Phase 3
N=257
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
Diabetes Type 2 · Diabetes Mellitus · Glucose Metabolism Disorders · Metabolic Disease · Endocrine System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05691712 ↗Enrolled (actual)
257
Serious AEs
10.9%
Results posted
Aug 2025
Primary outcome: Primary: Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg]) — -26.1; -25.9; -9.96 millimoles per mole (mmol/mol) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tirzepatide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg]) |
-26.1; -25.9; -9.96 | <0.001 sig |
| SECONDARY Mean Change From Baseline in HbA1c (Tirzepatide 5 mg) |
-23.0; -9.96 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Body Weight |
-2.7; -4.8; -4.3; 1.7 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol) |
75.81; 78.95; 78.18; 17.24; 59.68; 77.19 | — |
| SECONDARY Mean Change From Baseline in Fasting Serum Glucose |
-45.5; -52.5; -51.0; -23.7 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg] |
17.54; 25.45; 0.00 | — |
| SECONDARY Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg] |
9.68; 0.00 | — |
| SECONDARY Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles |
-2.62; -2.53; -2.80; -2.22; -4.78; -5.34 | — |
| SECONDARY Percentage of Participants Who Achieved Weight Loss of ≥5% |
25.81; 49.12; 60.00; 1.72 | — |
| SECONDARY Percentage of Participants Who Achieved Weight Loss of ≥10% |
8.06; 21.05; 25.45; 0.00 | — |
| SECONDARY Percentage of Participants Who Achieved Weight Loss of ≥15% |
4.84; 5.26; 9.09; 0.00 | — |
| SECONDARY Percent Change From Baseline in Daily Mean Insulin Glargine Dose |
23.90; 21.95; 18.21; 69.28 | — |
| SECONDARY Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL]) |
59.68; 70.18; 67.27; 5.17 | — |
| SECONDARY Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL]) |
46.77; 70.18; 61.82; 1.72 | — |
| SECONDARY Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia) |
51.61; 57.89; 47.27; 5.17 | — |
| SECONDARY Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia) |
38.71; 57.89; 43.64; 1.72 | — |
Summary
The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes mellitus (T2DM)
- Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol)
- Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days
- Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²)
Exclusion Criteria
- Have type 1 diabetes mellitus (T1DM)
- Have a history of chronic or acute pancreatitis
- Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment
- Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
- Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months
- Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months
- Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory
- Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial only if their ALT level is ≤3.0 times ULN.
Data sourced from ClinicalTrials.gov (NCT05691712). 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.