SignalTrace

SURPASS-1

John Montgomery2 min read

SURPASS-1

SURPASS-1 was the first of the six Phase 3 SURPASS trials and tested tirzepatide as monotherapy in patients with Type 2 diabetes inadequately controlled by diet and exercise alone, with no prior injectable therapy. It was the cleanest test of tirzepatide’s intrinsic glucose-lowering and weight-loss effects, without the confound of background injectable therapy. The trial ran for 40 weeks at 52 medical research centres and hospitals in India, Japan, Mexico, and the USA.

Ontology SURPASS-1 [part-of] SURPASS Clinical Trial Programme SURPASS-1 [studied_in] Tirzepatide SURPASS-1 [measured_by] HbA1c Reduction SURPASS-1 [relates] Type 2 Diabetes SURPASS-1 [compared_against] Placebo

Key Results

  • HbA1c change from baseline: −1.87% (5mg), −1.89% (10mg), −2.07% (15mg) vs +0.04% (placebo) — all p<0.0001
  • Treatment difference vs placebo: −1.91% (5mg), −1.93% (10mg), −2.11% (15mg)
  • HbA1c <7.0%: 87% (5mg), 90% (10mg), 92% (15mg) vs 20% (placebo)
  • HbA1c ≤6.5%: 81–86% vs 10% (placebo)
  • HbA1c <5.7% (near-normoglycaemia): 31% (5mg), 40% (10mg), 52% (15mg) vs 1% (placebo)
  • Body weight: −7.0 kg (5mg), −7.8 kg (10mg), −9.5 kg (15mg) vs −0.7 kg (placebo)
  • Hypoglycaemia (<54 mg/dL or severe): None reported with tirzepatide; 0 in placebo
  • Nausea: 12% (5mg), 16% (10mg), 18% (15mg) vs 6% (placebo)
  • Diarrhoea: 12–14% vs 8%
  • Vomiting: 2–6% vs 2%
  • Discontinuation: 14% study drug; 10% study prematurely
  • Deaths: 1 (placebo group)

Limitations

  • Trial design: Only 40 weeks — no long-term durability data
  • Population: Injection-naive, relatively early disease (mean diabetes duration 4.7 years), overweight/obese (BMI 31.9), mean HbA1c 7.9% — may not reflect advanced or long-standing T2D
  • Duration: Short for assessing durability of effect; no washout data
  • Sponsorship: Funded by Eli Lilly; all named authors with financial ties to industry

Connections

Sources

Graph View

Backlinks