CONFIDENTIAL — PRE-PUBLICATION / EMBARGOED
SYNTHETIC DATA — FABRICATED FOR DEMONSTRATION ONLY. NOT REAL TRIAL DATA. DO NOT CITE.

Sponsor: Meridian Therapeutics (fictional)
Study ID: MER-T2D-301 ("HORIZON-T2D")
Compound: semaglutide (investigational extended-dose regimen)
Indication: type 2 diabetes mellitus with established cardiovascular disease
Status: Topline results — EMBARGOED until primary manuscript publication. Internal value-evidence use only.

STUDY DESIGN
Phase 3, randomized, double-blind, placebo-controlled, multinational trial.
N = 2,148 adults with inadequately controlled type 2 diabetes (baseline HbA1c 7.5–10.5%)
and established atherosclerotic cardiovascular disease. Randomized 1:1 to investigational
extended-dose semaglutide versus placebo, on top of standard of care. Median follow-up 104 weeks.

PRIMARY ENDPOINT — HbA1c change from baseline at week 52
  Treatment:            -1.8% (95% CI -1.9 to -1.7)
  Placebo:              -0.3% (95% CI -0.4 to -0.2)
  Treatment difference: -1.5% (p < 0.001)

KEY SECONDARY ENDPOINTS
  Body weight change at week 52:        -11.2 kg vs -1.4 kg (difference -9.8 kg, p < 0.001)
  3-point MACE (CV death, nonfatal MI,
    nonfatal stroke):                   HR 0.74 (95% CI 0.61–0.90, p = 0.003)
  Patients achieving HbA1c < 7.0%:      68% vs 21%

SAFETY
  Gastrointestinal AEs (nausea, vomiting, diarrhea): 41% vs 16%; mostly mild-to-moderate and transient.
  Serious adverse events:                            9.1% vs 9.8% (no significant difference).
  No new safety signals. Pancreatitis and medullary thyroid events low and balanced across arms.

EMBARGO NOTICE
These results are unpublished and under embargo. Do not disclose, quote, or share externally
until the primary manuscript is published. This document is fabricated synthetic data created
solely to demonstrate confidential-document handling and contains no real patient or trial information.