Pacibekitug, a novel, long-acting monoclonal antibody that targets interleukin-6, produced sustained reductions in inflammatory markers in patients with chronic kidney disease (CKD) and at high inflammatory risk, with no clear dose-related safety signals identified, based on findings from the TRANQUILITY study presented at ESC Congress 2026.

Researchers for the phase II study conducted at 49 centers in the U.S., randomized (1:1:1:1) at total of 143 patients with stage 3-4 CKD and elevated high-sensitivity C-reactive protein (hs-CRP) to receive subcutaneous pacibekitug at doses of 25 mg every 90 days; 50 mg every 90 days; 15 mg every 30 days; or placebo for six months. The mean age of study participants was 69 years and 64% were women. Roughly 70% were on statins and 60% had diabetes.

Overall results showed pacibekitug treatment resulted in dose-dependent decreases in hs-CRP by day 30, which were sustained through day 180. Deepak Bhatt, MD, MPH, MBA, FACC, from the Icahn School of Medicine at Mount Sinai in New York, reported that median time-averaged change from baseline in hs-CRP through day 180 was +7% with placebo; −76% with pacibekitug 25 mg every 90 days; −85% with pacibekitug 50 mg every 90 days; and −89% with pacibekitug 15 mg every 30 days (all p<0.0001 vs. placebo).

In other findings, researchers saw sustained reductions in other inflammatory markers, as well as fibrinogen and lipoprotein(a) across all of the pacibekitug groups compared with placebo. Additionally, no clear dose-related safety signals were observed and only 2% of those receiving pacibekitug discontinued its use.

“Results from the TRANQUILITY study demonstrate that the IL-6 pathway can be durably suppressed with infrequent dosing and no new safety signals,” said Bhatt. “The next step is to determine whether the biomarker eHects observed in TRANQUILITY translate into improved cardiovascular outcomes for patients in a larger, longer-term phase III trial.”

Visit ACC’s ESC Congress 2026 coverage page to explore the latest science and key takeaways shaping cardiovascular care.

Clinical Topics: Novel Agents

Keywords: ESC Congress, ESC26, Kidney Diseases, Chronic Kidney Disease, Cardiovascular Diseases, Interleukin-6, Antibodies, Monoclonal