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Weight Loss

CBL-514

Also known as: CBL514, CBL-514D (Dercum's disease formulation)

Clinical Trials
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Key Facts: CBL-514

Category
Weight Loss
FDA Status
Not FDA Approved
Clinical Status
Phase 3 for abdominal subcutaneous fat reduction (SUPREME-01, NCT07140939, enrolling since August 2026; SUPREME-02, NCT07526974, IND cleared May 2026). Results expected in 2027. Phase 2 combination trial with tirzepatide (CBL-0201WR) cleared by the FDA in 2026. CBL-514D in development for Dercum's disease. Not approved anywhere and not commercially available.
Banned in Sport (WADA)
Not named on the WADA list, but WADA's S0 catch-all bans any substance without human therapeutic approval, which covers it until it is approved. Prohibited at all times.
Administration
Injections into the fat layer of the treated area (subcutaneous)
Typical Dose
No community data
Frequency
See trial schedule
Duration
Up to 4 sessions over about 9 to 12 weeks in trials
Also Known As
CBL514, CBL-514D (Dercum's disease formulation)

How does CBL-514 work?

CBL-514 triggers apoptosis, the cell's own controlled self-destruct program, in adipocytes (fat cells). Caliway's preclinical work reports that it raises caspase 3 and the Bax/Bcl-2 ratio, two markers of the internal apoptosis pathway, in a dose-dependent way. The company reports that nearby fibroblasts, blood vessel cells and nerves are spared. This is different from deoxycholic acid (Kybella), which dissolves fat cell membranes and causes local inflammation. GLP-1 drugs like tirzepatide work the other way around: they shrink fat everywhere by reducing appetite, while CBL-514 removes fat cells in one chosen area.

What does the research show?

The clinical data so far comes mostly from Caliway's own trials and press releases. In the Phase 2b study CBL-0204 (107 adults with moderate-to-severe belly fat, up to 4 treatments 3 weeks apart), 76.7% of the CBL-514 group improved at least one grade on the Abdominal Fat Rating Scale versus 18.9% on placebo, 12 weeks after the last treatment. 32% improved by two grades versus 0% on placebo, and half of the treated group lost at least 150 mL of fat under the skin on MRI. A pooled analysis of the CBL-0204 and CBL-0205 studies, presented at EASD 2026 in 46 people, found visceral fat (the deep fat around the organs) fell 10.9% at week 4 on CBL-514 while it rose 4.6% on placebo. The company says more than 544 people have received CBL-514 across its trials, with mainly mild to moderate injection site reactions. Two Phase 3 trials (SUPREME-01 and SUPREME-02) are running, with results expected in 2027. A Phase 2 trial (CBL-0201WR, about 120 people in the US) tests it together with tirzepatide, aimed at stubborn belly fat and fat regain after GLP-1 treatment. A separate formulation, CBL-514D, is in development for Dercum's disease, a rare condition with painful fatty lumps. Independent, peer-reviewed results are still limited.

Trial Progress:Phase III
Pre
I
II
III
IV
FDA

What doses have been studied?

Human Trials·Phase 2 completed and Phase 3 underway, not approved

Typical Dosingⓘ

Community experience

Common Dose

No community data

Range

See trial schedule

Frequency

See trial schedule

Not available outside clinical trials. Not a peptide: CBL-514 is a small-molecule drug.

Research Dosingⓘ

Scientific studies

Trial treatment schedule, not a recommendation. Given only by investigators in clinical trials.

Doses from Studies

Up to 600 mg per session, up to 4 sessions every 3 weeks

Caliway Phase 2b announcement - CBL-0204 Phase 2b, abdominal subcutaneous fat ↗

Duration

Up to 4 sessions over about 9 to 12 weeks in trials

Administration

Injections into the fat layer of the treated area (subcutaneous)

When and how is CBL-514 taken?

Best Time to Take

Not applicable, given in clinic during trials

Sessions every 3 weeks in trials, up to 4 in total

Food Recommendation

With or without food

Why This Timing?

CBL-514 is only given by investigators in clinical trials as a series of injection sessions into a chosen fat area.

What are the side effects of CBL-514?

Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.

  • ●Injection site reactions (mostly mild to moderate)
  • ●Limited published safety data, mostly company-reported
  • ●No long-term safety data
  • ●Investigational - not approved

References

Research This Peptide Further

Frequently Asked Questions

What does CBL-514 do?

CBL-514 is an injectable fat-reducing drug from Taiwan's Caliway Biopharmaceuticals. It is a small molecule, not a peptide, designed to make fat cells at the injection site self-destruct while leaving skin, nerves and blood vessels alone. It is in Phase 3 trials for reducing belly fat, and a Phase 2 trial is testing it together with tirzepatide. Not approved anywhere.

How does CBL-514 work?

CBL-514 triggers apoptosis, the cell's own controlled self-destruct program, in adipocytes (fat cells). Caliway's preclinical work reports that it raises caspase 3 and the Bax/Bcl-2 ratio, two markers of the internal apoptosis pathway, in a dose-dependent way. The company reports that nearby fibroblasts, blood vessel cells and nerves are spared. This is different from deoxycholic acid (Kybella), which dissolves fat cell membranes and causes local inflammation. GLP-1 drugs like tirzepatide work the other way around: they shrink fat everywhere by reducing appetite, while CBL-514 removes fat cells in one chosen area.

Is CBL-514 FDA approved?

No, CBL-514 is not currently FDA approved. Current status: Phase 3 for abdominal subcutaneous fat reduction (SUPREME-01, NCT07140939, enrolling since August 2026; SUPREME-02, NCT07526974, IND cleared May 2026). Results expected in 2027. Phase 2 combination trial with tirzepatide (CBL-0201WR) cleared by the FDA in 2026. CBL-514D in development for Dercum's disease. Not approved anywhere and not commercially available.

Is CBL-514 banned in sport?

Not named on the WADA list, but WADA's S0 catch-all bans any substance without human therapeutic approval, which covers it until it is approved. Prohibited at all times.

What are the side effects of CBL-514?

Reported side effects include: Injection site reactions (mostly mild to moderate), Limited published safety data, mostly company-reported, No long-term safety data, Investigational - not approved. Individual responses vary based on dosage, duration, and personal health factors.

What is the typical dose of CBL-514?

Community-reported common dose: No community data (See trial schedule). Range: See trial schedule. Administration: Injections into the fat layer of the treated area (subcutaneous). Investigational drug. Not medical advice.

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Weight Loss

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