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Subcutaneous FatPhase 2NCT04698642

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat

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 Phase 2a component of the study will be a randomized, open-label, parallel, and multiple dose study to further examine the safety and efficacy profile of 3 CBL-514 dose levels based on the results from Phase 1 of the study. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteAustralia
Study dates
3 Feb 2020to 12 Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Male/female aged 18 years to 64 years old (at Screening), inclusive.
  • Body mass index >18.5 and <35 kg/m2 and body weight ≥50 kg at Screening and Day 1.
  • Has WC between 80.0 cm and 110.0 cm at Screening and Day 1.
  • Subcutaneous fat thickness of at least 3.00 cm (30.0 mm) and up to 6.00 cm (60.0 mm) by pinch method (measured by calibrated caliper) surrounding the center of treatment area at Screening and Day 1.
  • Subject has stable body weight 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 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 12 weeks after the last study drug dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method. For details on contraception, refer section 6.11.
  • Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are postmenopausal (e.g., defined as at least 50 years with ≥12 months of amenorrhea with a follicle stimulating hormone >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 diabetes or glycated hemoglobin ≥6.5% (48 mmol/mol) or fasting blood sugar ≥7 mmol/L.
  • Subject has a clinically significant cardiovascular disease and abnormal findings in ECG.
  • Subject with active or prior history of malignancies (except for successfully treated basal cell carcinoma) within 5 years before Screening or being worked-up for a possible malignancy.
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  • Subject with a history of human immunodeficiency virus (HIV)-1, hepatitis B, or hepatitis C infections or subjects with active HIV, hepatitis B, or hepatitis C infections at Screening:
  • Active HIV infection: positive HIV Ag/Ab combo test;
  • Active hepatitis B virus (HBV) infection: positive HBV surface antigen (HBsAg). Subjects with negative HBsAg but with positive HBV core antibody, with or without positive HBV surface antibody will also be excluded. However, subjects with negative HBsAg, negative HBV core antibody, and positive HBV surface antibody may be included.
  • Active hepatitis C virus (HCV) infection: positive HCV antibody.
  • 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 abdominal wall in the area to be treated,
  • Skin or superficial tissue that does not lie flat on its own 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 abdominal area other than localized subcutaneous fat,
  • Tattoos on the area to be treated.
  • Subject who has hernia
  • Subject who has undergone the following procedures:
  • Previous open or laparoscopic abdominal 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 within 12 months before Screening or during the study,
  • Esthetic procedure i.e. cryolipolysis, ultrasonic lipolysis, low level laser therapy , lipolysis injection to the region to be treated within 6 months before Screening or during the study.
  • Subject is on prescription or over-the-counter 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:1 S-mephenytoin (Mesantoin), terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra).
  • 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 2 days prior to dosing until 1 day post-dose, whichever is later.
  • Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
  • Subjects with known allergies or sensitivities to the study drug and/or excipients
  • Subjects with inadequate liver function at Screening defined as aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, or gamma-glutamyl transferase >3.0 × 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

Other trials in Australia

About this study

Official title: A 2-stage, Phase 1/2a Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat (Phase 2a)

The Phase 2a component of the study will be a randomized, open-label, parallel, and multiple dose study to further examine the safety and efficacy profile of 3 CBL-514 dose levels based on the results from Phase 1 of the study.

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

    Both sides of the abdominal region will receive CBL-514.

Study groups in NCT04698642
Study groupRoleWhat they receive
CBL-514 180 mg, 1.2 mg/cm^2ExperimentalCBL-514 will be administrated with the grid spacing of 2.5 cm^2
Receives: Drug: CBL-514
CBL-514 240 mg, 1.6 mg/cm^2ExperimentalCBL-514 will be administrated with the grid spacing of 2.5 cm^2
Receives: Drug: CBL-514
CBL-514 300 mg, 2 mg/cm^2ExperimentalCBL-514 will be administrated with the grid spacing of 2.5 cm^2
Receives: Drug: CBL-514

What is being measured

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

  1. Change of abdominal subcutaneous fat volume

    Change of abdominal subcutaneous fat volume as measured by ultrasound around the treated area compared to Baseline

    Measured: Up to 8 weeks after last treatment

Secondary outcomes (7)

  1. Change of abdominal subcutaneous fat thickness

    Change of abdominal subcutaneous fat thickness as measured by ultrasound-determined subcutaneous fat thickness over the treated area compared to Baseline,

    Measured: Up to 8 weeks after last treatment

  2. Incidence of treatment emergent adverse events (TEAEs)

    Number of participants experiencing TEAEs and number of individual TEAEs among treatment groups by severity and relationship to investigational product (IP)

    Measured: Up to 8 weeks after last treatment

  3. Number of participants with clinically significant abnormalities in clinical laboratory values

    Clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test

    Measured: Up to 4 weeks after last treatment

  4. 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 8 weeks after last treatment

  5. 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 last treatment

  6. Number of participants with clinically significant abnormalities in physical examination

    Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems

    Measured: Up to 8 weeks after last treatment

  7. 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 8 weeks after last treatment

Timeline

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

  1. First posted7 Jan 2021
  2. Study start3 Feb 2020
  3. Primary completion12 Nov 2020
  4. Study completion12 Nov 2020

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04698642
Sponsor's protocol ID
CBL-16001(Phase 2a)
Status last verified
Jan 2021
First submitted
29 Dec 2020
Last updated
8 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 7 inclusion and 33 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 8 Jan 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change of abdominal subcutaneous fat volume (time frame: Up to 8 weeks after last treatment). 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 NCT04698642.

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 8 Jan 2021.

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