Phase 2
Completed N=318
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03131687 ↗Enrolled (actual)
318
Serious AEs
4.1%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response — -0.06; -1.06; -1.73; -1.89 Percentage of HbA1c
Summary
The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response |
-0.06; -1.06; -1.73; -1.89; -1.94; -1.21 | — |
| SECONDARY Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response |
-0.05; -0.94; -1.54; -1.68; -1.72; -1.08 | — |
| SECONDARY Change From Baseline to Week 26 in HbA1c |
0.1; -0.7; -1.6; -2.0; -2.4; -1.1 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 in HbA1c |
-0.1; -0.9; -1.7; -2.0; -2.1; -1.2 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-0.4; -0.9; -4.8; -8.7; -11.3; -2.7 | 0.655 |
| SECONDARY Percentage of Participants With 5% or Greater Body Weight Loss From Baseline |
0; 13.5; 47.3; 70.6; 62.3; 22.2 | 0.053 |
| SECONDARY Percentage of Participants With 10% or Greater Body Weight Loss From Baseline |
0; 5.8; 16.4; 39.2; 37.7; 9.3 | 0.193 |
| SECONDARY Percentage of Participants Reaching the HbA1c Target of ≤6.5% |
2.0; 15.4; 63.6; 82.0; 58.5; 38.9 | 0.030 sig |
| SECONDARY Percentage of Participants Reaching the HbA1c Target of <7.0% |
11.8; 32.7; 69.1; 90.0; 77.4; 51.9 | 0.008 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
15.5; -6.8; -40.7; -60.7; -57.5; -21.2 | 0.010 sig |
| SECONDARY Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) |
0.0; -0.0; 0.0; 0.0; 0.1; 0.0 | 0.396 |
| SECONDARY Change From Baseline in Total Cholesterol |
0.3; 0.2; -0.1; -0.3; -0.3; -0.2 | 0.565 |
| SECONDARY Change From Baseline in Triglycerides |
0.3; -0.0; -0.5; -0.7; -0.8; -0.3 | 0.164 |
| SECONDARY Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) |
0.2; 0.2; 0.0; -0.0; -0.1; -0.1 | 0.919 |
| SECONDARY Change From Baseline in Waist Circumference |
-1.3; -2.1; -5.1; -7.4; -10.2; -2.5 | 0.539 |
| SECONDARY Number of Participants With Anti-Drug Antibodies |
0; 16; 19; 24; 26; 0 | — |
| SECONDARY Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide |
78.6; 394; 787; 1180 | — |
Eligibility Criteria
Inclusion Criteria
- Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification.
- Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
- If on metformin, have been treated with stable doses of metformin for at least 3 months.
- Have a body mass index (BMI) ≥23 and 2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
- Have had chronic or acute pancreatitis any time prior to study entry.
- Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
- Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
- Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.
Data sourced from ClinicalTrials.gov (NCT03131687). 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.