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Phase-3 pivotal trials

GLP-1 clinical trials

The 8 pivotal phase-3 trials that established GLP-1 efficacy + safety. Each page renders a full MedicalStudy JSON-LD record + primary publication link + clinical takeaways.

GLP-1 clinical trials — Glpverdict editorial illustration
  1. Phase 3 · 1,961 participants · 68 weeks

    STEP-1

    Semaglutide Treatment Effect in People with Obesity — 1

    −14.9% mean body-weight reduction on semaglutide vs −2.4% placebo (P<0.001)

    Full trial profile

  2. Phase 3 · 2,539 participants · 72 weeks

    SURMOUNT-1

    A Study of Tirzepatide in Participants with Obesity or Overweight

    −15.0% (5 mg), −19.5% (10 mg), −20.9% (15 mg) on tirzepatide vs −3.1% placebo

    Full trial profile

  3. Phase 3 · 3,297 participants · 104 weeks

    SUSTAIN-6

    Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes

    26% relative reduction in MACE on semaglutide vs placebo (HR 0.74, 95% CI 0.58-0.95; P=0.02 for non-inferiority and superiority)

    Full trial profile

  4. Phase 3 · 17,604 participants · 197 weeks

    SELECT

    Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity

    20% relative reduction in MACE on semaglutide 2.4 mg vs placebo (HR 0.80, 95% CI 0.72-0.90; P<0.001)

    Full trial profile

  5. Phase 3 · 1,879 participants · 40 weeks

    SURPASS-2

    A Study of Tirzepatide versus Semaglutide in Participants with Type 2 Diabetes

    Tirzepatide superior at all three doses: −2.01% (5 mg), −2.24% (10 mg), −2.30% (15 mg) vs −1.86% semaglutide 1 mg

    Full trial profile

  6. Phase 3 · 3,533 participants · 170 weeks

    FLOW

    A Research Study to See How Semaglutide Works Compared to Placebo in People with Type 2 Diabetes and Chronic Kidney Disease

    24% relative reduction in primary composite on semaglutide vs placebo (HR 0.76, 95% CI 0.66-0.88; P<0.001)

    Full trial profile

  7. Phase 3 · 469 participants · 52 weeks

    SURMOUNT-OSA

    A Study of Tirzepatide in Adults with Obesity and Moderate-to-Severe Obstructive Sleep Apnea

    −25 to −29 events/hour mean reduction on tirzepatide vs −5 events/hour placebo

    Full trial profile

  8. Phase 3 · 783 participants · 88 weeks

    SURMOUNT-4

    Tirzepatide Maintenance — Continued versus Withdrawn

    Continued tirzepatide: additional −5.5% weight loss. Withdrawn to placebo: regained 14% of body weight by week 88 (about 2/3 of weight previously lost).

    Full trial profile