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
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.
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.
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:
Exclusion Criteria:
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:
Participant who has had the following surgical or aesthetic procedures:
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.
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
CBL-514 will be administered at the raised area of cellulite.
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
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
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
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
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
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
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
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
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
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
| Milestone | CBL-514 up to 320mg |
|---|---|
| Started | 23 |
| Completed | 14 |
| Not completed | 9 |
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.
| Scores on a scale | CBL-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 |
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
| Thigh | CBL-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 |
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.
| Scores on a scale | CBL-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 |
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.
| Thigh | CBL-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 |
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".
| Thigh | CBL-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 |
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".
| Thigh | CBL-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 |
Number of participants with TEAEs
| Participants | CBL-514 up to 320mg |
|---|---|
| Mild | 14 |
| Moderate | 13 |
Number of individual TEAEs following administration of 1 course of CBL-514
| Event | CBL-514 up to 320mg |
|---|---|
| Mild | 210 |
| Moderate | 105 |
Number of participants with adverse events of special interest
| Participants | CBL-514 up to 320mg |
|---|---|
| Number of Participants With Adverse Events of Special Interest | 3 |
Laboratory tests include assessment of hematology, biochemistry, coagulation, and urinalysis tests
| Participants | CBL-514 up to 320mg |
|---|---|
| Hematology | 0 |
| Biochemistry | 0 |
| Coagulation | 1 |
| Urinalysis tests | 0 |
Collected over From baseline until the end of follow-up, up to 17 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBL-514 up to 320mg | 0/23 (0%) | 1/23 (4.3%) | 18/23 (78.3%) |
| Event | CBL-514 up to 320mg |
|---|---|
| HypersensitivityImmune system disorders | 1/23 |
| Obstructive airways disorderRespiratory, thoracic and mediastinal disorders | 1/23 |
| Event | CBL-514 up to 320mg |
|---|---|
| Injection site painGeneral disorders | 16/23 |
| Injection site erythemaGeneral disorders | 14/23 |
| Injection site pruritusGeneral disorders | 14/23 |
| Injection site swellingGeneral disorders | 14/23 |
| Injection site bruisingGeneral disorders | 13/23 |
| Injection site warmthGeneral disorders | 10/23 |
| Injection site discolourationGeneral disorders | 7/23 |
| Injection site indurationGeneral disorders | 5/23 |
| UrticariaSkin and subcutaneous tissue disorders | 2/23 |
| Age, Continuous(Years) | CBL-514 up to 320mg |
|---|---|
| Mean | 48.1 ± 10.8 |
| Sex/Gender, Customized(Participants) | CBL-514 up to 320mg |
|---|---|
| Female | 23 |
| Race (NIH/OMB)(Participants) | CBL-514 up to 320mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Ethnicity (NIH/OMB)(Participants) | CBL-514 up to 320mg |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Total Scores of the Modified Hexsel Cellulite Severity Scale(scores) | CBL-514 up to 320mg |
|---|---|
| Mean | 6.5 ± 1.0 |
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Caliway Biopharmaceuticals Co., Ltd.