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CompletedNCT05836779Updated Jul 9, 2026Results posted

A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)

A Phase 2 interventional study of CBL-514 injection in Cellulite, sponsored by Caliway Biopharmaceuticals Co., Ltd.. Completed at 5 sites in United States. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

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

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
Female
01

Study summary

The Stage 2 of this phase 2 study is an open-label, single-arm 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 2 will include a total of 20 participants enrolled in 1 selected CBL-514 dose.

Eligible participants will be sequentially assigned to receive up to 2 courses of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs.

02

Conditions studied

  • Cellulite

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03

Who can participate

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

Inclusion criteria

  1. Female aged 18 years to 64 years old (at Screening), inclusive.
  2. Have a BMI > 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 informed consent 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 childbearing potential who is not willing to commit to an acceptable contraceptive 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 postmenopausal (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 platelet aggregation within 14 days prior to the IP administration.
  3. Participant has hemoglobin A1c (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 clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG) at Investigator's (or designee's) discretion.
  5. Participant with active or prior history of malignancies 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 human immunodeficiency virus (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 informed consent.
  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 steroid or immunosuppressive 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 investigational 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 hypersensitivity 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 aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALKP), total bilirubin(TBIL), or gamma-glutamyl transferase (GGT) > 3.0 × upper limit of normal (ULN).
  18. Participant with any renal impairment, defined as abnormal serum creatinine, and urea > 1.5 × ULN or estimated glomerular filtration rate (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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    CBL-514 up to 320mg

    Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.

    Drug: CBL-514 injection

Interventions

  • DrugCBL-514 injection

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

05

What researchers measure

Primary outcomes

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

    Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.

    Time frame: From baseline to 4 weeks after the final treatment visit

Secondary outcomes

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

    Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations. 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 4 weeks after the final treatment visit

  2. Evaluation of the Total Score Change of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.

    Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 12 weeks aftre the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.

    Time frame: From baseline to 12 weeks after the final treatment visit

  3. Percentage of Participants' Thighs That Achieve at Least 2-score Improvement Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.

    Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.

    Time frame: From baseline to 4 weeks after the final treatment visit

  4. Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Clinician, Following the Administration of at Least 1 Course of CBL-514.

    The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale to assess aesthetic improvement in appearance compared to pre-treatment, as judged by the Investigator. The rating categories are 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. Improvement in GAIS is defined as "improved", "much improved", and "very much improved".

    Time frame: 4 weeks after the final treatment visit

  5. Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Participant, Following the Administration of at Least 1 Course of CBL-514.

    The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale to assess aesthetic improvement in appearance compared to pre-treatment, as judged by the participant. The rating categories are 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. Improvement in GAIS is defined as "improved", "much improved", and "very much improved".

    Time frame: 4 weeks after the final treatment visit

Other outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Number of participants with TEAEs

    Time frame: From baseline until the end of follow-up, up to 17 weeks

  2. Number of Treatment-emergent Adverse Events (TEAEs)

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

    Time frame: From baseline until the end of follow-up, up to 17 weeks

  3. Number of Participants With Adverse Events of Special Interest

    Number of participants with adverse events of special interest

    Time frame: From baseline until the end of follow-up, up to 17 weeks

  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 baseline until the end of follow-up, up to 17 weeks

06

Results

Posted Jul 9, 2026

Participant flow

Participant flow — Overall Study
MilestoneCBL-514 up to 320mg
Started23
Completed14
Not completed9

Outcome measures

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

Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.

Time frame:
From baseline to 4 weeks after the final treatment visit
Reported as:
Mean · Scores on a scale
Evaluation of the Score Change of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.
Scores on a scaleCBL-514 up to 320mg
Evaluation of the Score Change of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.-1.2 ± 1.3
Statistical analysis
  • CBL-514 up to 320mg · Paired t-test · p = <0.00001
SecondaryPercentage of Participants' Thighs That Achieve at Least 1-level Severity Improvement Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.

Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations. 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 4 weeks after the final treatment visit
Reported as:
Count of units · Thigh
Percentage of Participants' Thighs That Achieve at Least 1-level Severity Improvement Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.
ThighCBL-514 up to 320mg
Percentage of Participants' Thighs That Achieve at Least 1-level Severity Improvement Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.18
SecondaryEvaluation of the Total Score Change of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.

Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 12 weeks aftre the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.

Time frame:
From baseline to 12 weeks after the final treatment visit
Reported as:
Mean · Scores on a scale
Evaluation of the Total Score Change of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.
Scores on a scaleCBL-514 up to 320mg
Evaluation of the Total Score Change of Edematous Fibrosclerotic Panniculopathy (EFP) Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.-1.2 ± 1.2
Statistical analysis
  • CBL-514 up to 320mg · Paired t-test · p = <0.00001
SecondaryPercentage of Participants' Thighs That Achieve at Least 2-score Improvement Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.

Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.

Time frame:
From baseline to 4 weeks after the final treatment visit
Reported as:
Count of units · Thigh
Percentage of Participants' Thighs That Achieve at Least 2-score Improvement Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.
ThighCBL-514 up to 320mg
Percentage of Participants' Thighs That Achieve at Least 2-score Improvement Measured by Cellulite Severity Scale From Baseline Following Administration of at Least 1 Course of CBL-514.14
SecondaryPercentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Clinician, Following the Administration of at Least 1 Course of CBL-514.

The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale to assess aesthetic improvement in appearance compared to pre-treatment, as judged by the Investigator. The rating categories are 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. Improvement in GAIS is defined as "improved", "much improved", and "very much improved".

Time frame:
4 weeks after the final treatment visit
Reported as:
Count of units · Thigh
Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Clinician, Following the Administration of at Least 1 Course of CBL-514.
ThighCBL-514 up to 320mg
Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Clinician, Following the Administration of at Least 1 Course of CBL-514.41
SecondaryPercentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Participant, Following the Administration of at Least 1 Course of CBL-514.

The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale to assess aesthetic improvement in appearance compared to pre-treatment, as judged by the participant. The rating categories are 'worse', 'no change', 'improved', 'much improved', and 'very much improved'. Improvement in GAIS is defined as "improved", "much improved", and "very much improved".

Time frame:
4 weeks after the final treatment visit
Reported as:
Count of units · Thigh
Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Participant, Following the Administration of at Least 1 Course of CBL-514.
ThighCBL-514 up to 320mg
Percentage of Participants' Thighs With Improvement in Global Aesthetic Improvement Scale (GAIS) Reported by the Participant, Following the Administration of at Least 1 Course of CBL-514.39
Other pre-specifiedNumber of Participants With Treatment-emergent Adverse Events (TEAEs)

Number of participants with TEAEs

Time frame:
From baseline until the end of follow-up, up to 17 weeks
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsCBL-514 up to 320mg
Mild14
Moderate13
Other pre-specifiedNumber of Treatment-emergent Adverse Events (TEAEs)

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

Time frame:
From baseline until the end of follow-up, up to 17 weeks
Reported as:
Count of units · Event
Number of Treatment-emergent Adverse Events (TEAEs)
EventCBL-514 up to 320mg
Mild210
Moderate105
Other pre-specifiedNumber of Participants With Adverse Events of Special Interest

Number of participants with adverse events of special interest

Time frame:
From baseline until the end of follow-up, up to 17 weeks
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest
ParticipantsCBL-514 up to 320mg
Number of Participants With Adverse Events of Special Interest3
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 baseline until the end of follow-up, up to 17 weeks
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
ParticipantsCBL-514 up to 320mg
Hematology0
Biochemistry0
Coagulation1
Urinalysis tests0

Adverse events

Collected over From baseline until the end of follow-up, up to 17 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CBL-514 up to 320mg0/23 (0%)1/23 (4.3%)18/23 (78.3%)
Most frequent serious events
Most frequent serious events
EventCBL-514 up to 320mg
HypersensitivityImmune system disorders1/23
Obstructive airways disorderRespiratory, thoracic and mediastinal disorders1/23
Most frequent other events
Most frequent other events
EventCBL-514 up to 320mg
Injection site painGeneral disorders16/23
Injection site erythemaGeneral disorders14/23
Injection site pruritusGeneral disorders14/23
Injection site swellingGeneral disorders14/23
Injection site bruisingGeneral disorders13/23
Injection site warmthGeneral disorders10/23
Injection site discolourationGeneral disorders7/23
Injection site indurationGeneral disorders5/23
UrticariaSkin and subcutaneous tissue disorders2/23

Baseline characteristics

Age, Continuous
Age, Continuous(Years)CBL-514 up to 320mg
Mean48.1 ± 10.8
Sex/Gender, Customized
Sex/Gender, Customized(Participants)CBL-514 up to 320mg
Female23
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CBL-514 up to 320mg
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White22
More than one race0
Unknown or Not Reported1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CBL-514 up to 320mg
Hispanic or Latino5
Not Hispanic or Latino18
Unknown or Not Reported0
Total Scores of the Modified Hexsel Cellulite Severity Scale
Total Scores of the Modified Hexsel Cellulite Severity Scale(scores)CBL-514 up to 320mg
Mean6.5 ± 1.0
07

Study locations

5 sites
  • Investigational Site 6
    Encinitas, California 92024, United States
  • Investigational Site 1
    Encino, California 91436, United States
  • Investigational Site 3
    San Diego, California 92121, United States
  • Investigational Site 4
    Coral Gables, Florida 33146, United States
  • Investigational Site 2
    New York, New York 10022, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 15, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT05836779
Lead sponsor
Caliway Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
May 1, 2023
Start date
May 10, 2023
Primary completion
Nov 29, 2023
Completion
Jan 5, 2024
Results posted
Jul 9, 2026
Last update
Jul 9, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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