CONF-2025-ACC-SOUL-LateBreaker — ACC.25 Late-Breaker: SOUL (Oral Semaglutide CV Outcomes)

[DRAFT — authored 2026-04-19. Conference context web-verified via ACC, Novo Nordisk press release, and coverage outlets 2026-04-19.]

Meeting Metadata

Conference: American College of Cardiology Annual Scientific Session 2025 (ACC.25)
Dates: March 29-31, 2025
Location: Chicago, IL, USA
Session type: Late-Breaking Clinical Trial session

Presentation

Presenter: Darren K. McGuire, MD, MHSc — cardiologist, Professor of Medicine, University of Texas Southwestern Medical Center
Study: SOUL — Oral Semaglutide Cardiovascular Outcomes in High-Risk Type 2 Diabetes
Sponsor: Novo Nordisk
Simultaneous publication: New England Journal of Medicine (see cross-link below)

Key Findings as Presented

n=9,650 adults ≥50 years with type 2 diabetes + established ASCVD and/or CKD at 450 medical centers in 44 countries
Randomized to oral semaglutide 14 mg daily vs. placebo
Primary endpoint (first MACE — CV death, non-fatal MI, non-fatal stroke): 14% relative reduction, HR 0.86 (95% CI 0.77-0.96), P=0.006
All three MACE components contributed to the risk reduction
Benefit preserved in pre-specified SGLT2i-concomitant-use subgroup
First CV outcomes trial to establish CV benefit for an oral GLP-1 receptor agonist

Cross-Link to Full Publication

PMID-40162642 – SOUL Oral Semaglutide CV Outcomes — McGuire DK, Marx N, Mulvagh SL, et al. N Engl J Med. 2025;392(20):2001-2012. doi: 10.1056/NEJMoa2501006.

This CONF note captures the conference-abstract presentation context (timing, venue, presenter, session type). The full evidence is in the PMID note; teachers should cite the PMID for clinical content and this CONF note for "where/when was this first presented" teaching context.

Relevance to Module 5

Lesson 5.2 (Semaglutide Deep Dive — Section 6 Expanded Evidence Base) — SOUL evidence block
Semaglutide profile Evidence Base table and Mechanism Section (Research Area #3 Cardiovascular risk reduction)

Sources

ACC Latest in Cardiology — SOUL Trial page
Novo Nordisk press release (March 29, 2025)
AJMC, Pharmacy Times, Radcliffe CVRM late-breaking-discussion coverage

Orchestrator Notes

CONF note cross-linked to full-publication PMID — not a stand-alone orphan.
Verified 2026-04-19 via ACC official page and Novo Nordisk press release.

CONF-2025-ACC-SOUL-LateBreaker