Trial results for ponsegromab in patients with Heart Failure were posted on ClinicalTrials.gov on 2026-03-18. The Phase 2 study did not demonstrate a statistically significant improvement in patient-reported outcomes, such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, when compared to placebo.
Background
Heart Failure is a chronic, progressive condition that affects the ability of the heart to pump blood effectively. It leads to symptoms such as shortness of breath, fatigue, and fluid retention, significantly impacting patients' quality of life.
Trial design
The terminated Phase 2 clinical trial (NCT05492500) investigated ponsegromab in 455 participants with Heart Failure. The study was designed to compare the effects of different doses of ponsegromab (100 mg, 200 mg, 300 mg) against a placebo, administered via subcutaneous injections. Participants were blinded to their treatment assignment. While specific primary endpoints were not detailed in the posted results, key measurements focused on patient-reported outcomes related to heart failure symptoms and quality of life.
Key results
The trial evaluated changes from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 Clinical Summary Score (CSS) and Overall Summary Score (OSS) at Week 22.
- For the KCCQ-23 CSS at Week 22, the least squares mean change from baseline in the placebo group was 7.24 Units on a Scale, compared to 7.56 Units on a Scale for the ponsegromab 300 mg group. The least square mean difference between ponsegromab 300 mg and placebo was 0.31 (90% CI: -2.91 to 3.54), with a one-sided P-value of 0.436.
- Mean changes from baseline in KCCQ-23 CSS for other doses were: ponsegromab 100 mg showed a mean change of 5.57 (Standard Deviation: 23.491), ponsegromab 200 mg showed a mean change of 6.25 (Standard Deviation: 18.179), and ponsegromab 300 mg showed a mean change of 8.31 (Standard Deviation: 19.277). The placebo group had a mean change of 7.21 (Standard Deviation: 17.931).
- For the KCCQ-23 OSS at Week 22, the least squares mean change from baseline in the placebo group was 8.04 Units on a Scale, compared to 7.76 Units on a Scale for the ponsegromab 300 mg group. The least square mean difference between ponsegromab 300 mg and placebo was -0.28 (90% CI: -3.5 to 2.94), with a one-sided P-value of 0.5572.
- Mean changes from baseline in KCCQ-23 OSS for other doses were: ponsegromab 100 mg showed a mean change of 7.22 (Standard Deviation: 22.525), ponsegromab 200 mg showed a mean change of 5.38 (Standard Deviation: 17.262), and ponsegromab 300 mg showed a mean change of 8.23 (Standard Deviation: 20.355). The placebo group had a mean change of 7.91 (Standard Deviation: 17.597).
Additional analyses also showed high one-sided P-values, indicating no statistically significant differences across various comparisons, including odds ratios for other outcomes (e.g., P-value of 0.396 for an Odds Ratio of 1.06; P-value of 0.4114 for an Odds Ratio of 1.05).
What this means
The results from this Phase 2 trial indicate that ponsegromab did not achieve a statistically significant improvement in patient-reported heart failure symptoms or overall quality of life, as measured by the KCCQ-23 CSS and OSS, compared to placebo. The consistently high P-values across various analyses suggest that the observed differences were likely due to chance. The termination of the study further underscores the lack of positive efficacy signals in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05492500, titled "A Study of Ponsegromab in People With Heart Failure," were posted on 2026-03-18 on clinicaltrials.gov.