Phase 3
Completed N=478
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Source: ClinicalTrials.gov NCT03954834 ↗Enrolled (actual)
478
Serious AEs
2.3%
Results posted
Oct 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -1.87; -1.89; -2.07; 0.04 Percentage of HbA1c — p=<0.001
◆ Published Evidence
Highly cited
982citations · ~196 / year
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.
Summary
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.
Linked Publications (5)
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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.
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Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis.
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Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme.
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Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics.
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Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-1.87; -1.89; -2.07; 0.04 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-7.0; -7.8; -9.5; -0.7 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c Target Value of <7% |
86.78; 91.53; 87.93; 19.64 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-43.6; -45.9; -49.3; 12.9 | 0.776 |
| SECONDARY Percentage of Participants With HbA1c Target Value of <5.7% |
33.88; 30.51; 51.72; 0.89 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-46.9; -47.9; -45.7; -9.2; -69.5; -61.4 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Weight Loss ≥5% |
66.94; 77.97; 76.72; 14.29 | <0.001 sig |
| SECONDARY Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia |
0.02; 0.02; 0.02; 0.04 | — |
| SECONDARY Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide |
86900; 171000; 252000 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03954834) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.