Primary outcomeLeast squares mean· Baseline, Week 40
Change From Baseline in Hemoglobin A1c (HbA1c)
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -2.19 | 0.121 |
| 10 mg Tirzepatide | -1.75 | 0.131 |
| 15 mg Tirzepatide | -2.03 | 0.124 |
| Placebo | -0.77 | 0.126 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 206 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Double masking
- Countries
1 country
China
- Start
- 21 Aug 2023
- Primary completion
- 9 Oct 2024
- Completion
- 9 Oct 2024
- First posted
- 27 Jul 2023
- Last update posted
- 21 Oct 2025
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
202320242025
- Ph 3
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
NCT0596302221 Aug 2023 to 9 Oct 2024
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.
Interventions
- TirzepatideDrug
- PlaceboDrug
Arms4
Experimental
5 Milligram (mg) Tirzepatide
Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
Experimental
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
Experimental
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
Placebo comparator
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
Secondary outcomes(9)
Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])
Time frame · Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \<7.0% (\<53 mmol/mol) is reported here.
Change From Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 40
Registry description
LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares) as variables.
Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)
Time frame · Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c ≤6.5% (≤48 mmol/Mol) is reported here.
Change From Baseline in Body Weight
Time frame · Baseline, Week 40
Registry description
LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares) as variables.
Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)
Time frame · Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \<5.7% (\<39 mmol/mol) is reported here.
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Time frame · Baseline, Week 40
Registry description
The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.5%, \>8.5%) + Prior Antihyperglycemic Use + Treatment + Time + Treatment\*Time(Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time frame · Week 40
Registry description
Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Percentage of Participants Who Achieved Weight Loss of ≥10%
Time frame · Week 40
Registry description
Percentage of Participants who Achieved Weight Loss ≥10% is reported here.
Percentage of Participants Who Achieved Weight Loss of ≥15%
Time frame · Week 40
Registry description
Percentage of Participants who Achieved Weight Loss ≥15% is reported here.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 40
Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])
| Group | Value (percentage of participants) |
|---|---|
| 5 mg Tirzepatide | 90.38 |
| 10 mg Tirzepatide | 86.36 |
| 15 mg Tirzepatide | 83.33 |
| Placebo | 38.30 |
Secondary outcomeLeast squares mean· Baseline, Week 40
Change From Baseline in Fasting Serum Glucose
| Group | Value (milligram per deciliter (mg/dL)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -55.0 | 3.00 |
| 10 mg Tirzepatide | -54.8 | 3.16 |
| 15 mg Tirzepatide | -55.4 | 3.06 |
| Placebo | -30.2 | 3.07 |
Secondary outcomeNumber· Week 40
Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)
| Group | Value (percentage of participants) |
|---|---|
| 5 mg Tirzepatide | 88.46 |
| 10 mg Tirzepatide | 75.00 |
| 15 mg Tirzepatide | 81.25 |
| Placebo | 23.40 |
Secondary outcomeLeast squares mean· Baseline, Week 40
Change From Baseline in Body Weight
| Group | Value (kilograms (kg)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -6.1 | 0.68 |
| 10 mg Tirzepatide | -5.5 | 0.71 |
| 15 mg Tirzepatide | -8.7 | 0.69 |
| Placebo | -1.3 | 0.70 |
Secondary outcomeNumber· Week 40
Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)
| Group | Value (percentage of participants) |
|---|---|
| 5 mg Tirzepatide | 40.38 |
| 10 mg Tirzepatide | 34.09 |
| 15 mg Tirzepatide | 56.25 |
| Placebo | 0 |
Secondary outcomeLeast squares mean· Baseline, Week 40
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
| Group | Value (milligram per deciliter (mg/dL)) | Spread |
|---|---|---|
| 5 mg Tirzepatide | -78.4 | 3.959 |
| 10 mg Tirzepatide | -78.3 | 4.185 |
| 15 mg Tirzepatide | -80.8 | 4.186 |
| Placebo | -33.9 | 5.223 |
Secondary outcomeNumber· Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5%
| Group | Value (percentage of participants) |
|---|---|
| 5 mg Tirzepatide | 54.90 |
| 10 mg Tirzepatide | 66.67 |
| 15 mg Tirzepatide | 88.37 |
| Placebo | 7.41 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 5 mg TirzepatideParticipants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | 0 / 52 | 5 / 52 | 41 / 52 |
| 10 mg TirzepatideParticipants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | 0 / 51 | 6 / 51 | 44 / 51 |
| 15 mg TirzepatideParticipants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached. | 0 / 52 | 3 / 52 | 45 / 52 |
| PlaceboParticipants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks. | 0 / 51 | 5 / 51 | 36 / 51 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2026
8 results
Tirzepatide monotherapy in Chinese patients with early type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial (SURPASS-CN-MONO).
Yin et al. 2026Med (New York, N.Y.)
PMID 42296968DOI 10.1016/j.medj.2026.101183PUB-42296968
Full text at the publisher8 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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