Subcutaneous FatPhase 2NCT04897412
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)
A Phase 2 study testing CBL-514 Injection in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 5 sites in 2 countries.
Trial summary
The Stage 2 of this phase 2 study will be a randomized, single-blind, placebo-controlled, parallel, and multiple-dose study to assess the efficacy, safety, and subject satisfaction of CBL-514. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Feb 2022to 22 Mar 2023
- 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) greater than 18.5 and less than 35 kg/m2 and body weight greater than or equal to 50 kg at Screening and Day 1.
- Subject has subcutaneous fat thickness surrounding the center of localized area of treatment. For stage 2, abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 cm (80.0 mm) by pinch method (measured by calibrated caliper) at Screening.
- Subject has stable body weight (identified as less than or equal to 5% weight change per subject report) 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) per subject 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 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 IP dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method.
- Note: Subjects who are not of childbearing potential are not required to use contraception. Females with no childbearing potential are defined as who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-menopausal (defined as at least 50 years with greater than or equal to 12 months of amenorrhea with a FSH greater than 40 IU/L).
- Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
- Subject has hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed wound 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.
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- 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.
- Subject with a history of Trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experience vasovagal syncope and faint or pass out at the sight of blood or a needle.
- 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 and fat folding on abdomen
- 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 abdominal or thigh subcutaneous fat,
- Tattoos on the area to be treated.
- Subject who has undergone the following procedures:
- Previous surgery which caused scar tissues on the anticipated treatment area before Screening or during the study, except laparoscopic surgery and surgery which causes very small scar tissues would be eligible as per Investigator's discretion,
- Liposuction to the region to be treated before Screening or during the study,
- Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to the region to be treated within 12 months before Screening or during the study.
- Using medication which is delivered via subcutaneous injection at the treatment area during the study period.
- Subject is on prescription or 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, with the exception of oral steroid inhalation indicated for asthma management or topical steroid application for skin conditions that are not directly applied or indirectly affect the treatment area.
- Requiring continual use of the following therapeutic agents during the study: terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, etc.), any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk.
- 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 and until 1 day post-dose.
- Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
- Subjects with known allergies or sensitivities to the study treatment or its components.
- Subjects with liver cirrhosis or 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) greater than 3.0 × upper limit of normal (ULN), or 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.
- Subjects with any renal impairment, defined as abnormal serum creatinine, and urea greater than 1.5 × ULN or estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2. Subjects who are currently on dialysis should be excluded.
- Subjects 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 to exclude pre-existing renal disease or associated dysfunction. If mild decrease in eGFR is assessed by the Investigator as not clinically significant or not related to dysfunction, the subjects may be eligible upon the Investigator's assessment.
- Use of other investigational drug or device within 12 weeks prior to Screening.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Investigational site 4
Austin, Texas, 78759
Investigational site 1
Chicago, Illinois, 60611
Investigational site 3
Nashville, Tennessee, 37215
Investigational site 2
Omaha, Nebraska, 68144
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 2)
The Stage 2 of this phase 2 study will be a randomized, single-blind, placebo-controlled, parallel, and multiple-dose study to assess the efficacy, safety, and subject satisfaction of CBL-514.
Read the detailed description
This is the 2nd stage of a 2-Stage adaptive design, phase 2 study to evaluate the efficacy, safety and tolerability of CBL- 514 injection for reducing abdominal subcutaneous fat. Stage 2 will be conducted as a single-blind, placebo-controlled study.
CBL-514 will be administered via injection into the subcutaneous adipose layer on abdomen. Each subject will receive up to 4 treatments of allocated CBL-514 (2 mg/cm2) or placebo administered on abdomen, once every 4 weeks and complete 2 follow-up visits after the last treatment. The maximum dose is 600 mg per treatment depending on the level of fat accumulation on subject's abdomen.
- Conditions
- Subcutaneous Fat
- Being tested
- CBL-514 Injection, Placebo
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.
PlaceboOther
Sodium Chloride (0.9% NaCl) placebo for injection
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 Injection | Experimental | Participant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 4 treatments. Receives: Drug: CBL-514 Injection |
| Placebo: 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 4 weeks for up to a maximum of 4 treatments. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by ultrasound from Baseline to follow-up visits compared with placebo.
Measured: From Visit 2 (Baseline) up to 8 weeks after last treatment
Secondary outcomes (5)
Proportion of subjects who lose at least 200 mL of subcutaneous fat compared with placebo
The proportion of subjects who lose at least 200 mL of subcutaneous fat as measured by ultrasound from Baseline to follow-up visits compared with placebo.
Measured: From Visit 2 (Baseline) up to 8 weeks after last treatment
Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous fat volume in CBL-514 group
Evaluate the number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous fat volume over the treated area as measured by ultrasound in CBL-514 group.
Measured: From Visit 2 (Baseline) up to 8 weeks after last treatment
Change of subcutaneous fat volume over the treated area compared with placebo
Change of subcutaneous fat volume over the treated area as measured by ultrasound from Baseline to follow-up visits compared with placebo.
Measured: From Visit 2 (Baseline) up to 8 weeks after last treatment
Change of subcutaneous fat volume over the treated area of the CBL-514 group compared with individual baseline
Change of subcutaneous fat volume over the treated area of the CBL-514 group as measured by ultrasound compared with individual Baseline.
Measured: From Visit 2 (Baseline) up to 8 weeks after last treatment
Evaluation of safety following up to 4 courses of CBL-514 compared with placebo
Safety as assessed by recording of TEAEs, laboratory assessments, vital signs, ECGs, physical examinations, and ISRs compared with placebo.
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.
- First posted21 May 2021
- Study start14 Feb 2022
- Primary completion22 Feb 2023
- Study completion22 Mar 2023
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 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
- NCT04897412
- Sponsor's protocol ID
- CBL-0202(Stage 2)
- Status last verified
- Apr 2023
- First submitted
- 18 May 2021
- Last updated
- 24 Apr 2023
- 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 24 Apr 2023. 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 2)
- ClinicalTrials.gov ID
- NCT04897412
- Acronym / sponsor ID
- CBL-0202(Stage 2)
- Conditions
- Subcutaneous Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 21 May 2021 (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.
The Stage 2 of this phase 2 study will be a randomized, single-blind, placebo-controlled, parallel, and multiple-dose study to assess the efficacy, safety, and subject satisfaction of CBL-514.
Detailed description
This is the 2nd stage of a 2-Stage adaptive design, phase 2 study to evaluate the efficacy, safety and tolerability of CBL- 514 injection for reducing abdominal subcutaneous fat. Stage 2 will be conducted as a single-blind, placebo-controlled study.
CBL-514 will be administered via injection into the subcutaneous adipose layer on abdomen. Each subject will receive up to 4 treatments of allocated CBL-514 (2 mg/cm2) or placebo administered on abdomen, once every 4 weeks and complete 2 follow-up visits after the last treatment. The maximum dose is 600 mg per treatment depending on the level of fat accumulation on subject's abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBL-514 Injection | Experimental | Drug: CBL-514 InjectionParticipant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 4 treatments. |
| Placebo: 0.9% Sodium Chloride | Placebo comparator | Other: PlaceboParticipant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 4 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) greater than 18.5 and less than 35 kg/m2 and body weight greater than or equal to 50 kg at Screening and Day 1.
- Subject has subcutaneous fat thickness surrounding the center of localized area of treatment. For stage 2, abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and up to 8.00 cm (80.0 mm) by pinch method (measured by calibrated caliper) at Screening.
- Subject has stable body weight (identified as less than or equal to 5% weight change per subject report) 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) per subject report for at least 3 months before Screening and during the study.
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 IP dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method.
- Note: Subjects who are not of childbearing potential are not required to use contraception. Females with no childbearing potential are defined as who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are post-menopausal (defined as at least 50 years with greater than or equal to 12 months of amenorrhea with a FSH greater than 40 IU/L).
- Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
- Subject has hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed wound 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-514 InjectionFormulated as an injectable CBL-514 solution at a concentration of 5 mg/mL. | Drug | CBL-514 Injection |
| PlaceboSodium Chloride (0.9% NaCl) placebo for injection | Other | Placebo: 0.9% Sodium Chloride |
Primary outcome
Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo
Time frame: From Visit 2 (Baseline) up to 8 weeks after last treatment
The proportion of subjects who lose at least 150 mL of subcutaneous fat as measured by ultrasound from Baseline to follow-up visits compared with placebo.
5 secondary outcomes
Proportion of subjects who lose at least 200 mL of subcutaneous fat compared with placebo
Time frame: From Visit 2 (Baseline) up to 8 weeks after last treatment
Number of treatments required to first occurrence of reducing at least 150 mL of subcutaneous fat volume in CBL-514 group
Time frame: From Visit 2 (Baseline) up to 8 weeks after last treatment
Change of subcutaneous fat volume over the treated area compared with placebo
Time frame: From Visit 2 (Baseline) up to 8 weeks after last treatment
Change of subcutaneous fat volume over the treated area of the CBL-514 group compared with individual baseline
Time frame: From Visit 2 (Baseline) up to 8 weeks after last treatment
Evaluation of safety following up to 4 courses of CBL-514 compared with placebo
Time frame: Up to 8 weeks after last 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 24 Apr 2023.
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBL-514 Injection in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 5 sites in 2 countries.
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 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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. 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?
Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo (time frame: From Visit 2 (Baseline) 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?
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 24 Apr 2023.