Phase 3 · Tirzepatide

NCT05963022 trial results

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

Change From Baseline in Hemoglobin A1c (HbA1c) (percentage of HbA1c), Baseline, Week 40. 5 mg Tirzepatide: -2.19; 10 mg Tirzepatide: -1.75; 15 mg Tirzepatide: -2.03; Placebo: -0.77.

Participants: 206
Status: completed
Completed: 2024-10-09
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05963022), updated at source Oct 21, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT05963022 measured first

Change From Baseline in Hemoglobin A1c (HbA1c)percentage of HbA1c · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=52	10 mg Tirzepatiden=44	15 mg Tirzepatiden=48	Placebon=47
-2.19(0.121)	-1.75(0.131)	-2.03(0.124)	-0.77(0.126)

Side effects by arm

Side effects in NCT05963022

Percent of participants affected, Baseline up to week 44. The most common events the registry lists.

Event	5 mg Tirzepatide	10 mg Tirzepatide	15 mg Tirzepatide	Placebo
Any serious event	9.6%	11.8%	5.8%	9.8%
Hyperglycaemia	1.9%	0%	3.8%	33.3%
Diarrhoea	23.1%	23.5%	28.8%	0%
Decreased appetite	28.8%	25.5%	26.9%	0%
Nausea	9.6%	21.6%	26.9%	2%
Upper respiratory tract infection	21.2%	17.6%	17.3%	19.6%
Vomiting	5.8%	7.8%	19.2%	0%
Abdominal distension	15.4%	11.8%	11.5%	2%
Hypertension	5.8%	7.8%	0%	9.8%
Regurgitation	5.8%	5.9%	9.6%	0%
Injection site reaction	3.8%	3.9%	9.6%	0%
Respiratory tract infection	9.6%	2%	1.9%	3.9%
Amylase increased	3.8%	3.9%	9.6%	0%
Hyperuricaemia	9.6%	5.9%	7.7%	5.9%
Vaginal infection	0%	5%	0%	9.1%
Constipation	7.7%	7.8%	5.8%	0%
Eructation	1.9%	7.8%	5.8%	0%
Dyslipidaemia	3.8%	3.9%	3.8%	7.8%
Hyperlipidaemia	3.8%	7.8%	0%	3.9%
Hypoaesthesia	0%	7.8%	0%	0%
Lipase increased	7.7%	3.9%	7.7%	0%
Atrioventricular block first degree	0%	5.9%	0%	0%
Tachycardia	1.9%	5.9%	0%	0%
Conjunctivitis	0%	5.9%	0%	0%
Influenza	3.8%	5.9%	1.9%	3.9%
Hypokalaemia	0%	5.9%	1.9%	2%

Secondary outcomes

What else it measured

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

5 mg Tirzepatiden=52	10 mg Tirzepatiden=44	15 mg Tirzepatiden=48	Placebon=47
90.38	86.36	83.33	38.30

Change From Baseline in Fasting Serum Glucosemilligram per deciliter (mg/dL) · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=51	10 mg Tirzepatiden=46	15 mg Tirzepatiden=48	Placebon=49
-55.0(3.00)	-54.8(3.16)	-55.4(3.06)	-30.2(3.07)

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

5 mg Tirzepatiden=52	10 mg Tirzepatiden=44	15 mg Tirzepatiden=48	Placebon=47
88.46	75.00	81.25	23.40

Change From Baseline in Body Weightkilograms (kg) · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=52	10 mg Tirzepatiden=46	15 mg Tirzepatiden=48	Placebon=49
-6.1(0.68)	-5.5(0.71)	-8.7(0.69)	-1.3(0.70)

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

5 mg Tirzepatiden=52	10 mg Tirzepatiden=44	15 mg Tirzepatiden=48	Placebon=47
40.38	34.09	56.25	0

Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)milligram per deciliter (mg/dL) · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=51	10 mg Tirzepatiden=45	15 mg Tirzepatiden=43	Placebon=27
-78.4(3.959)	-78.3(4.185)	-80.8(4.186)	-33.9(5.223)

Percentage of Participants Who Achieved Weight Loss of ≥5%percentage of participants · Week 40 · number

5 mg Tirzepatiden=51	10 mg Tirzepatiden=45	15 mg Tirzepatiden=43	Placebon=27
54.90	66.67	88.37	7.41

Percentage of Participants Who Achieved Weight Loss of ≥10%percentage of participants · Week 40 · number

5 mg Tirzepatiden=51	10 mg Tirzepatiden=45	15 mg Tirzepatiden=43	Placebon=27
27.45	33.33	58.14	0

Percentage of Participants Who Achieved Weight Loss of ≥15%percentage of participants · Week 40 · number

5 mg Tirzepatiden=51	10 mg Tirzepatiden=45	15 mg Tirzepatiden=43	Placebon=27
9.80	13.33	37.21	0

The trial

How NCT05963022 was run

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

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.
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.
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: Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Who could join the trial

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.

Published papers

Papers from NCT05963022

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.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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