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SURPASS-T1D-1NCT06914895

A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 20 versions: 19 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: May 2027 to Nov 2026
    • Study completion date: May 2027 to Dec 2026
    • Site details revised at 146 of 146 sites
    v19
  2. Minor Site details revised at 64 of 146 sitesv18
  3. Minor Site details revised at 1 of 146 sitesv17
  4. Minor Site details revised at 18 of 146 sitesv16
  5. Minor Study sites: 147 to 146v15
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Site details revised at 1 of 147 sitesv14
  2. Minor Site contacts updated at 1 of 147 sitesv13
  3. Minor Site details revised at 1 of 147 sitesv12
  4. Minor Site details revised at 14 of 147 sitesv11
  5. Minor Study sites: 148 to 147v10
  6. Minor Site details revised at 7 of 148 sitesv9
  7. Minor Site details revised at 99 of 148 sitesv8
  8. Minor Study sites revised (148)v7
  9. Minor Site details revised at 9 of 148 sitesv6
  10. Minor Site details revised at 41 of 148 sitesv5
  11. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2025 to Apr 25, 2025
    • Site details revised at 148 of 148 sites
    v4
  12. Minor Site details revised at 148 of 148 sitesv3
  13. Study Status, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from Baseline in Hemoglobin A1c (HbA1c)
Timeframe: Baseline, Week 40

Secondary (13)

Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L) Inclusive, Per Day
Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight
Percentage of Participants with ≥5% Body Weight Reduction
Percentage of Participants with ≥10% Body Weight Reduction
Show 8 moreShow less
Percentage of Participants with ≥15% Body Weight Reduction
Change from Baseline in Waist Circumference
Change from Baseline in Systolic Blood Pressure (SBP)
Percent Change from Baseline in Fasting Triglycerides
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol
Percent Change from Baseline in Total Daily Insulin Dose
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Change from Baseline in EQ-5D-5L

Arms and interventions

Tirzepatide Dose 1Experimental

Participants will receive tirzepatide subcutaneously (SC)

Tirzepatide Dose 2Experimental

Participants will receive tirzepatide SC

Tirzepatide Dose 3Experimental

Participants will receive tirzepatide SC

Tirzepatide Dose 4Experimental

Participants will receive tirzepatide SC

PlaceboPlacebo comparator

Participants will receive placebo SC

Drugs: Tirzepatide, Placebo

Sites

146 sites in 12 countries

United States 31, Japan 29, France 13, Argentina 12, Brazil 10, Israel 10, Germany 9, Mexico 9, Italy 8, Spain 8, Denmark 5, Puerto Rico 2