Caliway Biopharmaceuticals C, TW0006919004

Caliway Biopharmaceuticals stock enters second global Phase 3 trial

Published on 11/06/2026 at 10:55 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Caliway Biopharmaceuticals stock gains a fresh clinical milestone as SUPREME-02 starts enrollment. The Phase 3 study targets abdominal subcutaneous fat reduction.

Clinical program expands globally

SUPREME-02 has begun enrollment as Caliway's second global pivotal Phase 3 trial for CBL-514.
The study is planned for about 320 participants at 30 to 35 sites in the United States and Canada.
Preclinical combination data are scheduled for presentation at ObesityWeek on November 15, 2026.

Caliway Biopharmaceuticals C, TW0006919004, Illustration mit AI erstellt.

Caliway Biopharmaceuticals said on October 29, 2026, that enrollment had begun in SUPREME-02, its second global pivotal Phase 3 trial for investigational drug candidate CBL-514. The announcement broadens the company's late-stage clinical program for abdominal subcutaneous fat reduction.

Second pivotal study gets underway

According to the Caliway Biopharmaceuticals announcement, SUPREME-02 is a randomized, double-blind and placebo-controlled multinational study. It is designed to assess the efficacy, safety and tolerability of CBL-514 in adults with abdominal subcutaneous fat concerns.

The company expects to enroll approximately 320 participants across 30 to 35 sites in the United States and Canada. Patient-reported and clinician-reported abdominal fat assessments will be supplemented by magnetic resonance imaging, giving the trial both subjective and imaging-based measures.

Development calendar adds key dates

SUPREME-02 is intended to complement the ongoing SUPREME-01 study. Caliway said the two pivotal trials are expected to generate clinical evidence for potential future regulatory submissions, but the announcement does not establish regulatory approval or commercial availability.

In parallel, the company continues enrollment in the Phase 2 CBL-0206 study in Taiwan and Australia. Caliway said the regional program is intended to expand clinical data in Asian populations and support future regulatory, commercialization and partnering strategies.

The next visible development milestone is scheduled for November 15, 2026, at ObesityWeek in Washington, D.C. Caliway plans to present preclinical data on CBL-514 combined with semaglutide or eloralintide, focusing on weight reduction and the mitigation of weight regain after treatment discontinuation.