A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)

NCT04897412 | Completed Phase 2 FDA Drug

• 1 other identifier: CBL-0202(Stage 2)
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  From Visit 2 (Baseline) up to 8 weeks after last treatment

• Change of subcutaneous fat volume over the treated area compared with placebo

  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

  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

  Up to 8 weeks after last treatment

Study Arms (2)

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.

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.

Other: Placebo

Interventions

CBL-514 Injection DRUG

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

CBL-514 Injection

Placebo OTHER

Sodium Chloride (0.9% NaCl) placebo for injection

Placebo: 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) 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.

You may not qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Caliway Biopharmaceuticals Co., Ltd.: lead

Study Sites (5)

Investigational site 1

Chicago, Illinois, 60611, United States

Location

Investigational site 2

Omaha, Nebraska, 68144, United States

Location

Investigational site 3

Nashville, Tennessee, 37215, United States

Location

Investigational site 4

Austin, Texas, 78759, United States

Location

Investigational site 5

Melbourne, Victoria, 3141, Australia

Location

Study Officials

• Anne Sheu

  Caliway Biopharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: February 14, 2022
• Primary Completion: February 22, 2023
• Study Completion: March 22, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

US (4); AU (1)