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1st Oct, 2026 12:00 AM
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Novel Injectable Drug Cuts Visceral Fat in Phase 2 Trial

TOPLINE

CBL-514, a first-in-class injection that triggers fat cell death, reduced visceral fat volume by nearly 12% at just week 4 and by roughly 10% at weeks 8-12, even as the visceral fat volume continued to increase in individuals given a placebo over the same time periods, pointing to a potential new option for targeting this especially risky type of fat.

METHODOLOGY

  • CBL-514 is a first-in-class injection that selectively triggers fat cell death. In animal studies, it has been shown to reduce visceral fat, especially when combined with GLP-1 drugs — prompting researchers to investigate whether CBL-514 shrinks visceral fat in humans as well.
  • They assessed the efficacy of CBL-514 by analyzing a subgroup of 40 participants (age range, 36.4-42.4 years; BMI, 22-30) with available MRI data from two phase 2 trials.
  • The participants were injected with up to 600 mg of CBL-514 (n = 23) or placebo (n = 17) into the lower abdomen every 3 weeks for up to 12 weeks. The injection frequency was tapered as the abdominal fat thickness decreased and the injection was stopped once the thickness reached a sufficiently low level.
  • Participants in both groups had a similar baseline visceral fat volume, as measured using AI-assisted MRI scans for consistency and precision.
  • Changes in visceral fat volume were tracked by MRI at week 4 and again at weeks 8-12 (after the last treatment), with both the actual amount lost and the percentage change from baseline being measured.

TAKEAWAY

  • At week 4, the mean visceral fat volume dropped by about 71 mL in participants on CBL-514 but rose by about 31 mL in those on placebo, representing a treatment difference of roughly 102 mL (P = .0002).
  • In terms of percentage change, at week 4, the visceral fat volume decreased by approximately 12% in participants on CBL-514 but increased by nearly 6% in those on placebo (P = .0002).
  • At weeks 8-12, the effect held: The mean visceral fat volume dropped by about 63 mL in participants on CBL-514 but rose by about 78 mL in those on placebo, representing a treatment difference of roughly 141 mL (P = .0021).
  • In terms of percentage change, at weeks 8-12, the visceral fat volume decreased by about 10% in participants on CBL-514 but increased by nearly 12% in those on placebo (P = .0019).

IN PRACTICE

"We expect that patients will be pleased by the cosmetic effects, such as the flatter stomach that can come with subcutaneous fat loss. But it is the reduction in body weight, loss of visceral fat and the improvements in blood pressure, cholesterol and the like that should be associated with this that will be important for health," one of the authors involved in this study commented.

SOURCE

The study was led by Yu-Fang Ling, Caliway Biopharmaceuticals in New Taipei City, Taiwan, and it will be presented at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting in Milan, Italy.

LIMITATIONS

The study abstract did not explicitly report limitations.

DISCLOSURES

Three authors declared being employees and/or shareholders of Caliway Biopharmaceuticals, the developer of CBL-514. Two authors reported having consulting, advisory, or research relationships with numerous companies, including Caliway Biopharmaceuticals.

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This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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