Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT03730662 SURPASS-4 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) Baseline, Week 52 | 10 mg Tirzepatide | -2.43 Percentage of HbA1c (±0.053 Standard Error) |
| 15 mg Tirzepatide | -2.58 Percentage of HbA1c (±0.053 Standard Error) | |||
| Insulin Glargine | -1.44 Percentage of HbA1c (±0.030 Standard Error) | |||
| NCT03861039 | Diabetes Mellitus, Type 2 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Baseline through Week 52 | 10 mg Tirzepatide | 1 Participants |
| 15 mg Tirzepatide | 1 Participants | |||
| 5 mg Tirzepatide | 0 Participants | |||
| NCT03861052 SURPASS J-mono | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 52 | 0.75 mg Dulaglutide | -1.29 percentage of HbA1c (±0.065 Standard Error) |
| 10 mg Tirzepatide | -2.55 percentage of HbA1c (±0.067 Standard Error) | |||
| 15 mg Tirzepatide | -2.82 percentage of HbA1c (±0.066 Standard Error) | |||
| 5 mg Tirzepatide | -2.37 percentage of HbA1c (±0.066 Standard Error) | |||
| NCT03882970 SURPASS-3 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) Baseline, Week 52 | 10 mg Tirzepatide | -2.20 Percentage of HbA1c (±0.051 Standard Error) |
| 15 mg Tirzepatide | -2.37 Percentage of HbA1c (±0.050 Standard Error) | |||
| Insulin Degludec | -1.34 Percentage of HbA1c (±0.049 Standard Error) | |||
| NCT03954834 SURPASS-1 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40 | 10 mg Tirzepatide | -1.89 Percentage of HbA1c (±0.096 Standard Error) |
| 15 mg Tirzepatide | -2.07 Percentage of HbA1c (±0.098 Standard Error) | |||
| 5 mg Tirzepatide | -1.87 Percentage of HbA1c (±0.094 Standard Error) | |||
| Placebo | 0.04 Percentage of HbA1c (±0.105 Standard Error) | |||
| NCT03987919 SURPASS-2 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) Baseline, Week 40 | 1 mg Semaglutide | -1.86 Percentage of HbA1c (±0.048 Standard Error) |
| 10 mg Tirzepatide | -2.37 Percentage of HbA1c (±0.048 Standard Error) | |||
| 15 mg Tirzepatide | -2.46 Percentage of HbA1c (±0.048 Standard Error) | |||
| NCT04039503 SURPASS-5 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) Baseline, Week 40 | 10 mg Tirzepatide | -2.59 Percentage of HbA1c (±0.081 Standard Error) |
| 15 mg Tirzepatide | -2.59 Percentage of HbA1c (±0.083 Standard Error) | |||
| Placebo | -0.93 Percentage of HbA1c (±0.079 Standard Error) | |||
| NCT04093752 | Diabetes Mellitus, Type 2 | Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) Baseline, Week 40 | 10 mg Tirzepatide | -2.44 Percentage of HbA1c (±0.073 Standard Error) |
| 15 mg Tirzepatide | -2.49 Percentage of HbA1c (±0.072 Standard Error) | |||
| Insulin Glargine | -0.95 Percentage of HbA1c (±0.073 Standard Error) | |||
| NCT04184622 SURMOUNT-1 | Obesity | Percent Change From Baseline in Body Weight (Primary Treatment Period) Baseline, Week 72 | 10 mg Tirzepatide | -21.4 percent change (±0.39 Standard Error) |
| 15 mg Tirzepatide | -22.5 percent change (±0.39 Standard Error) | |||
| 5 mg Tirzepatide | -16.0 percent change (±0.39 Standard Error) | |||
| Placebo | -2.4 percent change (±0.40 Standard Error) | |||
| NCT04184622 SURMOUNT-1 | Obesity | Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) Week 72 | 10 mg Tirzepatide | 96.18 Percentage of Participants |
| 15 mg Tirzepatide | 96.32 Percentage of Participants | |||
| 5 mg Tirzepatide | 89.41 Percentage of Participants | |||
| Placebo | 27.87 Percentage of Participants | |||
| NCT04537923 SURPASS-6 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 52 | Insulin Lispro | -1.16 Percentage of HbA1c (±0.049 Standard Error) |
| Pooled 5 mg/10 mg/15 mg Tirzepatide | -2.26 Percentage of HbA1c (±0.048 Standard Error) | |||
| NCT04657003 SURMOUNT-2 | Obesity | Percent Change From Baseline in Body Weight Baseline, Week 72 | 10 mg Tirzepatide | -13.4 percent change (±0.48 Standard Error) |
| 15 mg Tirzepatide | -15.7 percent change (±0.49 Standard Error) | |||
| Placebo | -3.3 percent change (±0.49 Standard Error) | |||
| NCT04657003 SURMOUNT-2 | Obesity | Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline Week 72 | 10 mg Tirzepatide | 81.55 percentage of participants |
| 15 mg Tirzepatide | 86.41 percentage of participants | |||
| Placebo | 30.55 percentage of participants | |||
| NCT04657016 SURMOUNT-3 | Obesity | Percent Change From Baseline in Body Weight Baseline, 72 Weeks | Placebo | 3.3 Percent change (±0.60 Standard Error) |
| Tirzepatide | -21.1 Percent change (±0.59 Standard Error) | |||
| NCT04657016 SURMOUNT-3 | Obesity | Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction Week 72 | Placebo | 10.65 percentage of participants |
| Tirzepatide | 94.37 percentage of participants | |||
| NCT04660643 SURMOUNT-4 | Obesity | Percent Change From Randomization in Body Weight at Week 88 Randomization (Week 36), Week 88 | Placebo | 14.8 percent change (±0.53 Standard Error) |
| Tirzepatide MTD | -6.7 percent change (±0.52 Standard Error) | |||
| NCT04844918 SURMOUNT-J | Obesity | Mean Percent Change in Body Weight Baseline, 72 Weeks | 10 mg Tirzepatide | -17.8 Percent change (±0.94 Standard Error) |
| 15 mg Tirzepatide | -22.7 Percent change (±0.90 Standard Error) | |||
| Placebo | -1.7 Percent change (±0.90 Standard Error) | |||
| NCT04844918 SURMOUNT-J | Obesity | Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 72 | 10 mg Tirzepatide | 94.37 Percentage of participants |
| 15 mg Tirzepatide | 96.05 Percentage of participants | |||
| Placebo | 20 Percentage of participants | |||
| NCT04847557 | Obesity | Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Baseline, Week 52 | Placebo | 12.68 Score on a scale (±1.25 Standard Error) |
| Tirzepatide - MTD | 19.51 Score on a scale (±1.24 Standard Error) | |||
| NCT04847557 | Obesity | First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes Baseline Up To 160 weeks | Placebo | 56 Number of events |
| Tirzepatide - MTD | 36 Number of events | |||
| NCT05024032 SURMOUNT-CN | Obesity | Mean Percent Change From Baseline in Body Weight Baseline, Week 52 | 10 mg Tirzepatide | -14.4 Percent change (±0.98 Standard Error) |
| 15 mg Tirzepatide | -19.9 Percent change (±1.01 Standard Error) | |||
| Placebo | -2.4 Percent change (±1.00 Standard Error) | |||
| NCT05024032 SURMOUNT-CN | Obesity | Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 52 | 10 mg Tirzepatide | 91.43 Percentage of participants |
| 15 mg Tirzepatide | 92.65 Percentage of participants | |||
| Placebo | 29.41 Percentage of participants | |||
| NCT05260021 SURPASS-PEDS | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) Baseline, Week 30 | Placebo | -0.23 percentage of HbA1c (±0.229 Standard Error) |
| Pooled Doses of Tirzepatide (5 mg, 10 mg) | -2.03 percentage of HbA1c (±0.165 Standard Error) | |||
| NCT05412004 SURMOUNT-OSA | Obesity | Change From Baseline in Apnea-Hypopnea Index (AHI) Baseline, Week 52 | Placebo_GPI1 | -5.25 events per hour (±2.11 Standard Error) |
| Placebo_GPI2 | -5.51 events per hour (±2.21 Standard Error) | |||
| Tirzepatide MTD_GPI1 | -25.25 events per hour (±2.06 Standard Error) | |||
| Tirzepatide MTD_GPI2 | -29.27 events per hour (±1.99 Standard Error) | |||
| NCT05691712 SURPASS-CN-INS | Diabetes Mellitus, Type 2 | Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg]) Baseline, Week 40 | 10 mg Tirzepatide | -26.1 millimoles per mole (mmol/mol) (±1.367 Standard Error) |
| 15 mg Tirzepatide | -25.9 millimoles per mole (mmol/mol) (±1.386 Standard Error) | |||
| Placebo | -9.96 millimoles per mole (mmol/mol) (±1.340 Standard Error) | |||
| NCT05822830 SURMOUNT-5 | Obesity | Percent Change From Baseline in Body Weight Baseline, Week 72 | 15 mg or MTD - Tirzepatide | -20.2 Percent change (±0.59 Standard Error) |
| 2.4 mg or MTD - Semaglutide | -13.7 Percent change (±0.59 Standard Error) | |||
| NCT05963022 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40 | 10 mg Tirzepatide | -1.75 percentage of HbA1c (±0.131 Standard Error) |
| 15 mg Tirzepatide | -2.03 percentage of HbA1c (±0.124 Standard Error) | |||
| 5 mg Tirzepatide | -2.19 percentage of HbA1c (±0.121 Standard Error) | |||
| Placebo | -0.77 percentage of HbA1c (±0.126 Standard Error) |