A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat.

NCT06005441 | Completed Phase 2 FDA Drug

• 1 other identifier: CBL-0205
• Study Type: interventional
• Target: 173
• 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 compared with CBL-A1 and CBL-A2 for reducing subcutaneous fat.

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo

  Measured by MRI

  From Baseline to 4 weeks after the final treatment

Secondary Outcomes (5)

• Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with CBL-A1 and CBL-A2

  From Baseline to 4 weeks after the final treatment

• Participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)

  From Baseline to 4 weeks after the final treatment

• Participants with at least 2-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)

  From Baseline to 4 weeks after the final treatment

• Participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)

  From Baseline to 4 weeks after the final treatment

• Participants with at least 2-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)

  From Baseline to 4 weeks after the final treatment

Study Arms (4)

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 3 weeks for up to 4 treatments.

Drug: CBL-514 injection

CBL-A1 Injection

EXPERIMENTAL

Participant will receive CBL-A1 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.

Drug: CBL-A1 Injection

CBL-A2 Injection

EXPERIMENTAL

Participant will receive CBL-A2 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.

Drug: CBL-A2 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 4 treatments.

Drug: 0.9% Sodium Chloride

Interventions

CBL-514 injection DRUG

Provided as a ready for use injectable CBL-514 solution

CBL-514 Injection

CBL-A1 Injection DRUG

Provided as a ready for use injectable CBL-A1 solution

CBL-A1 Injection

CBL-A2 Injection DRUG

Provided as a ready for use injectable CBL-A2 solution

CBL-A2 Injection

0.9% Sodium Chloride DRUG

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 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 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 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.
• 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) ≥9%, delayed wound healing, or poorly controlled diabetes 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 at Investigator's discretion.
• Participant with a history of human immunodeficiency virus (HIV)-1 infection or active HIV infection at Screening with positive HIV antigen/antibody combo test.
• Participant with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope or 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.
• 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 and efficacy evaluation.
• Participant who has undergone the following procedures:
• Previous surgery that caused scar tissues on the anticipated treatment area before Screening or during the study.
• Liposuction or abdominoplasty to the region to be treated before Screening or during the study.
• Aesthetic procedure for body contouring or fat reduction 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.

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Investigational Site 1

Omaha, Nebraska, 68144, 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: August 10, 2023
• First Posted: August 22, 2023
• Study Start: November 10, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (1)