTAL

Eligible subjects with a treatable superficial lipoma will receive a single treatment of Ronkyla Plus at the maximum tolerated dose determined in Part I and undergo a 16-day PK assessment.

Drug: Ronkyla Plus

Part II: Kybella treatment

ACTIVE COMPARATOR

Eligible subjects with submental fullness will receive a single treatment of Kybella at the maximum approved dose for a single session (100 mg) and undergo a 16-day PK assessment.

Drug: Kybella

Interventions

Ronkyla Plus DRUG

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

Part I: Dose Level 1; Part I: Dose Level 2; Part I: Dose Level 3; Part I: Dose Level 4; Part II: Ronkyla Plus treatment

Placebo DRUG

Normal saline for injection.

Also known as: Normal saline

Part I: Dose Level 1; Part I: Dose Level 2; Part I: Dose Level 3; Part I: Dose Level 4

Kybella DRUG

10 mg/mL deoxycholic acid injection

Also known as: deoxycholic acid, ATX-101

Part II: Kybella treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• History of slow growth followed by dormancy, and stable for at least 6 months.
• Greatest length by greatest perpendicular width between 1 and 10 square centimeters, inclusive.
• Discrete, oval to rounded in shape, not hard or attached to underlying tissue.
• Located on the trunk, arms, legs, or neck
• Needle biopsy core tissue sample histological analysis results consistent with a diagnosis of lipoma.
• OR, sufficient submental fat for injection of 100 mg Kybella in the judgment of the investigator (Part II Kybella cohort only)
• 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:
• Intrauterine device
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation (oral, intravaginal, or transdermal)
• Progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, injectable, intrauterine, or implantable)

You may not qualify if:

• 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):
• Prothrombin time \> 20 seconds.
• Activated partial thromboplastin time \> 60 seconds.
• INR \> 3.
• 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.
• Administration of a COVID-19 vaccine within 30 days prior to enrollment.
• Abnormal hepatic and renal functions; hematologic changes at screening:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 X upper limit of normal (ULN).
• Total bilirubin \> 1.5 X ULN.

Sponsors & Collaborators

• Glonova Pharma Co., Ltd: lead
• T-TOP Clinical Research Co., Ltd.: collaborator

Study Sites (2)

Cathay General Hospital

Taipei, Da'an District, 106436, Taiwan

RECRUITING

Cathay General Hospital Sijhih Branch

New Taipei City, Sijhih District, 22174, Taiwan

RECRUITING

MeSH Terms

Conditions

Lipoma

Interventions

Saline Solution; Deoxycholic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Yu-Hsiu Yen, MD

  Cathay General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Wang, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Part I study will be conducted under double-blind conditions. All subjects, investigators and most of the study site staff will be blinded to the treatment assignment either at the time of randomization or later throughout the conduct of the study. In the meantime, the designated site staff responsible for IMP preparation and the designated CRO's data analysis team responsible for generating the randomization code list will be the only individuals unblinded to the treatment assignment. The Part II study will be conducted under open-label conditions.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ronkyla Plus will be studied in four dose-escalating cohorts in Part I, with each subsequent cohort initiated only after a favorable safety profile has been observed in the first treatment cycle of the preceding cohort and the sponsor and the investigator determine that the trial can proceed. Part II will utilize a parallel study model where subjects with superficial lipoma(s) or submental fullness will be assigned to Ronkyla Plus or Kybella treatment cohort, respectively.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): January 14, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)