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

NCT05736107 | Completed Phase 2 FDA Drug

• 1 other identifier: CBL-0204
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  From baseline to 4 weeks, 8 weeks and 12 weeks after the final treatment

• Change in subcutaneous fat compared to baseline

  From baseline to 4 weeks and 12 weeks after the final treatment

Study Arms (2)

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.

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.

Other: 0.9% Sodium Chloride

Interventions

CBL-514 Injection DRUG

Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.

CBL-514 Injection

0.9% Sodium Chloride OTHER

Sodium Chloride (0.9% NaCl) placebo for injection

0.9% Sodium Chloride

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.),

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Investigational site 1

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anne Sheu

  Caliway Biopharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: May 30, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

US (1)