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Phase-3 pivotal trials

GLP-1 clinical trials

The 9 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 β€” Glpverdict editorial illustration
  1. Phase 3 Β· 751 participants Β· 72 weeks

    SURMOUNT-5

    Tirzepatide versus Semaglutide in Adults with Obesity β€” SURMOUNT-5 (phase 3b, open-label)

    βˆ’20.2% on tirzepatide vs βˆ’13.7% on semaglutide at week 72

    Full trial profile

  2. Phase 3 Β· 1,961 participants Β· 68 weeks

    STEP-1

    Semaglutide Treatment Effect in People with Obesity β€” 1

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

    Full trial profile

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

    SURMOUNT-1

    A Study of Tirzepatide in Participants with Obesity or Overweight

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

    Full trial profile

  4. Phase 3 Β· 3,297 participants Β· 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

  5. Phase 3 Β· 17,604 participants Β· 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

  6. Phase 3 Β· 1,879 participants Β· 40 weeks

    SURPASS-2

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

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

    Full trial profile

  7. Phase 3 Β· 3,533 participants Β· 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

  8. Phase 3 Β· 469 participants Β· 52 weeks

    SURMOUNT-OSA

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

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

    Full trial profile

  9. Phase 3 Β· 783 participants Β· 88 weeks

    SURMOUNT-4

    Tirzepatide Maintenance β€” Continued versus Withdrawn

    Continued tirzepatide: additional βˆ’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

GLP-1 Pivotal Clinical Trials: STEP, SURMOUNT, SUSTAIN, SELECT, FLOW