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CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Tirzepatide Monotherapy Compared With Placebo in Chinese Participants With Type 2 Diabetes

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

28

Recruiting sites

Enrollment

206

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI ≥23HbA1c ≥7%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05963022
Org study ID18746
Secondary IDI8F-MC-GPIUEli Lilly and Company

Timeline

Milestones

Study first posted2023-07-27actual
Study start2023-08-21actual
Primary completion2024-10-09actual
Study completion2024-10-09actual
Last update posted2025-10-21actual
Results first posted2025-10-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
12
Weight & body composition
8

Weight & body composition

8 endpoints
Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms (kg)95% CI
5 mg Tirzepatide-6.1
10 mg Tirzepatide-5.5
15 mg Tirzepatide-8.7
Placebo-1.3
LS Mean Difference-4.895% CI-6.7-2.9p<0.001ANCOVA
LS Mean Difference-4.295% CI-6.2-2.3p<0.001ANCOVA
LS Mean Difference-7.395% CI-9.3-5.4p<0.001ANCOVA
Secondary/registry result

Percentage of Participants Who Achieved Weight Loss of ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
5 mg Tirzepatide54.90
10 mg Tirzepatide66.67
15 mg Tirzepatide88.37
Placebo7.41
Odds Ratio (OR)18.1995% CI5.2762.73p<0.001Regression, Logistic
Odds Ratio (OR)30.9695% CI8.87108.05p<0.001Regression, Logistic
Odds Ratio (OR)73.4295% CI19.36278.40p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieved Weight Loss of ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
5 mg Tirzepatide27.45
10 mg Tirzepatide33.33
15 mg Tirzepatide58.14
Placebo0
Odds Ratio (OR)39.0495% CI2.29664.36p0.011Regression, Logistic
Odds Ratio (OR)56.3495% CI3.34949.59p0.005Regression, Logistic
Odds Ratio (OR)127.5295% CI7.582145.42p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieved Weight Loss of ≥15%

Time frame:Week 40

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
5 mg Tirzepatide9.80
10 mg Tirzepatide13.33
15 mg Tirzepatide37.21
Placebo0
Odds Ratio (OR)13.8695% CI0.75254.78p0.077Regression, Logistic
Odds Ratio (OR)15.6595% CI0.87281.74p0.062Regression, Logistic
Odds Ratio (OR)66.6995% CI3.901140.13p0.004Regression, Logistic
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥15%

Time frame:Week 40

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

12 endpoints
Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
5 mg Tirzepatide-2.19
10 mg Tirzepatide-1.75
15 mg Tirzepatide-2.03
Placebo-0.77
LS Mean Difference-1.4295% CI-1.76-1.07p<0.001ANCOVA
LS Mean Difference-0.9895% CI-1.34-0.63p<0.001ANCOVA
LS Mean Difference-1.2695% CI-1.61-0.92p<0.001ANCOVA
Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
5 mg Tirzepatide90.38
10 mg Tirzepatide86.36
15 mg Tirzepatide83.33
Placebo38.30
Odds Ratio (OR)17.0495% CI5.6251.73p<0.001Regression, Logistic
Odds Ratio (OR)7.5195% CI2.7720.37p<0.001Regression, Logistic
Odds Ratio (OR)7.2495% CI2.7419.14p<0.001Regression, Logistic
Secondary/registry result

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), milligram per deciliter (mg/dL)95% CI
5 mg Tirzepatide-55.0
10 mg Tirzepatide-54.8
15 mg Tirzepatide-55.4
Placebo-30.2
LS Mean Difference-24.895% CI-33.3-16.3p<0.001ANCOVA
LS Mean Difference-24.695% CI-33.2-15.9p<0.001ANCOVA
LS Mean Difference-25.295% CI-33.7-16.7p<0.001ANCOVA
Secondary/registry result

Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
5 mg Tirzepatide88.46
10 mg Tirzepatide75.00
15 mg Tirzepatide81.25
Placebo23.40
Odds Ratio (OR)25.6195% CI8.7075.36p<0.001Regression, Logistic
Odds Ratio (OR)7.2595% CI2.8818.25p<0.001Regression, Logistic
Odds Ratio (OR)10.9595% CI4.2328.34p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
5 mg Tirzepatide40.38
10 mg Tirzepatide34.09
15 mg Tirzepatide56.25
Placebo0
Odds Ratio (OR)76.6295% CI4.401333.29p0.003Regression, Logistic
Odds Ratio (OR)49.3695% CI2.80868.67p<0.001Regression, Logistic
Odds Ratio (OR)118.2295% CI6.802055.04p<0.001Regression, Logistic
Secondary/registry result

Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

Time frame:Baseline, Week 40

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), milligram per deciliter (mg/dL)95% CI
5 mg Tirzepatide-78.4
10 mg Tirzepatide-78.3
15 mg Tirzepatide-80.8
Placebo-33.9
LS Mean Difference-44.595% CI-57.5-31.5p<0.001Mixed Models Analysis
LS Mean Difference-44.395% CI-57.6-31.1p<0.001Mixed Models Analysis
LS Mean Difference-46.995% CI-60.1-33.7p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

Time frame:Baseline, Week 40

Postprandial glucose

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.