SUPREME-01 is recruiting after first dosing. A small pooled MRI subgroup suggests visceral-fat reduction; short follow-up, selection and missing intervals prevent firm conclusions about durable metabolic benefit. CBL-514 remains investigational.
A randomized study of 108 adults reports an MRI abdominal-fat change of −20.3% versus +0.1% four weeks after the final treatment. This measured a local depot, not whole-body fat.
20 May 2026 · peer-reviewed randomized phase 2b trial
Study results apply to their own population, dose and analysis. They do not establish a ranking between therapies.
Evidence in the atlas
0 results
Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.
peer-reviewed randomized phase 2b trial · 20 May 2026
Abdominal-fat evidence reaches publication
A randomized study of 108 adults reports an MRI abdominal-fat change of −20.3% versus +0.1% four weeks after the final treatment. This measured a local depot, not whole-body fat.
The trial allowed up to four treatments. The clinician-rated primary analysis had 23/30 responders versus 7/37, rather than all 108 randomized participants. Early discontinuation affected 42/108 (38.9%); injection-site pain affected 38/52 treated participants versus 20/55 placebo recipients. MRI was assessed independently and blinded; clinician ratings were unblinded.
Detailed trial charts have not been added for this program. See its sourced development timeline and research notes.
Biology & identity
Status in this atlas: SUPREME-01 is recruiting after first dosing. A small pooled MRI subgroup suggests visceral-fat reduction; short follow-up, selection and missing intervals prevent firm conclusions about durable metabolic benefit. CBL-514 remains investigational.
Caliway describes CBL-514 as a proprietary small-molecule injectable drug candidate.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
The molecule
Caliway describes CBL-514 as a proprietary small-molecule injectable drug candidate.
Structure not yet verified
Chemical structure not verified
Caliway describes CBL-514 as a proprietary small-molecule injectable drug candidate.
Shown: Investigational small-molecule drug / proprietary formulation
The sponsor source identifies the molecular class but does not provide a verified chemical structure in the reviewed material. The PubChem CBL-514 lookup returned no CID. No structure is inferred from its mechanism or substituted from another fat-reduction drug.
Sponsor end-of-2027 forecast; July 2027 registry primary-completion estimate.
The October 2 conference report forecasts pivotal results by the end of 2027. SUPREME-01 registry primary completion remains July 2027; trial completion is not a promised publication date.
SUPREME-01 is recruiting after first dosing. A small pooled MRI subgroup suggests visceral-fat reduction; short follow-up, selection and missing intervals prevent firm conclusions about durable metabolic benefit. CBL-514 remains investigational. Abdominal subcutaneous fat, visceral fat and body weight are different endpoints. The published Phase 2b study had substantial attrition and unblinded clinician ratings; trial clearance is not marketing approval.
An open-label Phase 2a study enrolled 43 adults and compared three CBL-514 dose groups. Higher-dose groups showed reductions in ultrasound-derived abdominal-fat volume versus baseline; there was no placebo group.
Actual first online publication; the study was conducted February–November 2020. · peer-reviewed open-label phase 2a study Source
A second pivotal trial can proceed
Caliway reports that SUPREME-02 passed the U.S. IND review period on May 18. The planned placebo-controlled study targets approximately 320 participants; clearance permits a trial, not commercial use.
Sponsor-reported event date; disclosed May 22, 2026. · sponsor-reported IND clearance Source
Abdominal-fat evidence reaches publication
A randomized study of 108 adults reports an MRI abdominal-fat change of −20.3% versus +0.1% four weeks after the final treatment. This measured a local depot, not whole-body fat.
Actual first publication; final trial follow-up was May 20, 2024. · peer-reviewed randomized phase 2b trial Source
Tirzepatide combination moves toward human testing
Caliway reports IND clearance for CBL-0201WR, a planned randomized Phase 2 trial of CBL-514 plus tirzepatide in approximately 120 adults. Human prevention of weight regain is not established.
Actual disclosure date; exact clearance day is not provided. · sponsor-reported IND clearance SourceSource
Pivotal enrollment is reported underway
Caliway confirms SUPREME-01 enrollment has begun. Its updated primary endpoint requires a two-grade improvement on both patient and clinician abdominal-fat scales; MRI fat volume becomes a key secondary endpoint.
Sponsor status disclosure, following August 25 announcement; not an exact first-participant date. · sponsor phase 3 development update SourceSource
Dercum pain results
The small phase 2 study reports a 3.1-point versus 1.9-point pain decrease at week 20. Painful lipomas are distinct from cosmetic abdominal fat, visceral fat and cellulite.
SUPREME-01 now lists recruiting, a September 1 actual start and 320 planned participants. Patient/clinician response is primary; MRI fat volume is secondary.
registry update; actual start September 1 · trial-registry update Source
SUPREME-01 enters treatment
Caliway reports the first participant dosed and continued recruitment in the U.S. and Canada. The pivotal study plans 320 participants; no phase 3 results are available.
Announcement date; exact first-dose day is undisclosed. · sponsor development announcement SourceSource
Exploratory human visceral-fat results
A selected pooled subgroup from two phase 2 trials had 40 late-visit MRI assessments. Visceral-fat volume changed −10.45% with CBL-514 versus +11.76% with placebo at 8–12 weeks. These are within-group percentage changes, not clinical-event outcomes.
September 30 presentation reported in the sponsor’s October 2 release. · sponsor-reported exploratory human subgroup Source
Await larger blinded comparisons
The October 2 conference report forecasts pivotal results by the end of 2027. SUPREME-01 registry primary completion remains July 2027; trial completion is not a promised publication date.
The open-label Stage 2 CBL-0206 retreatment study estimates primary completion in February 2028. It plans approximately 250 participants and MRI follow-up; this does not yet establish durable benefit.
Estimated primary completion in the May 29 registry record; not a publication date. · planned phase 2 retreatment assessment Source