A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat
Caliway Biopharmaceuticals Co., Ltd. · NCT07140939
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 3
- Target enrollment
- 320
- US sites recruiting
- 6
- Study start
- September 1, 2026
- Record last updated
- October 19, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
Being studied: CBL-514 Injection; 0.9% Sodium Chloride
Conditions: Subcutaneous Fat
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Male or female, aged ≥ 18 years old.
- Body mass index (BMI) > 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg.
- Participant has moderate or severe abdominal fat as assessed by the Investigator on the CR-AFRS and by the participant on the PR-AFRS.
- Dissatisfaction with the abdominal fat reported by participant as 'Extremely Dissatisfied', 'Dissatisfied', or 'Slightly dissatisfied'.
- Participant maintained a stable lifestyle.
- Voluntarily signs the Informed Consent Form and is physically and mentally capable of participating in the study, and willing to adhere to study procedures.
Exclusion Criteria
- Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method, or who is currently pregnant or lactating. Male participant who is not willing to commit to using condom consistently and refraining from sperm donation.
- Participant who has coagulation disorders.
- Participant has delayed wound healing or poorly controlled diabetes.
- Participant has active malignancies or is currently being evaluated for a possible malignancy.
- Participant has a history of risk factors for torsade de pointes, currently has any uncontrolled cardiovascular disease, or any clinically significant finding on baseline ECG.
- Participant has a history of peripheral arterial disease or clinically significant venous disease involving the lower extremities.
- Participant has 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 has a visible Panniculus on the abdomen in standing position.
- Participant has severe abdominal visceral fat.
- Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation.
- Participant has undergone the procedures at the treatment area that may affect IP administration.
- Participant with contraindications to MRI imaging.
- Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists.
- Participant is undergoing long-term systemic steroid or immunosuppressive therapy.
- Participant is taking or will take any medication that is known strong inhibitor, inducer or is a sensitative substrate for CYP enzymes, or medication with narrow therapeutic index.
- Participant with a history of hypersensitivity to local anesthesia.
- Participant with known allergies or significant adverse reaction to the IP.
- Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments.
- Participant with any renal impairment.
- Participant has received any investigational product within 3 months.
- Participant considered to be unreliable or incapable of complying with the requirements of the protocol.
Recruiting US locations
Investigational site 1
Encinitas, CA 92024
Investigational site 4
Baton Rouge, LA 70809
Investigational site 5
Hunt Valley, MD 21030
Investigational site 6
Omaha, NE 68144
Investigational site 8
New York, NY 10028
Investigational site 11
Pflugerville, TX 78660
Study contacts (from the official record)
- Candra Chou · +886-2-26971355 · cwcr@caliwaybiopharma.com
Similar studies in California
All healthy volunteers studies in California →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
AstraZeneca
- Location
- Glendale, CA + 1 other US site
- Eligibility basics
- Ages 18–55
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
AstraZeneca
- Location
- Rialto, CA + 1 other US site
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Pfizer
- Location
- Lake Forest, CA + 3 other US sites
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Phase 1 Study of SBS-147 in Healthy Adults
Sparian Biosciences, Inc
- Location
- Cypress, CA
- Eligibility basics
- Ages 18–55