AzTrials
AzTrials

LipomaPhase 1NCT07237425

Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

A Phase 1 study testing Ronkyla Plus and Kybella in people with Lipoma and Submental Fullness, run by Glonova Pharma Co., Ltd at 3 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Lipoma, Submental Fullness
What is being tested?
Ronkyla Plus and Kybella
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
3 sitesTaiwan
Study dates
14 Nov 2025to 31 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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)
  • Tubal ligation
  • Vasectomized male partner
  • Sexual abstinence
  • Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.
  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.
  • Serum creatinine > 1.5 X ULN.
  • Hemoglobin < lower limit of normal (LLN).
  • Platelets ≤ 100.000/mm³.
  • Current malignancy of any organ system or a history within 5 years.
  • Subjects who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.
  • Part I \& Part II Ronkyla Plus cohort specific exclusion criteria:
  • History of any medical condition contraindicated or not recommended for aspirin use including active peptic ulcer disease, asthma, gout, uncontrolled hypertension.
  • Taking any medication contraindicated or not recommended for concomitant use with aspirin within 7 days prior to enrollment.
  • Allergic to Aspirin, salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).
  • The target lipoma warrants surgical removal per the investigator's judgement (e.g., for confirming its pathology).
  • Part I dose level 2 and 4 cohorts \& Part II specific exclusion criteria:
  • History of alcohol or drug abuse within the past year prior to Day 1.
  • History of smoking or use of nicotine-containing product within 6 months prior to Day 1.
  • Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cindy Chen, MS contact

(+886) 2-2351-1190 ext. 233

Cindy.Chen@glonova.com.tw

Taiwan3 sites, 3 recruiting

  • Cathay General Hospital Sijhih Branch

    New Taipei City, Sijhih District, 22174

    Yu-Hsiu Yen, MD, +886-2-27082121 ext. 5591-93, yenyuhsiu@gmail.com

    Recruiting

  • Cathay General Hospital

    Taipei, Da'an District, 106436

    Yu-Hsiu Yen, MD, +886-2-27082121 ext. 5591-93, yenyuhsiu@gmail.com

    Chi-Ming Pu, MD

    Recruiting

  • Taipei Medical University Hospital

    Taipei, Xinyi District, 110301

    Ming-Hsiu Lin, MD, Ph.D., +886 2737181 ext. 8215, minghsiu@tmu.edu.tw

    Ming-Hsiu Lin, MD, Ph.D.

    Recruiting

Other trials in Taiwan

About this study

Official title: A Safety, Efficacy and Pharmacokinetic Evaluation Study of Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

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.

Read the detailed description

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.

Being tested
Ronkyla Plus, Placebo, Kybella
Keywords
ATX-101, Ronkyla Plus
Medical subject headings
Lipoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ronkyla PlusDrug

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

  • PlaceboDrug

    Also called Normal saline

    Normal saline for injection.

  • KybellaDrug

    Also called deoxycholic acid, ATX-101

    10 mg/mL deoxycholic acid injection

Study groups in NCT07237425
Study groupRoleWhat they receive
Part I: Dose Level 1Experimental0.25 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.
Receives: Drug: Ronkyla Plus; Drug: Placebo
Part I: Dose Level 2Experimental0.5 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.
Receives: Drug: Ronkyla Plus; Drug: Placebo
Part I: Dose Level 3Experimental0.75 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.
Receives: Drug: Ronkyla Plus; Drug: Placebo
Part I: Dose Level 4Experimental1.0 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.
Receives: Drug: Ronkyla Plus; Drug: Placebo
Part II: Ronkyla Plus treatmentExperimentalEligible 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.
Receives: Drug: Ronkyla Plus
Part II: Kybella treatmentActive comparatorEligible 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.
Receives: Drug: Kybella

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part I: Incidence of all adverse events

    Also a Part II Secondary Outcome Measure

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

  2. Part I: Incidence of all serious adverse events

    Also a Part II Secondary Outcome Measure

    Measured: 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

    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)

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

  4. 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)

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

  5. 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)

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

  6. 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.

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

  7. 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

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

  8. 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

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

  9. 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.

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

  10. Part I: Change from baseline in thyroid test.

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

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

  11. 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.

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

  12. Part I: Change from baseline in inflammation evaluation.

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

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

  13. Part I: Change from baseline in coagulation function.

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

    Measured: 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

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

    Measured: 16 days

  15. 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)

    Measured: 16 days

  16. 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)

    Measured: 16 days

  17. 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)

    Measured: 16 days

  18. 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)

    Measured: 16 days

  19. 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

    Measured: 16 days

  20. 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

    Measured: 16 days

  21. 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

    Measured: 16 days

  22. 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.

    Measured: 16 days

  23. 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

    Measured: 16 days

Secondary outcomes (10)

  1. 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

    Measured: 2 months

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. 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).

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

    Measured: 25 weeks (Part I); 1 week (Part II)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start14 Nov 2025
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237425
Sponsor's protocol ID
SDC003
Status last verified
Sep 2026
First submitted
13 Nov 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ronkyla Plus and Kybella in people with Lipoma and Submental Fullness, run by Glonova Pharma Co., Ltd at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cindy Chen, MS ((+886) 2-2351-1190 ext. 233, Cindy.Chen@glonova.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: Incidence of all adverse events (time frame: 7 months (Part I); 1 month (Part II)). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07237425.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in