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

Completed · Phase 2 · Has a placebo group

Conditions studied: Subcutaneous Fat

In brief

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.

Key facts

Study ID: NCT04897412
Run by: Caliway Biopharmaceuticals Co., Ltd.
People needed: 75
Starts: 2022-02-14
Expected to finish: 2023-03-22
Last updated by the study team: 2023-04-24

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

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,
Tattoos on the area to be treated.
Subject who has undergone the following procedures:
Previous surgery which caused scar tissues on the anticipated treatment area before Screening or during the study, except laparoscopic surgery and surgery which causes very small scar tissues would be eligible as per Investigator's discretion,
Liposuction to the region to be treated before Screening or during the study,
Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to the region to be treated within 12 months before Screening or during the study.
Using medication which is delivered via subcutaneous injection at the treatment area during the study period.
Subject is on prescription or OTC weight reduction medication or weight reduction programs within 3 months before Screening or during the study.
Subject is undergoing chronic steroid or immunosuppressive therapy, with the exception of oral steroid inhalation indicated for asthma management or topical steroid application for skin conditions that are not directly applied or indirectly affect the treatment area.
Requiring continual use of the following therapeutic agents during the study: terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, etc.), any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk.
If a subject needs to use the above mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used at least for 2 days prior to dosing and until 1 day post-dose.

Where it is running

Investigational site 1 — Chicago, Illinois, United States
Investigational site 2 — Omaha, Nebraska, United States
Investigational site 3 — Nashville, Tennessee, United States
Investigational site 4 — Austin, Texas, United States
Investigational site 5 — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.