CellulitePhase 2NCT05836779
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)
A Phase 2 study testing CBL-514 injection in people with Cellulite, run by Caliway Biopharmaceuticals Co., Ltd. at 5 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Cellulite
- What is being tested?
- CBL-514 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 May 2023to 5 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female aged 18 years to 64 years old (at Screening), inclusive.
- Have a BMI > 18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
- 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:
- Hexsel CSS item (A) 'number of evident depressions' score of ≥1
- Hexsel CSS item (B) 'depth of depressions' score of ≥ 1
- 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.
- 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.
Who cannot join
- 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).
- 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.
- 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.
- Participant has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG) at Investigator's (or designee's) discretion.
- 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.
- 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.
Show all 30Show fewer
- 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.
- 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.
- 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.
- 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:
- skin manifestations of a systemic disease
- any abnormality of the skin or soft tissues on the anticipated treatment area
- skin laxity on treatment area when the participant is in the standing position
- sensory loss or dysesthesia in the area to be treated
- evidence of any cause of enlargement in the area to be treated other than localized subcutaneous fat
- tattoos on the area to be treated
- participant with a propensity for keloid or hypertrophic scarring.
- Participant who has had the following surgical or aesthetic procedures:
- liposuction, cryolipolysis, ultrasonic lipolysis, low level laser therapy (LLLT), or lipolysis injection to the region to be treated before Screening
- 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
- massage to the region to be treated within 2 weeks before Screening and throughout study participation.
- 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.
- 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.
- Participant receives nonsteroidal anti-inflammatory drug (NSAID) including aspirin within 14 days prior to the IP administration.
- Participant is unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
- Participant with known allergies or sensitivities to the IP or its components.
- 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).
- 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.
- Use of other investigational product or device within 4 weeks prior to Screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Investigational Site 4
Coral Gables, Florida, 33146
Investigational Site 6
Encinitas, California, 92024
Investigational Site 1
Encino, California, 91436
Investigational Site 2
New York, New York, 10022
Investigational Site 3
San Diego, California, 92121
About this study
Official title: A Phase 2a, Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of CBL-514 Injection for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) Cellulite (Stage 2)
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.
- Conditions
- Cellulite
- Being tested
- CBL-514 injection
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL-514 injectionDrug
CBL-514 will be administered at the raised area of cellulite.
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 up to 320mg | Experimental | Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments. Receives: Drug: CBL-514 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 4 weeks after the final treatment visit
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 4 weeks after the final treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start10 May 2023
- Primary completion29 Nov 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Sheu, Study director, Caliway Biopharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836779
- Sponsor's protocol ID
- CBL-0201EFP (Stage 2)
- Status last verified
- Jun 2026
- First submitted
- 19 Apr 2023
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of CBL-514 Injection for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) Cellulite (Stage 2)
- ClinicalTrials.gov ID
- NCT05836779
- Acronym / sponsor ID
- CBL-0201EFP (Stage 2)
- Conditions
- Cellulite
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBL-514 up to 320mg | Experimental | Drug: CBL-514 injectionParticipants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female aged 18 years to 64 years old (at Screening), inclusive.
- Have a BMI > 18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
- 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.
- 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.
- 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.
Key exclusion criteria (30 listed)
- 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).
- 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.
- 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.
- Participant has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG) at Investigator's (or designee's) discretion.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBL-514 injectionCBL-514 will be administered at the raised area of cellulite. | Drug | CBL-514 up to 320mg |
Primary outcome
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.
Time frame: From baseline to 4 weeks after the final treatment visit
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Time frame: 4 weeks after the final treatment visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Sheu study director
Caliway Biopharmaceuticals Co., Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBL-514 injection in people with Cellulite, run by Caliway Biopharmaceuticals Co., Ltd. at 5 sites in United States.
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 8 inclusion and 30 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: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From baseline to 4 weeks after the final treatment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.