NCT07526974

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )

A Phase 3, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.

Detailed description

A total of approximately 320 adult participants with moderate or severe abdominal fat at Baseline 1 will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 4 weeks.

Conditions

• Subcutaneous Fat

Interventions

Type	Name	Description
DRUG	CBL-514 Injection	Provided as a ready for use injectable CBL-514 solution
DRUG	0.9% Sodium Chloride	Injectable 0.9% Sodium Chloride solution as placebo

Timeline

• Start date: 2026-10-01
• Primary completion: 2027-08-01
• Completion: 2027-10-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

14 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study