CBL-514 for Subcutaneous Fat

Overseen By Ivy Chen

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Must not be taking: Anticoagulants, Antiplatelets, Steroids, Immunosuppressants

Disqualifiers: Pregnancy, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called CBL-514 to understand how the body absorbs and processes it. Researchers administer CBL-514 as a single injection to healthy volunteers to assess its safety and any side effects. The trial seeks participants with a bit of extra belly fat, easily measurable with a skinfold caliper. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as those that affect blood clotting, certain steroids, and specific drugs that interact with liver enzymes. If you need to use these medications, you should stop at least 2 days before and until 1 day after the study dose.

Is there any evidence suggesting that CBL-514 is likely to be safe for humans?

Research has shown that CBL-514 is generally safe and well-tolerated by patients. Studies have demonstrated its effectiveness in reducing fat without causing serious side effects. Most reported side effects, such as bruising or reactions at the injection site, are mild. Another study confirmed that CBL-514 was safe and well-tolerated, even at different doses. Overall, several studies have indicated a positive safety record for CBL-514, suggesting it is a safe option for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CBL-514 is unique because it is administered directly into the subcutaneous tissue of the abdomen, targeting localized fat deposits. While most treatments for fat reduction involve invasive procedures like liposuction or energy-based devices, CBL-514 offers a non-invasive alternative through multiple small injections. Researchers are excited about this treatment because it has the potential to offer precise fat reduction with minimal downtime, providing a convenient option for those seeking to refine their body contour without surgery.

What evidence suggests that CBL-514 might be an effective treatment for the condition being studied?

Research has shown that CBL-514 can help reduce subcutaneous belly fat. In one study, CBL-514 injections safely and effectively reduced both the amount and thickness of this fat. Another study found that 69.9% of participants lost at least 150mL of belly fat, and 60.9% lost 200mL after using CBL-514. These results suggest that CBL-514 could be a promising option for reducing belly fat. Participants in this trial will receive a single course of treatment with CBL-514 to further evaluate its effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

Inclusion Criteria

Body mass index (BMI) >18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.

Participant has sufficient subcutaneous fat thickness of at least 3.00 cm (30.0 mm) measured by caliper skinfold method around treatment area at Screening and Day 1.

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, including food and drink restrictions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a single course of CBL-514 800 mg administered as multiple subcutaneous injections on the abdomen on Day 1

1 day

1 visit (in-person)

Pharmacokinetic Assessment

Evaluate pharmacokinetic parameters including Cmax, AUC, t1/2, CL/F, and Vz/F with 12 time points on Day 1 and Day 2

2 days

Multiple assessments over 2 days

Follow-up

Participants are monitored for treatment-related adverse events and clinically significant abnormalities in various health parameters

4 weeks

Up to 2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CBL-514

How Is the Trial Designed?

Group I: CBL-514 Experimental Treatment 1 Intervention

All 10 participants enrolled in the study will receive a single course of treatment with CBL-514 800 mg (unit dose: 2.0 mg/cm\^2) on the abdomen (administered as multiple subcutaneous injections) on Day 1 only.

CBL-514 is already approved in European Union, United States for the following indications:

Approved in European Union as CBL-514 for:

• Dercum's disease

Approved in United States as CBL-514 for:

• Dercum's disease

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

11

Recruited

550+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9384315/

A Randomized, Phase IIa Study of CBL-514 Injection on ... Our results show that CBL-514 is safe, well-tolerated, and effectively reduces abdominal subcutaneous fat volume and thickness at multiple doses up to 2.0 mg/cm ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04698642

NCT04698642 | A Study to Evaluate the Safety, Tolerability ... A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat.

3. academic.oup.com academic.oup.com/asj/article/45/6/611/8051634

Efficacy and Safety of CBL-514 Injection in Reducing ... A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06005441

NCT06005441 | A Phase 2b Study to Evaluate the Efficacy ... 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 ...

5. caliwaybiopharma.com caliwaybiopharma.com/en/news-detail/cbl-0202-met-efficacy-endpoints/

Caliway's CBL-514 Achieved Better Efficacy than ... - 69.9% and 60.9% of participants lost at least 150mL and 200mL of abdominal subcutaneous fat in the treated area after CBL-514 treatment. - Compared with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080885/

Efficacy and Safety of CBL-514 Injection in Reducing ... A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.

7. caliwaybiopharma.com caliwaybiopharma.com/en/research/15/

CBL-514-R&D-Caliway Biopharmaceuticals Co., Ltd Side effects such as bruising or local reactions are generally mild. CBL-514's Phase 2 study for moderate to severe cellulite (CBL-0201EFP Phase 2) met all ...

8. firstwordpharma.com firstwordpharma.com/story/5933775

Caliway Announces CBL-514 Second Phase 2b Study ... Overall, the safety and tolerability profiles of CBL-514 demonstrated in the study were favorable and consistent with previous clinical studies ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05632926

A Study to Evaluate the Efficacy and Safety of CBL-514 in ... This Phase 2a study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2.