A Phase 1 interventional study of Ronkyla Plus and Placebo in Lipoma and Submental Fullness, sponsored by Glonova Pharma Co., Ltd. Recruiting at 3 sites in Taiwan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Glonova Pharma Co., Ltd · Phase 1, Interventional, and Treatment
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.
Part I is a randomized, double-blind, placebo-controlled, and sequential dose-escalation study. Eligible subjects will receive intralesional injections of Ronkyla Plus or placebo at a volume dependent on the size of their superficial lipoma, up to a maximum of 10 mL per treatment, at 28-day intervals for up to a maximum of 6 treatments. In the first treatment cycle, subjects will stay in hospital for 3 hours after treatment for evaluation of acute safety profile. Subjects will return to the hospital on Day 8 and Day 29 of each treatment cycle for safety profile evaluation.
Part II is an open-label, single-dose, 2-treatment, parallel study to evaluate the relative bioavailability of Ronkyla Plus injection in comparison with that of Kybella injection. Eligible, non-smoking males and females aged 18 to 65 with treatable superficial lipoma or submental fullness will be included in the study. Twenty (20) subjects for each target symptom, in a total of 40 subjects, are planned to be enrolled in the study to achieve at least 16 evaluable subjects in each treatment group. After screening, subjects will be assigned to Ronkyla Plus or Kybella treatment based on their symptoms and undergo a 16-day PK assessment.
For Ronkyla Plus injection, subject will receive a single intralesional treatment at the maximum tolerated dose (MTD) as determined in Part I. For Kybella injection, subject will receive the maximum dose approved for a single treatment (100 mg) in the submental area.
In the PK assessment period, subjects will visit the hospital in the mornings of Day 3 (48.0 h), Day 5 (96.0 h), Day 8 (168.0 h), Day 11 (240.0 h), and Day 15 (336.0 h), and two consecutive 24-hr PK blood samplings from Day -2 evening to Day 2 morning (pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0 h post-dose on Day 1\~Day 2; same blood sampling time on Day -1\~Day 1 without dosing). Two weeks after the end of the 16-day PK assessment period, subjects of Ronkyla Plus cohort will be eligible for up to 5 additional treatments of Ronkyla Plus for complete clearance of their target superficial lipomas, whereas subjects of Kybella cohort will be eligible for up to 5 additional treatments of Ronkyla (10.56 mg/mL SDC injection approved in Taiwan for submental fullness treatment, pharmaceutical equivalent of Kybella) for improvement of their submental fullness.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's planned enrollment of 56 is above the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →This is the only study on the registry with Glonova Pharma Co., Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
OR, sufficient submental fat for injection of 100 mg Kybella in the judgment of the investigator (Part II Kybella cohort only)
Females of must have a negative human chorionic gonadotropin (hCG) test result within 28 days before enrollment and agree to use a highly effective method of from enrollment up to the study end, such as:
Female subject being for at least 1 year or surgically sterile is considered to be of no childbearing potential.
Exclusion Criteria:
A result on coagulation tests (, activated partial thromboplastin time) obtained within 28 days before enrollment that indicates the presence of any bleeding disorder (subjects being treated with antiplatelet therapy or anticoagulants could be enrolled after 7-day ):
Abnormal hepatic and renal functions; hematologic changes at screening:
Part I \& Part II Ronkyla Plus cohort specific exclusion criteria:
Part I dose level 2 and 4 cohorts \& Part II specific exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.
Normal saline for injection.
Also known as: Normal saline
10 mg/mL deoxycholic acid injection
Also known as: deoxycholic acid, ATX-101
Part I: Incidence of all adverse events
Also a Part II Secondary Outcome Measure
Time frame: 7 months (Part I); 1 month (Part II)
Part I: Incidence of all serious adverse events
Also a Part II Secondary Outcome Measure
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 16 days
Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of Cycle 2 (Part I only)
At screening, 1 target superficial lipoma will be selected for treatment. Lipoma will be measured in ≥ 2 dimensions (longest length, perpendicular width, and height if possible) using both digital calipers and ultrasound imaging. Almost complete clearance is defined as ≥ 90% reduction in surface area of the target superficial lipoma
Time frame: 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
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
Time frame: 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
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
Time frame: 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
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
Time frame: 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
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
Time frame: 7 months (Part I); 1 month (Part II)
Percentage of subjects having their target superficial lipoma rated by the investigator as 0 or 1 point on the investigator's lipoma morphology assessment scale at the end of each treatment cycle and end of study
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort. At screening, the beginning/end of each treatment cycle, and the end of study, the investigator will use a 4-point scale of 0-3 to rate the morphology of subjects' target lipomas where 0= Not palpable, 1=Not visible, barely palpable, 2=Visible upon palpation, and 3=Clearly visible, easily palpable. A score of 0 to 1 indicates favorable morphological changes of the target lipoma following treatment(s).
Time frame: 7 months (Part I); 1 month (Part II)
Percentage of subjects having their target superficial lipoma rated by the investigator with ≥2 points improvement on the investigator's lipoma morphology assessment scale at the end of each treatment cycle and end of study
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort. Investigator's lipoma morphology assessment scale where 0 = not palpable; 1 = not visible, barely palpable; 2 = visible upon palpation; 3 = clearly visible, easily palpable. The percentage of subjects having their target superficial lipomas assessed by the investigator on the scale as follows: 0 or 1 point; with ≥ 2 points improvement from baseline; with ≥ 1 point improvement from baseline.
Time frame: 7 months (Part I); 1 month (Part II)
Percentage of subjects having their target superficial lipoma rated by the investigator with ≥1 point improvement on the investigator's lipoma morphology assessment scale at the end of each treatment cycle and end of study
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort. Investigator's lipoma morphology assessment scale where 0 = not palpable; 1 = not visible, barely palpable; 2 = visible upon palpation; 3 = clearly visible, easily palpable. The percentage of subjects having their target superficial lipomas assessed by the investigator on the scale as follows: 0 or 1 point; with ≥ 2 points improvement from baseline; with ≥ 1 point improvement from baseline.
Time frame: 7 months (Part I); 1 month (Part II)
Percentage of subjects being satisfied with treatment outcome at the end of each treatment cycle and end of study
Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort. Satisfaction assessment will be performed independently by subjects using a 5-point scale where 0 = worsen, 1 = no response, 2 = moderate response, 3 = good response, and 4 = excellent response. A score of 3 or 4 qualifies for a satisfactory treatment outcome.
Time frame: 7 months (Part I); 1 month (Part II)
Injection site pain rated by subjects on a 0-10 numeric rating scale (NRS) at 1 hour and 1 week after each treatment
Days 1, 8, 29, 36, 57, 64, 85, 92, 113, 120, 141, 148 for Part I; Days 1, 8 for Part II Ronkyla Plus cohort. At approximately 1 hour after each treatment, and at the 1-week follow-up visit for each treatment, subjects will be asked to rate their injection site pain using a 0-10 numeric rating scale (NRS) where 0 = no pain and 10 = most severe pain possible.
Time frame: 25 weeks (Part I); 1 week (Part II)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for May 2028, 30 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.