Primary outcome
What SURPASS-1 measured first
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=118 | 15 mg Tirzepatiden=116 | Placebon=112 |
|---|---|---|---|
| -1.87(0.094) | -1.89(0.096) | -2.07(0.098) | 0.04(0.105) |
Phase 3 · Tirzepatide
SURPASS-1 trial results
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Change From Baseline in Hemoglobin A1c (HbA1c) (Percentage of HbA1c), Baseline, Week 40. 5 mg Tirzepatide: -1.87; 10 mg Tirzepatide: -1.89; 15 mg Tirzepatide: -2.07; Placebo: 0.04.
- Participants
- 478
- Status
- completed
- Completed
- 2020-10-28
- Sponsor
- Eli Lilly and Company
As posted on ClinicalTrials.gov (NCT03954834), updated at source Oct 20, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in SURPASS-1
Percent of participants affected, Baseline to end of Safety follow-up (up to 44 weeks). The most common events the registry lists.
| Event | 5 mg Tirzepatide | 10 mg Tirzepatide | 15 mg Tirzepatide | Placebo |
|---|---|---|---|---|
| Any serious event | 4.1% | 1.7% | 0.8% | 2.6% |
| Hyperglycaemia | 3.3% | 4.1% | 2.5% | 27% |
| Nausea | 11.6% | 13.2% | 18.2% | 6.1% |
| Diarrhoea | 11.6% | 14% | 11.6% | 7.8% |
| Dyspepsia | 9.1% | 6.6% | 5.8% | 3.5% |
| Nasopharyngitis | 5.8% | 6.6% | 6.6% | 8.7% |
| Decreased appetite | 4.1% | 6.6% | 8.3% | 0.9% |
| Headache | 4.1% | 3.3% | 4.1% | 7.8% |
| Constipation | 5.8% | 5% | 6.6% | 0.9% |
| Vomiting | 3.3% | 2.5% | 5.8% | 1.7% |
| Influenza | 5.8% | 2.5% | 0% | 1.7% |
Secondary outcomes
What else it measured
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=118 | 15 mg Tirzepatiden=116 | Placebon=112 |
|---|---|---|---|
| -7.0(0.52) | -7.8(0.53) | -9.5(0.54) | -0.7(0.57) |
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=118 | 15 mg Tirzepatiden=116 | Placebon=112 |
|---|---|---|---|
| 86.78 | 91.53 | 87.93 | 19.64 |
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=118 | 15 mg Tirzepatiden=116 | Placebon=112 |
|---|---|---|---|
| -43.6(3.40) | -45.9(3.45) | -49.3(3.62) | 12.9(4.00) |
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=118 | 15 mg Tirzepatiden=116 | Placebon=112 |
|---|---|---|---|
| 33.88 | 30.51 | 51.72 | 0.89 |
| Measure | 5 mg Tirzepatiden=115 | 10 mg Tirzepatiden=111 | 15 mg Tirzepatiden=108 | Placebon=101 |
|---|---|---|---|---|
| Morning Premeal - Fasting | -46.9(2.09) | -47.9(2.11) | -45.7(2.23) | -9.2(2.53) |
| Morning 2-hour Postmeal | -69.5(3.41) | -61.4(3.44) | -68.9(3.66) | -11.6(4.12) |
| Midday Premeal | -43.5(2.80) | -42.5(2.82) | -42.7(3.00) | -2.6(3.42) |
| Midday 2-hour Postmeal | -64.2(3.60) | -60.0(3.63) | -63.4(3.84) | -12.7(4.33) |
| Evening Premeal | -44.8(2.80) | -45.1(2.82) | -42.3(3.02) | -5.8(3.38) |
| Evening 2-hour Postmeal | -61.9(3.76) | -62.8(3.81) | -63.5(4.03) | -10.3(4.52) |
| Bedtime | -57.0(3.49) | -59.8(3.52) | -60.8(3.66) | -9.1(4.10) |
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=118 | 15 mg Tirzepatiden=116 | Placebon=112 |
|---|---|---|---|
| 66.94 | 77.97 | 76.72 | 14.29 |
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=119 | 15 mg Tirzepatiden=120 | Placebon=115 |
|---|---|---|---|
| 0.02(0.002) | 0.02(0.002) | 0.02(0.002) | 0.04(0.028) |
| 5 mg Tirzepatiden=121 | 10 mg Tirzepatiden=118 | 15 mg Tirzepatiden=120 |
|---|---|---|
| 86900(25.4) | 171000(26.2) | 252000(23.3) |
The trial
How SURPASS-1 was run
The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.
- 5 mg Tirzepatide: Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
- 10 mg Tirzepatide: Participants received 10mg of tirzepatide as subcutaneous injection once a week.
- 15 mg Tirzepatide: Participants received 15mg of tirzepatide as subcutaneous injection once a week.
- Placebo: Participants received placebo as subcutaneous injection once a week.
Who could join the trial
Inclusion Criteria: * Have been diagnosed with type 2 diabetes mellitus (T2DM). * Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening. * Have HbA1c between ≥7.0% and ≤9.5%. * Be of stable weight (± 5%) for at least 3 months before screening. * Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening. Exclusion Criteria: * Have type 1 diabetes mellitus. * Have had chronic or acute pancreatitis any time prior to study entry. * Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment. * Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. * Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m². * Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months. * Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2. * Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Published papers
Papers from SURPASS-1
- De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12.
- Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5.
- Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1.
- Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
- Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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