NCT05963022

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

Completed Phase 3 Results posted Last updated 21 October 2025

What this trial tests

Phase 3 trial testing Tirzepatide in Type 2 Diabetes in 206 participants. Completed in 9 October 2024.

Timeline

21 August 2023

Primary endpoint
9 October 2024

9 October 2024

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	206
Start date	21 August 2023
Primary completion	9 October 2024
Estimated completion	9 October 2024
Sites	28 locations across China

Drugs / interventions tested

• Tirzepatide (TIRZEPATIDE) — full drug profile →
• Placebo

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Hemoglobin A1c (HbA1c) Primary · 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.

Group	Value	95% CI
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

Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol]) Secondary · Week 40

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.

Group	Value	95% CI
5 mg Tirzepatide	90.38
10 mg Tirzepatide	86.36
15 mg Tirzepatide	83.33
Placebo	38.30

Change From Baseline in Fasting Serum Glucose Secondary · Baseline, Week 40

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.

Group	Value	95% CI
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

Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol) Secondary · Week 40

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.

Group	Value	95% CI
5 mg Tirzepatide	88.46
10 mg Tirzepatide	75.00
15 mg Tirzepatide	81.25
Placebo	23.40

Change From Baseline in Body Weight Secondary · Baseline, Week 40

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.

Group	Value	95% CI
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

Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol) Secondary · Week 40

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.

Group	Value	95% CI
5 mg Tirzepatide	40.38
10 mg Tirzepatide	34.09
15 mg Tirzepatide	56.25
Placebo	0

Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG) Secondary · Baseline, Week 40

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 f

Group	Value	95% CI
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

Percentage of Participants Who Achieved Weight Loss of ≥5% Secondary · Week 40

Percentage of Participants who Achieved Weight Loss ≥5% is reported here.

Group	Value	95% CI
5 mg Tirzepatide	54.90
10 mg Tirzepatide	66.67
15 mg Tirzepatide	88.37
Placebo	7.41

Percentage of Participants Who Achieved Weight Loss of ≥10% Secondary · Week 40

Percentage of Participants who Achieved Weight Loss ≥10% is reported here.

Group	Value	95% CI
5 mg Tirzepatide	27.45
10 mg Tirzepatide	33.33
15 mg Tirzepatide	58.14
Placebo	0

Percentage of Participants Who Achieved Weight Loss of ≥15% Secondary · Week 40

Percentage of Participants who Achieved Weight Loss ≥15% is reported here.

Group	Value	95% CI
5 mg Tirzepatide	9.80
10 mg Tirzepatide	13.33
15 mg Tirzepatide	37.21
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to week 44. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

5 mg Tirzepatide

Serious: 5/52 (10%)

Deaths: 0/52

10 mg Tirzepatide

Serious: 6/51 (12%)

Deaths: 0/51

15 mg Tirzepatide

Serious: 3/52 (6%)

Deaths: 0/52

Placebo

Serious: 5/51 (10%)

Deaths: 0/51

Serious adverse events (21 terms)

Reaction	System	5 mg Tirzepatide	10 mg Tirzepatide	15 mg Tirzepatide	Placebo
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—
Angina unstable	Cardiac disorders	—	—	—	—
Arteriosclerosis coronary artery	Cardiac disorders	—	—	—	—
Cataract	Eye disorders	—	—	—	—
Optic ischaemic neuropathy	Eye disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Large intestine polyp	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—
Fracture	Injury, poisoning and procedural complications	—	—	—	—
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—
Myasthenia gravis	Nervous system disorders	—	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—
Nephrotic syndrome	Renal and urinary disorders	—	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—	—
Postmenopausal haemorrhage	Reproductive system and breast disorders	—	—	—	—
Nasal cavity mass	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—

Other adverse events (33 terms — click to expand)

Reaction	System	5 mg Tirzepatide	10 mg Tirzepatide	15 mg Tirzepatide	Placebo
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Regurgitation	Gastrointestinal disorders	—	—	—	—
Injection site reaction	General disorders	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Amylase increased	Investigations	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—
Lipase increased	Investigations	—	—	—	—
Dyslipidaemia	Metabolism and nutrition disorders	—	—	—	—
Hyperlipidaemia	Metabolism and nutrition disorders	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—
Atrioventricular block first degree	Cardiac disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Vaginal infection	Infections and infestations	—	—	—	—
Endometrial hyperplasia	Reproductive system and breast disorders	—	—	—	—
Menopausal symptoms	Reproductive system and breast disorders	—	—	—	—

Most-reported serious reactions: Intervertebral disc protrusion, Angina unstable, Arteriosclerosis coronary artery, Cataract, Optic ischaemic neuropathy, Abdominal pain, Large intestine polyp, Nausea.

Data from ClinicalTrials.gov NCT05963022 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The adverse effects associated with tirzepatide use in patients at increased risk of cardiovascular events: a systematic review with meta-analysis and Trial Sequential Analysis.
   Sillassen CDB, Faltermeier P, Bjerg JL, Andersen RK, et al · · 2026 · PMID 41896878 · DOI 10.1186/s12916-026-04824-w