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A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized, Placebo-Controlled, Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat

NCT05736107•Caliway Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female, aged 18 years to 64 years old (at Screening), inclusive.
•2. Body mass index (BMI) \> 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
•3. 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.
•4. 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.
•5. 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.
•6. 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.

Exclusion Criteria

•1. 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).
•2. Participant diagnosed with coagulation disorders or who is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements that impede coagulation or platelet aggregation.
•3. 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.
•4. 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.
•5. 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.
•6. 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.
•7. Participant with folding fat or skin on abdomen in standing position.
•8. Participant with severe or very severe abdominal visceral fat assessed by the Investigator using the visceral fat scale.
•9. Participant with ventral abdominal or umbilical hernia or previous repair of same.
+26 more criteria

Locations (1)

Investigational site 1

Pflugerville, Texas, United States

Key Dates

Start Date

May 30, 2023

Primary Completion Date

May 20, 2024

Completion Date

May 20, 2024

Last Updated

July 22, 2024

Enrollment

107

ACTUAL participants

Conditions

Subcutaneous Fat

Interventions

CBL-514 Injection

DRUG

0.9% Sodium Chloride

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat

Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

Combination of Light and Ultrasound to Reduce Abdominal Fat

Diagnostic Ultrasound for Measuring Fat of the Body

Subject Evaluation of a 1064nm Diode Laser/RF

A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers