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CBL-514 for Reducing Abdominal Fat
Phase 2
Waitlist Available
Research Sponsored by Caliway Biopharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 8 weeks after the final treatment
Awards & highlights
Study Summary
This trial tests a drug to reduce fat under the skin, to see if it's safe, effective and tolerated.
Who is the study for?
Adults aged 18-64 with a BMI between 18.5 and 32, weighing at least 50 kg, having mild to severe abdominal fat without significant weight change or lifestyle changes in the past three months. Participants must not be pregnant, lactating, or planning pregnancy; males must use condoms. Excludes those with coagulation disorders, uncontrolled diabetes, recent malignancies (except certain skin cancers), HIV infection, extreme fear of needles, abnormal abdominal conditions like hernias or scars.Check my eligibility
What is being tested?
The study is testing CBL-514 injections against a placebo (0.9% Sodium Chloride) to see if it can reduce belly fat effectively and safely. This Phase 2b trial randomly assigns participants to receive either the real injection or a fake one without knowing which they're getting.See study design
What are the potential side effects?
While specific side effects are not listed here for CBL-514 Injection, common ones for similar treatments include reactions at the injection site such as pain or swelling, nausea, potential allergic reactions and possibly systemic effects depending on how the drug works.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 8 weeks after the final treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 8 weeks after the final treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with at least 1-grade improvement reported by Investigator via photographic evaluation using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)
Secondary outcome measures
Number of treatments required to first occurrence of a CR-AFRS improvement reported by blinded physicians.
Percentage of participant who lose at least 150 mL of subcutaneous fat volume measured by MRI
Percentage of participant who lose at least 20 % of subcutaneous fat thickness compared to baseline measured by MRI
+13 moreOther outcome measures
Incidence of clinically significant abnormal findings
Incidence of treatment-emergent adverse events (TEAEs)
Percentage of participants with at least 1-grade improvement reported by Investigator via live evaluation using CR-AFRS
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBL-514 InjectionExperimental Treatment1 Intervention
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.
Group II: 0.9% Sodium ChloridePlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBL-514 Injection
2022
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
430 Total Patients Enrolled
6 Trials studying Subcutaneous Fat
353 Patients Enrolled for Subcutaneous Fat
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
292 Total Patients Enrolled
3 Trials studying Subcutaneous Fat
245 Patients Enrolled for Subcutaneous Fat
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding and agree to use birth control during the study and for 90 days after.I have or had a hernia near my belly button.My diabetes is not well-controlled, with recent or expected medication changes.I have liver cirrhosis with liver tests more than three times the normal limit.I have no allergies to the study drug or its components, except for food allergies.I have a blood clotting disorder or I'm on blood thinners.I haven't had cancer, except for certain skin cancers, in the last 5 years.I have visible folds of fat or skin on my abdomen when standing.I am a male and agree to use a condom and not donate sperm from the start of the treatment until 90 days after it ends.I haven't used any experimental drugs or devices in the last 3 months.I have kidney problems.I have not used any medication injected under the skin in the treatment area within the last 4 weeks.I am on long-term steroids or immunosuppressants, not including asthma inhalers or topical creams for skin issues.I am between 18 and 64 years old.My doctor has rated my abdominal fat as moderate or severe.My weight has been stable, with less than a 3 kg change, for the last 3 months.I am not on medication that affects CYP1A2 enzymes or could risk my safety in the study.I haven't used weight loss drugs or GLP-1 agonists in the last 6 months.I have undergone specific medical procedures.I have signed the consent form and can follow the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: CBL-514 Injection
- Group 2: 0.9% Sodium Chloride
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this trial restricted to individuals of a certain age?
"This trial is only open to individuals who have attained the age of majority and are under 64 years old."
Answered by AI
Who meets the eligibility criteria for involvement in this research?
"This clinical trial seeks 100 individuals with subcutaneous fat, aged between 18 and 64. To be eligible for the study, patients must meet all of the following criteria: they must identify as male or female; have a BMI ranging from 18.5 to 32kg/m2 and body weight greater than 50 kg at Screening and Day 1; possess abdominal fat graded by an Investigator as Grade 3 (moderate) or 4 (severe); maintain stable bodyweight within 3 kilograms per participant report over three months before screening until end of the study; sustain a consistent lifestyle in terms of exercise, dietary habits and smoking behaviour throughout that period; understand"
Answered by AI
What health risks does CBL-514 Injection pose for people undergoing treatment?
"Given that CBL-514 Injection is in its second clinical trial phase, supporting data on safety exists, but efficacy remains unknown. Thus, we estimate the treatment's security with a score of 2."
Answered by AI
What is the current recruitment number for this experiment?
"Affirmative. Accessible on the clinicaltrials.gov website is evidence that this research study, which was initially listed in May 30th 2023, is actively recruiting patients. At present, 100 individuals are required to be enlisted from a single location."
Answered by AI
Are new participants able to join this clinical trial?
"Affirmative. According to the information published by clinicaltrials.gov, this research study is open for recruitments. It was originally posted on May 30th 2023 and last updated June 5th 2023 with a need of 100 participants from 1 medical site."
Answered by AI
Who else is applying?
What site did they apply to?
Investigational site 1
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
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