Phase 3
N=206
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05963022 ↗Enrolled (actual)
206
Serious AEs
9.2%
Results posted
Oct 2025
Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) — -2.19; -1.75; -2.03; -0.77 percentage of HbA1c — 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
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-2.19; -1.75; -2.03; -0.77 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol]) |
90.38; 86.36; 83.33; 38.30 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
-55.0; -54.8; -55.4; -30.2 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol) |
88.46; 75.00; 81.25; 23.40 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-6.1; -5.5; -8.7; -1.3 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol) |
40.38; 34.09; 56.25; 0 | 0.003 sig |
| SECONDARY Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG) |
-78.4; -78.3; -80.8; -33.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Weight Loss of ≥5% |
54.90; 66.67; 88.37; 7.41 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Weight Loss of ≥10% |
27.45; 33.33; 58.14; 0 | 0.011 sig |
| SECONDARY Percentage of Participants Who Achieved Weight Loss of ≥15% |
9.80; 13.33; 37.21; 0 | 0.077 |
Summary
The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.
Eligibility Criteria
Inclusion Criteria
- Have Type 2 Diabetes
- Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment
- Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
- Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)
Exclusion Criteria
- Have Type 1 Diabetes
- Have a history of chronic or acute pancreatitis any time prior to study entry
- Are currently receiving treatment for diabetic retinopathy and/or macular edema
- Have a history of ketoacidosis or hyperosmolar state/coma
- Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)
- Have acute or chronic hepatitis including a history of autoimmune hepatitis
- Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
Data sourced from ClinicalTrials.gov (NCT05963022). 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.