Subcutaneous FatPhase 2NCT04575467

A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)

A Phase 2 study testing CBL-514 in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study. The primary objectives are to evaluate the safety and tolerability of injection lipolysis with CBL-514. It will be followed by a parallel-arm multiple-dose design in Stage 2. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Subcutaneous Fat
What is being tested?: CBL-514
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteAustralia
Study dates: 9 Dec 2020to 8 Dec 2021
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) >18.5 and <32 kg/m2 and body weight ≥50 kg at Screening and Day 1.
Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm (15.0 mm) and up to 5.00 cm (50.0 mm) measured by ultrasound, surrounding the center of treatment area at Screening and Day 1.
Subject has stable body weight (identified as ≤ 5% weight change) for at least 3 months before Screening and during the study.
Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and smoking habit) for at least 3 months before Screening and during the study.
Voluntarily signs the Informed Consent Form (ICF) 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 subject 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 investigational product (IP) dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method.
Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-menopausal (e.g., defined as at least 50 years with ≥12 months of amenorrhea with a follicle stimulating hormone (FSH) >40 IU/L) are considered to be of non-childbearing potential. Subjects who are not of childbearing potential are not required to use contraception.
Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
Subject has fasting hemoglobin A1c (HbA1c) ≥ 9%, delayed would healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
Subject with active or prior history of malignancies within 5 years before Screening or being worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin would be eligible as per Investigator's discretion.

Show all 31Show fewer

Subject with a history of human immunodeficiency virus (HIV)-1, infection or subjects with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
Subjects with any hepatic medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
Subject has abnormal skin or local skin conditions at the treatment area, which in the opinion of Investigator, is inappropriate to participate in the study, including but not limited to any of the following:
Skin manifestations of a systemic disease,
Any abnormality of the skin or soft tissues of the area to be treated,
Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area to be treated,
Skin folding on treatment area when the subject is in the supine 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.
Subject who has undergone the following procedures:
Previous surgery in the anticipated treatment area,
Cardiac pacemakers or any implantable electrical device,
Metal implants of any type in the area to be treated,
Esthetic procedure i.e. liposuction to the region to be treated,
Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, low level laser therapy (LLLT), lipolysis injection to the region to be treated within 12 months before Screening or during the study.
Subject is on prescription or over-the-counter (OTC) weight reduction medication or weight reduction programs within 3 months before Screening or during the study.
Subject is undergoing chronic steroid or immunosuppressive therapy.
Requiring continual use of the following therapeutic agents during the study: S mephenytoin (Mesantoin), terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, etc.).
If a subject needs to use the above mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used at least for 48 hours prior to dosing and until 24 hours post-dose.
Unable to receive topical anesthesia (e.g., history of hypersensitivity to Benzocaine, lidocaine, or Tetracaine).
Subjects with known allergies or sensitivities to the IP or its components.
Subjects 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).
Subjects with inadequate renal function, defined as abnormal serum creatinine, and urea >1.5 × ULN or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Subjects who are currently on dialysis should be excluded.
Use of other investigational drug or device within 4 weeks prior to Screening

Trial locations and contacts

1 site in 1 country.

Australia1 site

Investigational Site
Melbourne, Victoria

Other trials in Australia

About this study

Official title: A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat (Stage 1)

Conditions: Subcutaneous Fat
Being tested: CBL-514

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBL-514Drug
CBL-514 will be administered via injection into the subcutaneous adipose layer.

Study groups in NCT04575467
Study group	Role	What they receive
CBL-514 320 mg	Experimental	CBL-514 will be administered via injection into the thigh subcutaneous adipose layer. Receives: Drug: CBL-514
CBL-514 480 mg	Experimental	CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. Receives: Drug: CBL-514
CBL-514 640 mg	Experimental	CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. Receives: Drug: CBL-514
CBL-514 800 mg	Experimental	CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. Receives: Drug: CBL-514

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Treatment Emergent Adverse Events
Number of treatment emergent adverse events (TEAEs)
Measured: Up to 4 weeks after treatment
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
The clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test
Measured: Up to 4 weeks after treatment
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate
Measured: Up to 4 weeks after treatment
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
ECG parameters include heart rate, RR interval, PR interval, QT interval, QTc interval, and QRS interval
Measured: Up to 4 weeks after treatment
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems
Measured: Up to 4 weeks after treatment
Number of Participants With Injection Site Reactions
Injection site reactions include but not limited to redness, swelling, bruising, tenderness, itching, pain, warmth, discoloration and hardness
Measured: Up to 4 weeks after treatment

Secondary outcomes (2)

Change in Subcutaneous Fat Thickness
Change in subcutaneous fat thickness as measured by ultrasound compared to Baseline. No efficacy assessments were done for Group 1 of Stage 1 study.
Measured: Up to 4 weeks after treatment
Change in Subcutaneous Fat Volume
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.
Measured: Up to 4 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20208 Dec 2021

First posted5 Oct 2020
Study start9 Dec 2020
Primary completion15 Nov 2021
Study completion8 Dec 2021

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 Subcutaneous FatStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04575467
Sponsor's protocol ID: CBL-0202
Status last verified: Jul 2024
First submitted: 19 Aug 2020
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Subcutaneous Fat trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal and Thigh Subcutaneous Fat (Stage 1)
ClinicalTrials.gov ID: NCT04575467
Acronym / sponsor ID: CBL-0202
Conditions: Subcutaneous Fat
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Dec 2020 (actual)
Primary completion: 15 Nov 2021 (actual)
Study completion: 8 Dec 2021 (actual)
First posted: 5 Oct 2020 (actual)
Results: Posted 28 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CBL-514 320 mg	Experimental	Drug: CBL-514CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
CBL-514 480 mg	Experimental	Drug: CBL-514CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
CBL-514 640 mg	Experimental	Drug: CBL-514CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
CBL-514 800 mg	Experimental	Drug: CBL-514CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Body mass index (BMI) >18.5 and <32 kg/m2 and body weight ≥50 kg at Screening and Day 1.
Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm (15.0 mm) and up to 5.00 cm (50.0 mm) measured by ultrasound, surrounding the center of treatment area at Screening and Day 1.
Subject has stable body weight (identified as ≤ 5% weight change) for at least 3 months before Screening and during the study.
Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and smoking habit) for at least 3 months before Screening and during the study.
Voluntarily signs the Informed Consent Form (ICF) 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 (31 listed)

Female subject 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 investigational product (IP) dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method.
Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-menopausal (e.g., defined as at least 50 years with ≥12 months of amenorrhea with a follicle stimulating hormone (FSH) >40 IU/L) are considered to be of non-childbearing potential. Subjects who are not of childbearing potential are not required to use contraception.
Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
Subject has fasting hemoglobin A1c (HbA1c) ≥ 9%, delayed would healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).

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-514CBL-514 will be administered via injection into the subcutaneous adipose layer.	Drug	CBL-514 320 mg, CBL-514 480 mg, CBL-514 640 mg, CBL-514 800 mg

Primary outcome

Number of Treatment Emergent Adverse Events
Time frame: Up to 4 weeks after treatment
Number of treatment emergent adverse events (TEAEs)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Time frame: Up to 4 weeks after treatment
The clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Up to 4 weeks after treatment
Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Time frame: Up to 4 weeks after treatment
ECG parameters include heart rate, RR interval, PR interval, QT interval, QTc interval, and QRS interval
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Time frame: Up to 4 weeks after treatment
Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems
Number of Participants With Injection Site Reactions
Time frame: Up to 4 weeks after treatment
Injection site reactions include but not limited to redness, swelling, bruising, tenderness, itching, pain, warmth, discoloration and hardness

2 secondary outcomes

Change in Subcutaneous Fat Thickness
Time frame: Up to 4 weeks after treatment
Change in Subcutaneous Fat Volume
Time frame: Up to 4 weeks after treatment

Results and safety

Results posted to the registry on 28 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBL-514 320 mg	6	6
CBL-514 480 mg	7	6
CBL-514 640 mg	6	6
CBL-514 800 mg	6	6

Primary outcome: Number of Treatment Emergent Adverse Events

Time frame: Up to 4 weeks after treatment. Number. Unit: number of events

Measure	CBL-514 320 mg n = 6	CBL-514 480 mg n = 7	CBL-514 640 mg n = 6	CBL-514 800 mg n = 6
Value	103	57	69	61

Population analysed: Safety Population

Primary outcome: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values

Time frame: Up to 4 weeks after treatment. Count of participants. Unit: Participants

Measure	CBL-514 320 mg n = 6	CBL-514 480 mg n = 7	CBL-514 640 mg n = 6	CBL-514 800 mg n = 6
Value	0	0	0	1

Population analysed: Safety Population

Primary outcome: Number of Participants With Clinically Significant Abnormalities in Vital Signs

Time frame: Up to 4 weeks after treatment. Count of participants. Unit: Participants

Measure	CBL-514 320 mg n = 6	CBL-514 480 mg n = 7	CBL-514 640 mg n = 6	CBL-514 800 mg n = 6
Value	0	0	0	0

Population analysed: Safety Population

Primary outcome: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

Time frame: Up to 4 weeks after treatment. Count of participants. Unit: Participants

Measure	CBL-514 320 mg n = 6	CBL-514 480 mg n = 7	CBL-514 640 mg n = 6	CBL-514 800 mg n = 6
Value	0	0	0	0

Population analysed: Safety Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 weeks after treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBL-514 320 mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
CBL-514 480 mg	0 of 7 (0%)	7 of 7 (100%)	0 of 7
CBL-514 640 mg	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
CBL-514 800 mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site 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 in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in Australia.

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 5 inclusion and 31 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 28 Mar 2024). 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?

Number of Treatment Emergent Adverse Events (time frame: Up to 4 weeks after treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04575467.

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 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.