CBL-514

In plain language

CBL-514 is an experimental small-molecule injection developed by Caliway to reduce fat beneath the skin in a treated area. It is not a peptide and should not be presented as the same type of medicine as tirzepatide. (Caliway product overview, FDA description of tirzepatide)

Caliway proposes that CBL-514 works by promoting the programmed death of fat cells, a process called adipocyte apoptosis. This is the developer’s description of the intended mechanism, not proof that every treated person will benefit or that long-term safety has been established. (Caliway product overview, published Phase 2 study)

For students

Subcutaneous fat sits beneath the skin; it is different from visceral fat deeper inside the abdomen. SUPREME-01 is studying localized abdominal subcutaneous fat reduction, rather than establishing CBL-514 as a general-purpose weight-loss treatment. (SUPREME-01 trial record)

The SUPREME-01 record, NCT07140939, lists a randomized, blinded, placebo-controlled Phase 3 study with an estimated enrollment of 320 adults and locations in the United States and Canada. The record reviewed for this profile lists the study as recruiting and does not post study results; a registry status does not guarantee that a particular site is currently accepting participants. (SUPREME-01 trial record)

A separate planned Phase 2 study, CBL-0201WR, would test CBL-514 together with tirzepatide in an anticipated 120 participants in the United States. Caliway’s August 25, 2026 announcement reports clearance of that study’s Investigational New Drug application, not clinical results from the combination. (Caliway trial-development announcement)

Evidence and limitations

A published randomized Phase 2 study enrolled 76 participants into CBL-514 or placebo groups and reported a greater proportion reaching its localized fat-volume-reduction endpoint with CBL-514. However, the trial was single-blind, only 38 of 75 treated participants completed the study, and follow-up extended only eight weeks after final treatment. (published Phase 2 study)

Injection-site reactions were common, and severe injection-site pain occurred in some participants. These findings should not be reduced to a blanket claim that CBL-514 is painless, risk-free or proven safe for long-term use. (published Phase 2 study)

A separate Phase 2b paper published online in May 2026 reports clinician-rated, participant-rated and MRI findings for abdominal fat reduction. It is earlier-phase evidence, not a result from SUPREME-01. (Phase 2b publication)

Caliway funded the earlier Phase 2 study and participated in its design, analysis and publication; several authors disclosed company employment or other relationships. Sponsor involvement does not automatically invalidate a study, but readers should know about it when interpreting the evidence. (published study funding and disclosures)