Allurion Reports 23% Weight Loss and 14% Lean Mass Gain in 12‑Month Tirzepatide Combination Study

ALUR
November 25, 2025

Allurion Technologies disclosed that a 12‑month case series of 76 patients who received the swallowable Allurion Smart Capsule followed by low‑dose tirzepatide achieved an average total body weight loss of 23 % and a 14 % increase in lean body mass, with 100 % adherence to the tirzepatide regimen.

The protocol began with 45 days of balloon therapy, after which patients started tirzepatide at 2.5 mg, titrated to no more than 5 mg over the next two months. Tirzepatide was then continued for eight months, and final measurements were taken two months after discontinuation, providing a 12‑month follow‑up period.

These results suggest that combining the Allurion Program with a GLP‑1 agent can deliver substantial weight loss while preserving muscle mass—a challenge that has limited the effectiveness of higher‑dose GLP‑1 monotherapy. The 100 % medication adherence rate indicates that lower dosing may reduce the discontinuation rates that have plagued current GLP‑1 therapies, positioning the combination as a potentially more sustainable treatment option.

Allurion has faced revenue declines and is actively restructuring to reduce operating expenses, but the positive clinical data support the company’s strategy to launch a combined therapy in the United States. The company plans to validate these findings in a prospective clinical trial, which could accelerate regulatory approval and broaden its market reach.

Dr. Luigi Flagiello, Allurion’s Chief Medical Officer, said the study “demonstrates the synergistic effect of the Smart Capsule and low‑dose tirzepatide, showing that we can achieve significant weight loss while maintaining muscle mass and achieving perfect adherence.” He added that the data “support our strategy to pursue FDA approval for the combined therapy and could accelerate market penetration.”

Analysts remain positive on the clinical data, noting that the study addresses key limitations of GLP‑1 therapies. However, investors are cautious due to Allurion’s recent financial headwinds, and the company’s stock remains near its 52‑week low. The market is watching closely for the outcome of the planned prospective trial and the company’s progress toward regulatory approval.

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