CompletedPhase 2

A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)

Australia25 participantsStarted 2020-12-09

Plain-language summary

The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study. The primary objectives are to evaluate the safety and tolerability of injection lipolysis with CBL-514. It will be followed by a parallel-arm multiple-dose design in Stage 2.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Body mass index (BMI) \>18.5 and \<32 kg/m2 and body weight ≥50 kg at Screening and Day 1.
. Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm (15.0 mm) and up to 5.00 cm (50.0 mm) measured by ultrasound, surrounding the center of treatment area at Screening and Day 1.
. Subject has stable body weight (identified as ≤ 5% weight change) 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) 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Treatment Emergent Adverse Events

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Physical Examination

Timeframe: Up to 4 weeks after treatment

Number of Participants With Injection Site Reactions

Timeframe: Up to 4 weeks after treatment

Trial details

NCT IDNCT04575467

SponsorCaliway Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-15

Results submitted2024-02-22

View on ClinicalTrials.gov More Subcutaneous Fat trials

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Body mass index (BMI) \>18.5 and \<32 kg/m2 and body weight ≥50 kg at Screening and Day 1.
. Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm (15.0 mm) and up to 5.00 cm (50.0 mm) measured by ultrasound, surrounding the center of treatment area at Screening and Day 1.
. Subject has stable body weight (identified as ≤ 5% weight change) 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) 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.

Exclusion criteria

What they're measuring

Number of Treatment Emergent Adverse Events

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

Timeframe: Up to 4 weeks after treatment

Number of Participants With Clinically Significant Abnormalities in Physical Examination

Timeframe: Up to 4 weeks after treatment

Number of Participants With Injection Site Reactions

Timeframe: Up to 4 weeks after treatment