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CompletedNCT05632926Updated Oct 21, 2026Results posted

A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1)

A Phase 2 interventional study of 40 mg CBL-514 and 60 mg CBL-514 in Cellulite, sponsored by Caliway Biopharmaceuticals Co., Ltd.. Completed at 2 sites in United States. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Caliway Biopharmaceuticals Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Oct 21, 2026Results postedStudy documents posted+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
Female
01

Study summary

The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.

Read the detailed description

This Phase 2a study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2. The Stage 1 will include a total of 12 participants enrolled in 3 sequential escalating CBL-514 dose groups.The groups will be open label and each group will enroll 4 participants.

Eligible participants will be sequentially assigned to receive 1 course of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.

02

Conditions studied

  • Cellulite

Browse trials for

03

In context

Cellulite

71 studies on the registry are indexed under Cellulite; 3 are open to participants now.

This study's enrollment of 12 is below the median of 34 across 65 interventional studies indexed under Cellulite.

Browse Cellulite studies →

Lead sponsor

Caliway Biopharmaceuticals Co., Ltd. is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Female aged 18 years to 64 years old (at Screening), inclusive.
  2. Have a > 18.5 and \< 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
  3. The participant has both sides of posterolateral thighs assessed according to the modified Hexsel CSS (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations. On assessment by the modified Hexsel CSS, the participant scores at least 4 and no greater than 8 at Screening and Day 1.

    The total score must contain:

    1. Hexsel CSS item (A) 'number of evident depressions' score of ≥ 1
    2. Hexsel CSS item (B) 'depth of depressions' score of ≥ 1
  4. Participant has a stable lifestyle (e.g., exercise, eating patterns, and smoking habit) per participant report for at least 3 months before Screening and during the study.
  5. Voluntarily signs the form and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Female participant of who is not willing to commit to an acceptable regimen with her partner from the time of Screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating.

    Note: females who are not of childbearing potential are not required to use contraception. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are (defined as aged at least 50 years old with ≥ 12 months of amenorrhea and a follicle-stimulating hormone [FSH] > 30 IU/L at Screening).

  2. Participant diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or aggregation within 14 days prior to the IP administration.
  3. Participant has (HbA1c) ≥ 9%, delayed wound healing, or any diabetic risks which, in the opinion of the Investigator (or designee) is inappropriate to participate in the study.
  4. Participant has a cardiovascular disease and abnormal findings in (ECG) at Investigator's (or designee's) discretion.
  5. Participant with active or prior history of within 5 years before Screening or being assessed for a possible malignancy. Except adequately treated basal cell carcinoma of the skin and in situ squamous cell carcinoma of the skin would be eligible as per Investigator's (or designee's) discretion.
  6. Participant with a history of (HIV)-1 infection, or participants with active HIV infection at Screening with a positive HIV antigen/antibody (Ag/Ab) combination test.
  7. Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experience vasovagal syncope and pass out at the sight of blood or a needle.
  8. Participant with any hepatic medical condition that, in the opinion of the Investigator (or designee), would interfere with assessment of safety or efficacy or compromise the participant's ability to undergo study procedures or provide .
  9. Participant who has a recent history of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication within 6 months prior to Screening.
  10. Participant has abnormal skin or local skin conditions at the treatment area, which in the opinion of the Investigator (or designee), is inappropriate to participate in the study. This includes but is not limited to any of the following:

    1. skin manifestations of a systemic disease
    2. any abnormality of the skin or soft tissues on the anticipated treatment area
    3. skin laxity on treatment area when the participant is in the standing position
    4. sensory loss or dysesthesia in the area to be treated
    5. evidence of any cause of enlargement in the area to be treated other than localized subcutaneous fat
    6. tattoos on the area to be treated
    7. participant with a propensity for keloid or hypertrophic scarring.
  11. Participant who has had the following surgical or aesthetic procedures:

    1. liposuction, cryolipolysis, ultrasonic lipolysis, low level laser therapy (LLLT), or lipolysis injection to the region to be treated before Screening
    2. medical device, injection (including but not limited to collagenase clostridium histolyticum injections and collagen stimulating injections), over-the-counter (OTC) cosmetic cream, or cosmetic program to prevent or mitigate EFP to the region to be treated within 12 months before Screening and throughout study participation
    3. massage to the region to be treated within 2 weeks before Screening and throughout study participation.
  12. Participant is undergoing chronic or therapy, except for asthma inhaler or topical steroids for skin conditions if the medications are not used on the treatment area.
  13. Participating is requiring continual use of the following therapeutic agents during the study: terfenadine, buspirone, fexofenadine, any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, which in the opinion of the Investigator (or designee), may affect the evaluation of the product or place the participant at undue risk.

    If a participant needs to use the above-mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used at least for 2 days before dosing and until 1 day after dosing.

  14. Participant receives nonsteroidal anti-inflammatory drug (NSAID) including aspirin within 14 days prior to the IP administration.
  15. Participant is unable to receive topical anesthesia (e.g., history of to lidocaine).
  16. Participant with known allergies or sensitivities to the IP or its components.
  17. Participant with liver cirrhosis or with inadequate liver function at Screening defined as (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALKP), total (TBIL), or gamma-glutamyl transferase (GGT) > 3.0 × (ULN).
  18. Participant with any renal impairment, defined as abnormal serum creatinine, and urea > 1.5 × ULN or estimated (eGFR) \< 90 mL/min/1.73 m2. Participants who are currently on dialysis should be excluded.

    Participants with an eGFR ≥ 60 and \< 90 mL/min/1.73 m2 at Screening should be evaluated by the Investigator to exclude pre-existing renal disease or associated dysfunction. If mild decrease in eGFR is assessed by the Investigator as not clinically significant or not related to dysfunction, the participants may be eligible upon the Investigator's assessment.

  19. Use of other investigational product or device within 4 weeks prior to Screening.
Terms in these criteria, in plain language(19)

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.

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.

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.

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.

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.

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).

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.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

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.

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.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    CBL-514 40mg

    Drug: 40 mg CBL-514

  • Experimental
    CBL-514 60mg

    Drug: 60 mg CBL-514

  • Experimental
    CBL-514 80mg

    Drug: 80 mg CBL-514

Interventions

  • Drug40 mg CBL-514

    CBL-514 will be administered at the raised area of cellulite.

  • Drug60 mg CBL-514

    CBL-514 will be administered at the raised area of cellulite.

  • Drug80 mg CBL-514

    CBL-514 will be administered at the raised area of cellulite.

06

What researchers measure

Primary outcomes

  1. Evaluation of the Improvement of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of 1 Course of CBL-514.

    Change in total scores from baseline according to the modified Hexsel cellulite severity scale (CSS) at Week 2 and Week 4 based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations. (A) Number of evident depressions: '0' = None/no depressions '1' = 1 to 4 depressions are visible '2' = 5 to 9 depressions are visible '3' = 10 or more depressions are visible (B) Depth of depressions: '0' = No depressions '1' = Superficial depressions '2' = Medium depth depressions '3' = Deep depressions (C) Morphological appearance of skin surface alterations: '0' = No raised areas '1' = 'Orange peel' appearance '2' = 'Cottage cheese' appearance '3' = 'Mattress' appearance The total score of (A), (B) and (C) will determine the cellulite severity level as follows : 0 = None 1-3 = Mild 4-6 = Moderate 7-9 = Severe

    Time frame: From baseline to Week 4

Secondary outcomes

  1. Percentage of Participants' Thighs That Achieve at Least 1-level Severity Improvement From Baseline Following Administration of 1 Course of CBL-514

    Percentage of participants' thighs that achieve at least 1-level severity improvement determined by the total scores of modified Hexsel CSS at Week 2 and Week 4 compared to baseline.

    Time frame: From baseline to Week 4

Other outcomes

  1. Number of Participants With TEAEs Following Administration of 1 Course of CBL-514.

    Number of participants with TEAEs following administration of 1 course of CBL-514.

    Time frame: from Day 1 up to Week 4

  2. Number of TEAEs Following Administration of 1 Course of CBL-514

    Number of TEAEs following administration of 1 course of CBL-514

    Time frame: From Day 1 up to Week 4

  3. Number of Participants With Adverse Events of Special Interest

    Number of participants with adverse events of special interest

    Time frame: From Day 1 up to Week 4

  4. Number of Participants With Clinically Significant Abnormalities in Laboratory Tests

    Laboratory tests include assessment of hematology, biochemistry, coagulation, and urinalysis tests

    Time frame: From Day 1 up to Week 4

  5. Number of Participants With Clinically Significant Abnormalities in Physical Examination

    Physical examinations include assessment of 12-lead electrocardiogram parameters and vital signs

    Time frame: From Day 1 up to Week 4

  6. Number of Participants Who Used Concomitant Medications to Treat Treatment-emergent Adverse Events

    Number of participants who used concomitant medications to treat treatment-emergent adverse events

    Time frame: From Day 1 up to Week 4

07

Results

Posted Oct 21, 2026

Participant flow

All 12 participants enrolled in the study received a single treatment of CBL-514 in 3 sequential escalating doses on the postlateral thighs (administered as multiple subcutaneous injections) on Day 1 only.

Participant flow — Overall Study
MilestoneCBL-514 40mgCBL-514 60mgCBL-514 80mg
Started444
Completed434
Not completed010
Withdrew: Protocol violation010

Outcome measures

PrimaryEvaluation of the Improvement of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of 1 Course of CBL-514.

Change in total scores from baseline according to the modified Hexsel cellulite severity scale (CSS) at Week 2 and Week 4 based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations. (A) Number of evident depressions: '0' = None/no depressions '1' = 1 to 4 depressions are visible '2' = 5 to 9 depressions are visible '3' = 10 or more depressions are visible (B) Depth of depressions: '0' = No depressions '1' = Superficial depressions '2' = Medium depth depressions '3' = Deep depressions (C) Morphological appearance of skin surface alterations: '0' = No raised areas '1' = 'Orange peel' appearance '2' = 'Cottage cheese' appearance '3' = 'Mattress' appearance The total score of (A), (B) and (C) will determine the cellulite severity level as follows : 0 = None 1-3 = Mild 4-6 = Moderate 7-9 = Severe

Time frame:
From baseline to Week 4
Reported as:
Mean · score on a scale
Evaluation of the Improvement of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of 1 Course of CBL-514.
score on a scaleCBL-514 40mgCBL-514 60mgCBL-514 80mg
Baseline6.8 ± 1.36.1 ± 1.67.8 ± 0.7
Week 24.6 ± 0.74.9 ± 1.85.8 ± 0.5
Week 44.8 ± 0.74.6 ± 1.85.1 ± 1.1
Change at Week 2 from Baseline-2.1 ± 1.0-1.3 ± 0.9-2.0 ± 0.9
Change at Week 4 from Baseline-2.0 ± 0.9-1.5 ± 0.9-2.6 ± 1.5
SecondaryPercentage of Participants' Thighs That Achieve at Least 1-level Severity Improvement From Baseline Following Administration of 1 Course of CBL-514

Percentage of participants' thighs that achieve at least 1-level severity improvement determined by the total scores of modified Hexsel CSS at Week 2 and Week 4 compared to baseline.

Time frame:
From baseline to Week 4
Reported as:
Count of units · thigh
Percentage of Participants' Thighs That Achieve at Least 1-level Severity Improvement From Baseline Following Administration of 1 Course of CBL-514
thighCBL-514 40mgCBL-514 60mgCBL-514 80mg
Week 2557
Week 4577
Other pre-specifiedNumber of Participants With TEAEs Following Administration of 1 Course of CBL-514.

Number of participants with TEAEs following administration of 1 course of CBL-514.

Time frame:
from Day 1 up to Week 4
Reported as:
Count of participants · Participants
Number of Participants With TEAEs Following Administration of 1 Course of CBL-514.
ParticipantsCBL-514 40mgCBL-514 60mgCBL-514 80mg
Mild232
Moderate100
Other pre-specifiedNumber of TEAEs Following Administration of 1 Course of CBL-514

Number of TEAEs following administration of 1 course of CBL-514

Time frame:
From Day 1 up to Week 4
Reported as:
Count of units · event
Number of TEAEs Following Administration of 1 Course of CBL-514
eventCBL-514 40mgCBL-514 60mgCBL-514 80mg
Mild182221
Moderate200
Other pre-specifiedNumber of Participants With Adverse Events of Special Interest

Number of participants with adverse events of special interest

Time frame:
From Day 1 up to Week 4
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest
ParticipantsCBL-514 40mgCBL-514 60mgCBL-514 80mg
Number of Participants With Adverse Events of Special Interest000
Other pre-specifiedNumber of Participants With Clinically Significant Abnormalities in Laboratory Tests

Laboratory tests include assessment of hematology, biochemistry, coagulation, and urinalysis tests

Time frame:
From Day 1 up to Week 4
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
ParticipantsCBL-514 40mgCBL-514 60mgCBL-514 80mg
Hematology000
Biochemistry000
Coagulation000
Urinalysis tests000
Other pre-specifiedNumber of Participants With Clinically Significant Abnormalities in Physical Examination

Physical examinations include assessment of 12-lead electrocardiogram parameters and vital signs

Time frame:
From Day 1 up to Week 4
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examination
ParticipantsCBL-514 40mgCBL-514 60mgCBL-514 80mg
12-lead Electrocardiogram000
Vital signs000
Other pre-specifiedNumber of Participants Who Used Concomitant Medications to Treat Treatment-emergent Adverse Events

Number of participants who used concomitant medications to treat treatment-emergent adverse events

Time frame:
From Day 1 up to Week 4
Reported as:
Count of participants · Participants
Number of Participants Who Used Concomitant Medications to Treat Treatment-emergent Adverse Events
ParticipantsCBL-514 40mgCBL-514 60mgCBL-514 80mg
Number of Participants Who Used Concomitant Medications to Treat Treatment-emergent Adverse Events111

Adverse events

Collected over from baseline until the end of follow-up, up to 4 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CBL-514 40mg0/4 (0%)0/4 (0%)3/4 (75%)
CBL-514 60mg0/4 (0%)0/4 (0%)3/4 (75%)
CBL-514 80mg0/4 (0%)0/4 (0%)2/4 (50%)
Most frequent other events
Most frequent other events
EventCBL-514 40mgCBL-514 60mgCBL-514 80mg
Injection site bruisingGeneral disorders2/43/41/4
Injection site erythemaGeneral disorders2/42/41/4
Injection site swellingGeneral disorders2/42/41/4
Injection site painGeneral disorders0/42/42/4
Injection site pruritusGeneral disorders2/41/41/4
Injection site warmthGeneral disorders1/41/42/4
Injection site indurationGeneral disorders0/41/41/4
Injection site discolourationGeneral disorders1/40/40/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
Mean51.5 ± 11.249 ± 8.951.3 ± 16.650.6 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
Female44412
Male0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American1102
White33410
More than one race0000
Unknown or Not Reported0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
Hispanic or Latino1001
Not Hispanic or Latino34411
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
United States44412
Childbearing potential
Childbearing potential(Participants)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
Yes2327
No2125
Weight
Weight(kilograms)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
Mean73.10 ± 2.4473.45 ± 11.9366.03 ± 9.0970.86 ± 8.70
Height
Height(centimeters)CBL-514 40mgCBL-514 60mgCBL-514 80mgTotal
Mean160.00 ± 4.64167.03 ± 9.45159.35 ± 3.83162.13 ± 6.89

1 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Investigational Site 1
    Encino, California 91436, United States
  • Investigational Site 2
    New York, New York 10022, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Oct 21, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedEvaluation of the improvementImprovement of edematous fibrosclerotic panniculopathyEdematous Fibrosclerotic Panniculopathy (EFP) measuredMeasured by cellulite severity scale from baseline following administrationCellulite Severity Scale From Baseline Following Administration of 1 courseCourse of CBL-514.Time frame: Up to 4 weeks from treatment visit → From baseline to Week 4
Oct 21, 2026
Documents
Secondary outcomes
5 edited, 2 added, 3 removed
What changed in the outcomes
  • EditedPercentage of participantsParticipants' thighs that achieveThighs That Achieve at leastLeast 1-level severity improvement measured by cellulite severity scale from baseline following administrationSeverity Improvement From Baseline Following Administration of 1 courseCourse of CBL-514.Time frame: Up to 4 weeks from treatment visit → From baseline to Week 4
  • Editedother outcomeIncidenceNumber of adverse eventsParticipants With Adverse Events of special interestSpecial InterestTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
  • Editedother outcomeNumber of participants with clinically significant abnormalitiesParticipants With Clinically Significant Abnormalities in laboratory testsLaboratory TestsTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
  • Editedother outcomeNumber of participants with clinically significant abnormalitiesParticipants With Clinically Significant Abnormalities in physical examinationPhysical ExaminationTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
  • Editedother outcomeIncidenceNumber of use of concomitant medicationsParticipants Who Used Concomitant Medications to treat treatmentTreat Treatment-emergent adverse events (TEAEs)Adverse EventsTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
  • Addedother outcomeNumber of Participants With TEAEs Following Administration of 1 Course of CBL-514.Time frame: from Day 1 up to Week 4
  • Addedother outcomeNumber of TEAEs Following Administration of 1 Course of CBL-514Time frame: From Day 1 up to Week 4
  • Removedother outcomeIncidence of adverse events and treatment-emergent adverse events (TEAEs)Time frame: 4 weeks from treatment visit
  • Removedother outcomeIncidence of adverse events and treatment-emergent adverse events (TEAEs) at the injection site(s)Time frame: 4 weeks from treatment visit
  • Removedother outcomeIncidence of adverse events and treatment-emergent adverse events (TEAEs) related to the investigational product (IP)Time frame: 4 weeks from treatment visit
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Results posted
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedEvaluation of the improvementImprovement of edematous fibrosclerotic panniculopathyEdematous Fibrosclerotic Panniculopathy (EFP) measuredMeasured by cellulite severity scale from baseline following administrationCellulite Severity Scale From Baseline Following Administration of 1 courseCourse of CBL-514.Time frame: Up to 4 weeks from treatment visit → From baseline to Week 4
    Secondary outcomes 5 edited, 2 added, 3 removed
    What changed in the outcomes
    • EditedPercentage of participantsParticipants' thighs that achieveThighs That Achieve at leastLeast 1-level severity improvement measured by cellulite severity scale from baseline following administrationSeverity Improvement From Baseline Following Administration of 1 courseCourse of CBL-514.Time frame: Up to 4 weeks from treatment visit → From baseline to Week 4
    • Editedother outcomeIncidenceNumber of adverse eventsParticipants With Adverse Events of special interestSpecial InterestTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
    • Editedother outcomeNumber of participants with clinically significant abnormalitiesParticipants With Clinically Significant Abnormalities in laboratory testsLaboratory TestsTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
    • Editedother outcomeNumber of participants with clinically significant abnormalitiesParticipants With Clinically Significant Abnormalities in physical examinationPhysical ExaminationTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
    • Editedother outcomeIncidenceNumber of use of concomitant medicationsParticipants Who Used Concomitant Medications to treat treatmentTreat Treatment-emergent adverse events (TEAEs)Adverse EventsTime frame: 4 weeks from treatment visit → From Day 1 up to Week 4
    • Addedother outcomeNumber of Participants With TEAEs Following Administration of 1 Course of CBL-514.Time frame: from Day 1 up to Week 4
    • Addedother outcomeNumber of TEAEs Following Administration of 1 Course of CBL-514Time frame: From Day 1 up to Week 4
    • Removedother outcomeIncidence of adverse events and treatment-emergent adverse events (TEAEs)Time frame: 4 weeks from treatment visit
    • Removedother outcomeIncidence of adverse events and treatment-emergent adverse events (TEAEs) at the injection site(s)Time frame: 4 weeks from treatment visit
    • Removedother outcomeIncidence of adverse events and treatment-emergent adverse events (TEAEs) related to the investigational product (IP)Time frame: 4 weeks from treatment visit
    + 2 other changes: verification date and index terms

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 ↗

11

Registry details

Key details

Study ID
NCT05632926
Responsible party
Sponsor
First posted
Dec 1, 2022
Start date
Jan 9, 2023
Primary completion
May 3, 2023
Completion
May 3, 2023
Results posted
Oct 21, 2026
Last update
Oct 21, 2026

Study contacts

Anne Sheu
study director · Caliway Biopharmaceuticals Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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