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

A Phase 3 study testing Tirzepatide in people with Type 2 Diabetes, run by Eli Lilly and Company at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Tirzepatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 206 participants
Where: 28 sitesChina
Study dates: 21 Aug 2023to 9 Oct 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

China28 sites

Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
The First People's Hospital of Changde City
Changde, Hunan, 415003
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Dalian University - The Affiliated Zhongshan Hospital
Dalian, Liaoning, 116001
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, 528399
Hainan General Hospital
Haikou, Hainan, 570311
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Jinan Central Hospital
Jinan, Shandong, 250013
Panjin Liaoyou Baoshihua Hospital
Liaoyou, Liaoning, 124009
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Nanjing First Hospital
Nanjing, Jiangsu, 210012
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, 201200
Jiading District Central Hospital
Shanghai, Shanghai Municipality, 201800
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, 710077
Yichang Central People's Hospital
Yichang, Hubei, 443003
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000
Zunyi First People's Hospital
Zunyi, Guizhou, 563002

Other trials in China

About this study

Official title: 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

The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.

Conditions: Type 2 Diabetes
Being tested: Tirzepatide, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT05963022
Study group	Role	What they receive
5 Milligram (mg) Tirzepatide	Experimental	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. Receives: Drug: Tirzepatide
10 mg Tirzepatide	Experimental	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. Receives: Drug: Tirzepatide
15 mg Tirzepatide	Experimental	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. Receives: Drug: Tirzepatide
Placebo	Placebo comparator	Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin A1c (HbA1c)
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.
Measured: Baseline, Week 40

Secondary outcomes (9)

Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])
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.
Measured: Week 40
Change From Baseline in Fasting Serum Glucose
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.
Measured: Baseline, Week 40
Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)
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.
Measured: Week 40
Change From Baseline in Body Weight
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.
Measured: Baseline, Week 40
Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)
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.
Measured: Week 40
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
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.
Measured: Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5%
Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Measured: Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10%
Percentage of Participants who Achieved Weight Loss ≥10% is reported here.
Measured: Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15%
Percentage of Participants who Achieved Weight Loss ≥15% is reported here.
Measured: Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 20239 Oct 2024

First posted27 Jul 2023
Study start21 Aug 2023
Primary completion9 Oct 2024
Study completion9 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05963022
Sponsor's protocol ID: 18746
Other IDs: I8F-MC-GPIU
Status last verified: Oct 2025
First submitted: 19 Jul 2023
Last updated: 21 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Yin Y, Ma J, Liu D, Duan W, Cheng Z, Jiang H, Zhang Y, Wu G, Zhuang H, Gu W, Mu Y. Tirzepatide monotherapy in Chinese patients with early type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial (SURPASS-CN-MONO). Med. 2026 Jul 10;7(7):101183. doi: 10.1016/j.medj.2026.101183. Epub 2026 Jun 15.
PubMed 42296968

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05963022
Acronym / sponsor ID: 18746
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 21 Aug 2023 (actual)
Primary completion: 9 Oct 2024 (actual)
Study completion: 9 Oct 2024 (actual)
First posted: 27 Jul 2023 (actual)
Results: Posted 21 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
5 Milligram (mg) Tirzepatide	Experimental	Drug: TirzepatideParticipants 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.
10 mg Tirzepatide	Experimental	Drug: 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.
15 mg Tirzepatide	Experimental	Drug: 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.
Placebo	Placebo comparator	Drug: PlaceboParticipants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TirzepatideAlso: LY3298176Administered SC	Drug	10 mg Tirzepatide, 15 mg Tirzepatide, 5 Milligram (mg) Tirzepatide
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 40
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.

9 secondary outcomes

Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])
Time frame: Week 40
Change From Baseline in Fasting Serum Glucose
Time frame: Baseline, Week 40
Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)
Time frame: Week 40
Change From Baseline in Body Weight
Time frame: Baseline, Week 40
Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)
Time frame: Week 40
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Time frame: Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time frame: Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10%
Time frame: Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15%
Time frame: Week 40

Results and safety

Results posted to the registry on 21 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5 Milligram (mg) Tirzepatide	52	52
10 mg Tirzepatide	51	46
15 mg Tirzepatide	52	48
Placebo	51	47

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame: Baseline, Week 40. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	5 mg Tirzepatide n = 52	10 mg Tirzepatide n = 44	15 mg Tirzepatide n = 48	Placebo n = 47
Value	-2.19 (0.121)	-1.75 (0.131)	-2.03 (0.124)	-0.77 (0.126)

5 mg Tirzepatide vs Placebo: LS Mean Difference: -1.42 (95% CI -1.76 to -1.07), p <0.001, ANCOVA
10 mg Tirzepatide vs Placebo: LS Mean Difference: -0.98 (95% CI -1.34 to -0.63), p <0.001, ANCOVA
15 mg Tirzepatide vs Placebo: LS Mean Difference: -1.26 (95% CI -1.61 to -0.92), p <0.001, ANCOVA

Population analysed: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to week 44. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5 mg Tirzepatide	5 of 52 (9.6%)	41 of 52 (78.8%)	0 of 52
10 mg Tirzepatide	6 of 51 (11.8%)	44 of 51 (86.3%)	0 of 51
15 mg Tirzepatide	3 of 52 (5.8%)	45 of 52 (86.5%)	0 of 52
Placebo	5 of 51 (9.8%)	36 of 51 (70.6%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42296968Yin Y, Ma J, Liu D, Duan W, Cheng Z, Jiang H, Zhang Y, Wu G, Zhuang H, Gu W, Mu Y. Tirzepatide monotherapy in Chinese patients with early type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial (SURPASS-CN-MONO). Med. 2026 Jul 10;7(7):101183. doi: 10.1016/j.medj.2026.101183. Epub 2026 Jun 15.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide in people with Type 2 Diabetes, run by Eli Lilly and Company at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05963022, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.