Subcutaneous FatPhase 2NCT05736107
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
A Phase 2 study testing CBL-514 Injection and 0.9% Sodium Chloride in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in United States.
Trial summary
This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat. 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 Injection and 0.9% Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 20 May 2024
- 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 or female, aged 18 years to 64 years old (at Screening), inclusive.
- Body mass index (BMI) > 18.5 and < 30 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
- Participant has abdominal fat graded by the Investigator as Grade 3 (moderate) or Grade 4 (severe) using the Clinician-Reported Abdominal Fat Rating Scale via live evaluation at Screening.
- Participant has stable body weight (identified as ≤ 3 kg weight change per participant report) for at least 3 months before Screening and during the study.
- Participant who has maintained 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 (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 participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose.
- Note: Participants 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 post-menopausal (defined as at least 50 years of age with greater than or equal to 12 months of amenorrhea with a follicle stimulating hormone (FSH) greater than 30 IU/L).
- Participant diagnosed with coagulation disorders or who is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements that impede coagulation or platelet aggregation.
- Participant has hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed wound healing, or poorly controlled diabetes defined as requiring a change in glucose control medications (other than day to day variations in insulin requirements) within the 6 months prior to Screening or for whom a change in glucose control medications is anticipated during the study, or any diabetic risks that, in the opinion of Investigator, make the individual an inappropriate candidate for the study.
- Participant with active or prior history of malignancies within 5 years before Screening or currently being evaluated for a possible malignancy, with the exception of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin at Investigator's discretion.
- Participant with a history of human immunodeficiency virus (HIV)-1 infection or participant with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
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- Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope and faints at the sight of blood or a needle.
- Participant with folding fat or skin on abdomen in standing position.
- Participant with severe or very severe abdominal visceral fat assessed by the Investigator using the visceral fat scale.
- Participant with ventral abdominal or umbilical hernia or previous repair of same.
- Participant has abnormal skin or local skin conditions at the treatment area, which, in the opinion of Investigator, would increase risk to the participant or inhibit safety or efficacy evaluation, 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, such as scars, striae, dyspigmentation, etc.,
- Asymmetrical fat on abdomen,
- Lipomatosis syndromes (familial lipomatosis, nevus lipomatosis, Dercum's disease, etc.),
- Skin laxity on abdomen,
- Sensory loss or dysesthesia in the area to be treated,
- Tattoo(s) on the front and/or lateral side of abdomen.
- Participant who has undergone the following procedures:
- Previous surgery that caused scar tissues on the anticipated treatment area before Screening or during the study, with the exception of laparoscopic surgery and surgery that resulted in minimal scar tissue determined at Investigator's discretion,
- Liposuction or abdominoplasty to the region to be treated before Screening or during the study,
- Aesthetic procedure for body contouring or fat reduction, e.g., cryolipolysis, ultrasonic lipolysis, low level laser therapy, EMSculpt, lipolysis injection to the region to be treated within 12 months before Screening or during the study.
- Using medication that is delivered via subcutaneous injection at the treatment area within 4 weeks before Screening or during the study.
- Participant is on prescription or OTC weight reduction medication, weight reduction programs, or use of any GLP-1 agonists (e.g., semaglutide, terzepatide, liraglutide, etc.) (oral or injectable) within 6 months before Screening or during the study.
- Participant is undergoing chronic steroid or immunosuppressive therapy, with the exception of oral steroid inhalation indicated for asthma management or topical steroid application for skin conditions that are not directly applied to or indirectly affect the treatment area.
- Requiring continual use of any medication that is known to strongly inhibit or induce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk.
- Note: 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 prior to dosing and until 1 day post-dose.
- Unable to receive local anesthesia (e.g., history of hypersensitivity to lidocaine).
- Participant with known allergies or sensitivities to the IP or its components, medical history of urticaria, any drug allergy, or seasonal allergy that presents with skin-related symptoms. Participant with food allergies can be enrolled at the discretion of Investigator.
- Participant with liver cirrhosis, with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin (TBIL), or gamma-glutamyl transferase (GGT) greater than 3.0 × upper limit of normal (ULN), or with any hepatic medical condition that would interfere with assessment of safety or efficacy.
- Participant with any renal impairment, defined as:
- serum creatinine greater than 1.5 × ULN and blood urea nitrogen (BUN) greater than 1.5 × ULN, or
- estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2, or who is currently on dialysis.
- Note: Participant with an eGFR greater than or equal to 60 and less than 90 mL/min/1.73 m2 at Screening should be evaluated by the Investigator for pre-existing disease or associated dysfunction. If mild decrease in eGFR is deemed not clinically significant or not related to dysfunction by the Investigator, the participant will not be excluded unless the Investigator deems it necessary.
- Participant with contraindications to MRI imaging.
- Use of any investigational drug or device within 3 months prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.
Read the detailed description
A total of approximately 110 adult participants with moderate or severe abdominal fat as assessed by the Investigator via live evaluation using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at Screening will be enrolled. Each participant will receive up to 4 treatments of allocated CBL-514 (2 mg/cm²) or placebo administered subcutaneously to the abdomen, once every 3 weeks.
- Conditions
- Subcutaneous Fat
- Being tested
- CBL-514 Injection, 0.9% Sodium Chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL-514 InjectionDrug
Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.
0.9% Sodium ChlorideOther
Sodium Chloride (0.9% NaCl) placebo for injection
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 Injection | Experimental | Participant will receive CBL-514 2 mg/cm² administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments. Receives: Drug: CBL-514 Injection |
| 0.9% Sodium Chloride | Placebo comparator | Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments. Receives: Other: 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
The scale is a 5-point ordinal scale to assess the abdominal fat level
Measured: From baseline to 12 weeks after the final treatment
Secondary outcomes (4)
Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
The scale is a 5-point ordinal scale to assess the abdominal fat level
Measured: From baseline to 4 weeks and 8 weeks after the final treatment
Participants with at least 2-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
The scale is a 5-point ordinal scale to assess the abdominal fat level
Measured: From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Participants with at least 1-grade improvement reported by participant using the Patient-Reported Abdominal Fat Rating Scale
The scale is a 5-point ordinal scale to assess the abdominal fat level
Measured: From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Change in subcutaneous fat compared to baseline
Measured by MRI
Measured: From baseline to 4 weeks and 12 weeks after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 May 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 107 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
- NCT05736107
- Sponsor's protocol ID
- CBL-0204
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
- ClinicalTrials.gov ID
- NCT05736107
- Acronym / sponsor ID
- CBL-0204
- Conditions
- Subcutaneous Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.
Detailed description
A total of approximately 110 adult participants with moderate or severe abdominal fat as assessed by the Investigator via live evaluation using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at Screening will be enrolled. Each participant will receive up to 4 treatments of allocated CBL-514 (2 mg/cm²) or placebo administered subcutaneously to the abdomen, once every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBL-514 Injection | Experimental | Drug: CBL-514 InjectionParticipant will receive CBL-514 2 mg/cm² administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments. |
| 0.9% Sodium Chloride | Placebo comparator | Other: 0.9% Sodium ChlorideParticipant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, aged 18 years to 64 years old (at Screening), inclusive.
- Body mass index (BMI) > 18.5 and < 30 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
- Participant has abdominal fat graded by the Investigator as Grade 3 (moderate) or Grade 4 (severe) using the Clinician-Reported Abdominal Fat Rating Scale via live evaluation at Screening.
- Participant has stable body weight (identified as ≤ 3 kg weight change per participant report) for at least 3 months before Screening and during the study.
- Participant who has maintained 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.
Key exclusion criteria (36 listed)
- Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose.
- Note: Participants 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 post-menopausal (defined as at least 50 years of age with greater than or equal to 12 months of amenorrhea with a follicle stimulating hormone (FSH) greater than 30 IU/L).
- Participant diagnosed with coagulation disorders or who is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements that impede coagulation or platelet aggregation.
- Participant has hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed wound healing, or poorly controlled diabetes defined as requiring a change in glucose control medications (other than day to day variations in insulin requirements) within the 6 months prior to Screening or for whom a change in glucose control medications is anticipated during the study, or any diabetic risks that, in the opinion of Investigator, make the individual an inappropriate candidate for the study.
- Participant with active or prior history of malignancies within 5 years before Screening or currently being evaluated for a possible malignancy, with the exception of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin at Investigator'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 InjectionFormulated as an injectable CBL-514 solution at a concentration of 5 mg/mL. | Drug | CBL-514 Injection |
| 0.9% Sodium ChlorideSodium Chloride (0.9% NaCl) placebo for injection | Other | 0.9% Sodium Chloride |
Primary outcome
Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
Time frame: From baseline to 12 weeks after the final treatment
The scale is a 5-point ordinal scale to assess the abdominal fat level
4 secondary outcomes
Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
Time frame: From baseline to 4 weeks and 8 weeks after the final treatment
Participants with at least 2-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale
Time frame: From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Participants with at least 1-grade improvement reported by participant using the Patient-Reported Abdominal Fat Rating Scale
Time frame: From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment
Change in subcutaneous fat compared to baseline
Time frame: From baseline to 4 weeks and 12 weeks after the final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
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 Injection and 0.9% Sodium Chloride in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site 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 6 inclusion and 36 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 22 Jul 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 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. Some participants in this study may receive a placebo. 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?
Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale (time frame: From baseline to 12 weeks after the final treatment). 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 22 Jul 2024.