CBL-514 SUPREME-01 and SUPREME-02: what Phase 3 status means

The SUPREME-01 record, NCT07140939, identifies protocol CBL-0301 as a randomized, placebo-controlled Phase 3 study of abdominal subcutaneous fat. It lists 320 planned participants, an actual start on 1 September 2026 and recruiting status. The SUPREME-02 record, NCT07526974, identifies CBL-0302 as a separate Phase 3 study with 320 planned participants. Both registries describe masking of participants, investigators and outcome assessors. Estimated enrollment is a target, not a count of people already treated.

The registry pages are living records with posted update dates. On 31 October 2026, SUPREME-01’s last update was posted 19 October and SUPREME-02’s on 20 October. The second record still displayed “not yet recruiting,” although Caliway announced on 29 October that SUPREME-02 enrollment had begun. The most direct reading is a dated source difference; the later announcement does not retroactively change the earlier registry snapshot. Recheck both before quoting current recruitment status.

No. The SUPREME-01 record describes the percentage achieving at least a two-grade improvement on both the patient-reported and clinician-reported Abdominal Fat Rating Scales against placebo, measured four weeks after final treatment. MRI percentage change is listed as a secondary outcome. The SUPREME-02 record describes at least a two-grade patient-reported scale improvement together with a clinically meaningful abdominal-fat reduction, using the scale and MRI. It also lists MRI percentage change separately as a secondary measure.

These registry descriptions are not outcome data. They tell readers what the studies intend to measure, and the precise wording may change in later protocol updates. A 2026 Phase 2b publication used at least one-grade clinician improvement as its primary endpoint; that earlier threshold cannot be inserted into the Phase 3 headline. Read the full current record, protocol and eventual statistical report before making cross-trial numerical comparisons. The measurement guide explains why grades and MRI volume are different units.

A first participant dosed in SUPREME-01, reported by Caliway on 23 September, establishes that treatment began in that trial. A 29 October recruitment announcement for SUPREME-02 marks an operational milestone. Neither statement supplies a Phase 3 efficacy estimate, completed safety follow-up or a regulator’s marketing decision. The registry lists estimated primary-completion months in 2027; those are planning dates and may change.

Caliway’s 30 October clarification says its investigational CBL-514 is not commercially available and no third party is authorized to sell it. That status remains separate from Phase 3 enrollment. If a search snippet claims Phase 3 “approval,” ask which authority approved what: a clinical trial may proceed under oversight while the drug itself remains unapproved for marketing. This page records the studies’ public status as of 31 October 2026 and links the source records for later rechecking.