Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1) (NCT NCT04575467)
NCT ID: NCT04575467
Last Updated: 2024-08-09
Results Overview
Number of treatment emergent adverse events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 4 weeks after treatment
Results posted on
2024-08-09
Participant Flow
Participant milestones
| Measure |
CBL-514 320 mg
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
CBL-514 800 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
CBL-514 320 mg
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
CBL-514 800 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
Baseline characteristics by cohort
| Measure |
CBL-514 320 mg
n=6 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.5 years
n=99 Participants
|
48 years
n=107 Participants
|
31.5 years
n=206 Participants
|
51.5 years
n=7 Participants
|
51 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Australia
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Body Mass Index
|
26.08 kg/m2
STANDARD_DEVIATION 1.95 • n=99 Participants
|
25.16 kg/m2
STANDARD_DEVIATION 2.51 • n=107 Participants
|
26.15 kg/m2
STANDARD_DEVIATION 3.74 • n=206 Participants
|
25.97 kg/m2
STANDARD_DEVIATION 2.66 • n=7 Participants
|
25.81 kg/m2
STANDARD_DEVIATION 2.64 • n=31 Participants
|
|
Weight
|
69.46 kg
STANDARD_DEVIATION 7.58 • n=99 Participants
|
75.25 kg
STANDARD_DEVIATION 12.70 • n=107 Participants
|
65.93 kg
STANDARD_DEVIATION 9.01 • n=206 Participants
|
75.48 kg
STANDARD_DEVIATION 5.80 • n=7 Participants
|
71.68 kg
STANDARD_DEVIATION 9.65 • n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: Safety Population
Number of treatment emergent adverse events (TEAEs)
Outcome measures
| Measure |
CBL-514 320 mg
n=6 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events
|
103 number of events
|
57 number of events
|
69 number of events
|
61 number of events
|
PRIMARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: Safety Population
The clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test
Outcome measures
| Measure |
CBL-514 320 mg
n=6 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: Safety Population
Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate
Outcome measures
| Measure |
CBL-514 320 mg
n=6 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: Safety Population
ECG parameters include heart rate, RR interval, PR interval, QT interval, QTc interval, and QRS interval
Outcome measures
| Measure |
CBL-514 320 mg
n=6 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: ITT Population
Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems
Outcome measures
| Measure |
CBL-514 320 mg
n=6 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: Safety Population
Injection site reactions include but not limited to redness, swelling, bruising, tenderness, itching, pain, warmth, discoloration and hardness
Outcome measures
| Measure |
CBL-514 320 mg
n=6 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Number of Participants With Injection Site Reactions
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: ITT Population (Data not collected for participants that received the 320 mg injection)
Change in subcutaneous fat thickness as measured by ultrasound compared to Baseline. No efficacy assessments were done for Group 1 of Stage 1 study.
Outcome measures
| Measure |
CBL-514 320 mg
n=7 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Change in Subcutaneous Fat Thickness
|
-4.77 Absolute Change (mm) from Baseline
Standard Deviation 2.29
|
-4.85 Absolute Change (mm) from Baseline
Standard Deviation 2.02
|
-2.98 Absolute Change (mm) from Baseline
Standard Deviation 2.83
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeks after treatmentPopulation: ITT Population (Data not collected for participants that received the 320 mg injection)
Change in subcutaneous fat volume over the treated area as measured by ultrasound compared to Baseline. No efficacy assessments were done for Group 1 of Stage 1 study.
Outcome measures
| Measure |
CBL-514 320 mg
n=7 Participants
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 Participants
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 800 mg
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
|---|---|---|---|---|
|
Change in Subcutaneous Fat Volume
|
-114.40 Absolute change (mL) from Baseline
Standard Deviation 54.88
|
-155.20 Absolute change (mL) from Baseline
Standard Deviation 64.70
|
-119.17 Absolute change (mL) from Baseline
Standard Deviation 113.11
|
—
|
Adverse Events
CBL-514 320 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CBL-514 480 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CBL-514 640 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CBL-514 800 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBL-514 320 mg
n=6 participants at risk
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 participants at risk
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 participants at risk
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
CBL-514 800 mg
n=6 participants at risk
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Closed head injury with post concussive symptoms
|
0.00%
0/6 • Up to 4 weeks after treatment
|
0.00%
0/7 • Up to 4 weeks after treatment
|
16.7%
1/6 • Number of events 1 • Up to 4 weeks after treatment
|
0.00%
0/6 • Up to 4 weeks after treatment
|
Other adverse events
| Measure |
CBL-514 320 mg
n=6 participants at risk
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
|
CBL-514 480 mg
n=7 participants at risk
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
|
CBL-514 640 mg
n=6 participants at risk
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
CBL-514 800 mg
n=6 participants at risk
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
100.0%
6/6 • Number of events 12 • Up to 4 weeks after treatment
|
100.0%
7/7 • Number of events 7 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 6 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 6 • Up to 4 weeks after treatment
|
|
General disorders
Injection site bruising
|
100.0%
6/6 • Number of events 12 • Up to 4 weeks after treatment
|
85.7%
6/7 • Number of events 6 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 6 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 8 • Up to 4 weeks after treatment
|
|
General disorders
Injection site pain
|
100.0%
6/6 • Number of events 18 • Up to 4 weeks after treatment
|
85.7%
6/7 • Number of events 11 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 13 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 13 • Up to 4 weeks after treatment
|
|
General disorders
Injection site swelling
|
100.0%
6/6 • Number of events 12 • Up to 4 weeks after treatment
|
85.7%
6/7 • Number of events 6 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 6 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 6 • Up to 4 weeks after treatment
|
|
General disorders
Injection site pruritus
|
66.7%
4/6 • Number of events 10 • Up to 4 weeks after treatment
|
100.0%
7/7 • Number of events 7 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 6 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 7 • Up to 4 weeks after treatment
|
|
General disorders
Injection site warmth
|
100.0%
6/6 • Number of events 12 • Up to 4 weeks after treatment
|
71.4%
5/7 • Number of events 5 • Up to 4 weeks after treatment
|
50.0%
3/6 • Number of events 3 • Up to 4 weeks after treatment
|
100.0%
6/6 • Number of events 6 • Up to 4 weeks after treatment
|
|
General disorders
Injection site discolouration
|
100.0%
6/6 • Number of events 12 • Up to 4 weeks after treatment
|
85.7%
6/7 • Number of events 6 • Up to 4 weeks after treatment
|
50.0%
3/6 • Number of events 3 • Up to 4 weeks after treatment
|
16.7%
1/6 • Number of events 1 • Up to 4 weeks after treatment
|
|
General disorders
Injection site induration
|
100.0%
6/6 • Number of events 13 • Up to 4 weeks after treatment
|
57.1%
4/7 • Number of events 4 • Up to 4 weeks after treatment
|
33.3%
2/6 • Number of events 3 • Up to 4 weeks after treatment
|
66.7%
4/6 • Number of events 5 • Up to 4 weeks after treatment
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up to 4 weeks after treatment
|
28.6%
2/7 • Number of events 2 • Up to 4 weeks after treatment
|
16.7%
1/6 • Number of events 3 • Up to 4 weeks after treatment
|
16.7%
1/6 • Number of events 1 • Up to 4 weeks after treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place