Primary outcome
What SURPASS-5 measured first
| 10 mg Tirzepatiden=113 | 15 mg Tirzepatiden=117 | Placebon=118 |
|---|---|---|
| -2.59(0.081) | -2.59(0.083) | -0.93(0.079) |
Phase 3 · Tirzepatide
SURPASS-5 trial results
Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) (Percentage of HbA1c), Baseline, Week 40. 10 mg Tirzepatide: -2.59; 15 mg Tirzepatide: -2.59; Placebo: -0.93.
- Participants
- 475
- Status
- completed
- Completed
- 2021-01-13
- Sponsor
- Eli Lilly and Company
As posted on ClinicalTrials.gov (NCT04039503), updated at source Jan 12, 2022. 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-5
Percent of participants affected, Baseline, 17 Months. The most common events the registry lists.
| Event | 5 mg Tirzepatide | 10 mg Tirzepatide | 15 mg Tirzepatide | Placebo |
|---|---|---|---|---|
| Any serious event | 7.8% | 10.9% | 7.5% | 8.3% |
| Diarrhoea | 12.1% | 12.6% | 20.8% | 10% |
| Nasopharyngitis | 15.5% | 6.7% | 12.5% | 19.2% |
| Nausea | 12.9% | 17.6% | 18.3% | 2.5% |
| Decreased appetite | 6.9% | 12.6% | 14.2% | 1.7% |
| Hyperglycaemia | 1.7% | 0% | 0.8% | 13.3% |
| Vomiting | 6.9% | 7.6% | 12.5% | 2.5% |
| Dyspepsia | 6.9% | 8.4% | 5% | 1.7% |
| Lipase increased | 3.4% | 1.7% | 8.3% | 1.7% |
| Constipation | 6% | 6.7% | 6.7% | 1.7% |
| Eructation | 5.2% | 3.4% | 5.8% | 0.8% |
| Flatulence | 2.6% | 5% | 5.8% | 0% |
| Back pain | 5.2% | 5% | 3.3% | 5.8% |
| Hypertension | 2.6% | 2.5% | 0.8% | 5.8% |
| Arthralgia | 5.2% | 3.4% | 2.5% | 1.7% |
Secondary outcomes
What else it measured
| 5 mg Tirzepatiden=115 | Placebon=118 |
|---|---|
| -2.23(0.081) | -0.93(0.079) |
| 5 mg Tirzepatiden=115 | 10 mg Tirzepatiden=113 | 15 mg Tirzepatiden=117 | Placebon=118 |
|---|---|---|---|
| -6.2(0.58) | -8.2(0.58) | -10.9(0.59) | 1.7(0.57) |
| 5 mg Tirzepatiden=115 | 10 mg Tirzepatiden=113 | 15 mg Tirzepatiden=117 | Placebon=118 |
|---|---|---|---|
| 93.04 | 97.35 | 94.02 | 33.90 |
| 5 mg Tirzepatiden=115 | 10 mg Tirzepatiden=116 | 15 mg Tirzepatiden=118 | Placebon=118 |
|---|---|---|---|
| -61.4(2.55) | -67.9(2.55) | -67.7(2.64) | -38.9(2.49) |
| 5 mg Tirzepatiden=100 | 10 mg Tirzepatiden=99 | 15 mg Tirzepatiden=94 | Placebon=97 |
|---|---|---|---|
| -67.1(2.05) | -71.7(2.04) | -73.7(2.10) | -39.4(2.07) |
| 5 mg Tirzepatiden=115 | 10 mg Tirzepatiden=113 | 15 mg Tirzepatiden=117 | Placebon=118 |
|---|---|---|---|
| 53.91 | 64.60 | 84.62 | 5.93 |
| 5 mg Tirzepatiden=105 | 10 mg Tirzepatiden=103 | 15 mg Tirzepatiden=96 | Placebon=111 |
|---|---|---|---|
| 13.0(7.34) | 8.1(7.03) | -11.4(5.85) | 75.0(11.11) |
| 5 mg Tirzepatiden=116 | 10 mg Tirzepatiden=119 | 15 mg Tirzepatiden=120 | Placebon=120 |
|---|---|---|---|
| 0.49(0.141) | 0.66(0.169) | 0.38(0.099) | 0.51(0.149) |
| 5 mg Tirzepatiden=115 | 10 mg Tirzepatiden=116 | 15 mg Tirzepatiden=118 |
|---|---|---|
| 79700(24.5) | 164000(26.7) | 246000(26.4) |
| 5 mg Tirzepatiden=115 | 10 mg Tirzepatiden=113 | 15 mg Tirzepatiden=117 | Placebon=118 |
|---|---|---|---|
| 26.09 | 47.79 | 62.39 | 2.54 |
The trial
How SURPASS-5 was run
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.
- 5 mg Tirzepatide: 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
- 10 mg Tirzepatide: 10 mg tirzepatide administered SC once a week.
- 15 mg Tirzepatide: 15 mg tirzepatide administered SC once a week.
- Placebo: Placebo administered SC once a week.
Who could join the trial
Inclusion Criteria: * Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit. * Have HbA1c between ≥7.0% and ≤10.5%. * Have a stable weight (± 5%) for at least 3 months before screening. * Have a body mass index (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 \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\] * 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-5
- Bajaj HS, Billings LK, Sharma P, Levine JA, Rodriguez A, Patel H. Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin: Pooled Subgroup Analysis of SURPASS-5 and -6. Diabetes Ther. 2026 May;17(5):787-797. doi: 10.1007/s13300-026-01859-3. Epub 2026 Apr 10.
- 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.
- Dahl D, Onishi Y, Norwood P, Huh R, Bray R, Patel H, Rodriguez A. Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):534-545. doi: 10.1001/jama.2022.0078.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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