Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2) (NCT NCT05836779)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

From baseline to 4 weeks after the final treatment visit

Results posted on

2026-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	CBL-514 up to 320mg Participants received up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Overall Study STARTED	23
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBL-514 up to 320mg n=44 thighs Participants received up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Age, Continuous	48.1 Years STANDARD_DEVIATION 10.8 • n=20 Participants
Sex/Gender, Customized Female	23 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants
Race (NIH/OMB) White	22 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Total Scores of the Modified Hexsel Cellulite Severity Scale	6.5 scores STANDARD_DEVIATION 1.0 • n=44 thighs

PRIMARY outcome

Timeframe: From baseline to 4 weeks after the final treatment visit

Population: There were 23 participants with 46 thighs randomized at baseline. However, one of the participants was identified violating the exclusion criteria, and hence was removed from the efficacy analysis.

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.

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=44 Thigh Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
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 Scores on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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. 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

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=44 Thigh Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
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 Thigh

SECONDARY outcome

Timeframe: From baseline to 12 weeks after the final treatment visit

Population: There were 23 participants with 46 thighs randomized at baseline. However, one of the participants was identified violating the exclusion criteria, and hence was removed from the efficacy analysis.

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.

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=44 Thigh Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
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 Scores on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: From baseline to 4 weeks after the final treatment visit

Population: There were 23 participants with 46 thighs randomized at baseline. However, one of the participants was identified violating the exclusion criteria, and hence was removed from the efficacy analysis.

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.

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=44 Thigh Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
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 Thigh

SECONDARY outcome

Timeframe: 4 weeks after the final treatment visit

Population: There were 23 participants with 46 thighs randomized at baseline. However, one of the participants was identified violating the exclusion criteria, and hence was removed from the efficacy analysis.

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".

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=44 Thigh Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
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 Thigh

SECONDARY outcome

Timeframe: 4 weeks after the final treatment visit

Population: There were 23 participants with 46 thighs randomized at baseline. However, one of the participants was identified violating the exclusion criteria, and hence was removed from the efficacy analysis. In addition, another one of the participants failed to report the GAIS score. As a result, a total of 21 participants with 42 thighs were included in this efficacy analysis.

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".

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=42 Thigh Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
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 Thigh

OTHER_PRE_SPECIFIED outcome

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

Population: Safety Population

Number of participants with TEAEs

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=23 Participants Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Mild	14 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Moderate	13 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: Safety Population

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

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=315 Event Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Number of Treatment-emergent Adverse Events (TEAEs) Mild	210 Event
Number of Treatment-emergent Adverse Events (TEAEs) Moderate	105 Event

OTHER_PRE_SPECIFIED outcome

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

Population: Safety Population

Number of participants with adverse events of special interest

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=23 Participants Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Number of Participants With Adverse Events of Special Interest	3 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: Safety Population

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

Outcome measures

Outcome measures
Measure	CBL-514 up to 320mg n=23 Participants Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests Hematology	0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests Biochemistry	0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests Coagulation	1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests Urinalysis tests	0 Participants

Adverse Events

CBL-514 up to 320mg

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CBL-514 up to 320mg n=23 participants at risk Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
Immune system disorders Hypersensitivity	4.3% 1/23 • From baseline until the end of follow-up, up to 17 weeks
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	4.3% 1/23 • From baseline until the end of follow-up, up to 17 weeks

Other adverse events

Other adverse events
Measure	CBL-514 up to 320mg n=23 participants at risk Participants will receive up to 320 mg per treatment session at intervals of approximately 4 weeks for up to a maximum of 2 treatments.
General disorders Injection site pain	69.6% 16/23 • From baseline until the end of follow-up, up to 17 weeks
General disorders Injection site erythema	60.9% 14/23 • From baseline until the end of follow-up, up to 17 weeks
General disorders Injection site pruritus	60.9% 14/23 • From baseline until the end of follow-up, up to 17 weeks
General disorders Injection site swelling	60.9% 14/23 • From baseline until the end of follow-up, up to 17 weeks
General disorders Injection site warmth	43.5% 10/23 • From baseline until the end of follow-up, up to 17 weeks
General disorders Injection site bruising	56.5% 13/23 • From baseline until the end of follow-up, up to 17 weeks
General disorders Injection site discolouration	30.4% 7/23 • From baseline until the end of follow-up, up to 17 weeks
General disorders Injection site induration	21.7% 5/23 • From baseline until the end of follow-up, up to 17 weeks
Skin and subcutaneous tissue disorders Urticaria	8.7% 2/23 • From baseline until the end of follow-up, up to 17 weeks

Additional Information

Tim Wu

Caliway Biopharmaceuticals

Phone: +886226971355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place