Diabetes Type 2Phase 3SURPASS-CN-INSNCT05691712
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
A Phase 3 study testing Tirzepatide in people with Diabetes Type 2 and Diabetes Mellitus, run by Eli Lilly and Company at 25 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders
- 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
- 257 participants
- Where
- 25 sitesChina
- Study dates
- 5 Feb 2023to 1 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Baotou Central Hospital
Baotou, Inner Mongolia, 014040
Beijing Hospital
Beijing, Beijing Municipality, 100005
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, 101200
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213000
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014
The First Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The Second People's Hospital of Hefei
Hefei, Anhui, 230011
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Jinan Central Hospital
Jinan, Shandong, 250013
The First Affiliated Hospital of Henan University of Science &Technology
LuoyangShi, Henan, 471003
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330009
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
The Affiliated Jiangyin Hospital of Southeast University Medical College
WuxiShi, Jiangsu, 214400
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, 710077
The First People's Hospital of Yueyang
Yueyang, Hunan, 414000
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000
About this study
Official title: A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes
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.
- Conditions
- Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
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 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 injection 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.
Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])
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 mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Measured: Baseline, Week 40
Secondary outcomes (15)
Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using MMRM for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Measured: Baseline, Week 40
Mean Change From Baseline in Body Weight
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Measured: Baseline, Week 40
Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤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 <7.0% (53 millimole/mole [mmol/mol]) and ≤6.5% (48 mmol/mol) is reported here.
Measured: Week 40
Mean Change From Baseline in Fasting Serum Glucose
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Measured: Baseline, Week 40
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c <5.7% (39 mmol/Mol) is reported here.
Measured: Week 40
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c <5.7% (39 mmol/Mol) is reported here.
Measured: Week 40
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
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 MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. 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
Percent Change From Baseline in Daily Mean Insulin Glargine Dose
LS Mean was calculated using MMRM for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Measured: Baseline, Week 40
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])
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]) is reported here
Measured: Week 40
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])
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]) is reported here.
Measured: Week 40
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)
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) is reported here.
Measured: Week 40
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)
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) 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.
- First posted20 Jan 2023
- Study start5 Feb 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 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 Diabetes Type 2Studies 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
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691712
- Sponsor's protocol ID
- 18552
- Other IDs
- I8F-MC-GPIM
- Acronym
- SURPASS-CN-INS
- Status last verified
- Jul 2025
- First submitted
- 11 Jan 2023
- Last updated
- 8 Aug 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
Guo L, Dong X, Ma J, Liu M, Lu Y, Wang H, Li Q, Li L, Deng Y, Xu J. Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Dec;13(12):1015-1029. doi: 10.1016/S2213-8587(25)00248-7. Epub 2025 Oct 27.
PubMed 41167231
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05691712
- Acronym / sponsor ID
- SURPASS-CN-INS / 18552
- Conditions
- Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Posted 8 Aug 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 compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control 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 injection 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
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
Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])
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 mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
15 secondary outcomes
Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)
Time frame: Baseline, Week 40
Mean Change From Baseline in Body Weight
Time frame: Baseline, Week 40
Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)
Time frame: Week 40
Mean Change From Baseline in Fasting Serum Glucose
Time frame: Baseline, Week 40
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]
Time frame: Week 40
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]
Time frame: Week 40
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
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
Percent Change From Baseline in Daily Mean Insulin Glargine Dose
Time frame: Baseline, Week 40
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])
Time frame: Week 40
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])
Time frame: Week 40
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)
Time frame: Week 40
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)
Time frame: Week 40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41167231Guo L, Dong X, Ma J, Liu M, Lu Y, Wang H, Li Q, Li L, Deng Y, Xu J. Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Dec;13(12):1015-1029. doi: 10.1016/S2213-8587(25)00248-7. Epub 2025 Oct 27.
- 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
25 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 Diabetes Type 2 and Diabetes Mellitus, run by Eli Lilly and Company at 25 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 9 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 8 Aug 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?
Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg]) (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 NCT05691712, 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 8 Aug 2025.