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

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Tirzepatide
Drug: Placebo

Registration Number: NCT05963022

Lead Sponsor: Eli Lilly and Company

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 206

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 Milligram (mg) Tirzepatide	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	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	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	Placebo	Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (28): Chinese PLA General Hospital
🇨🇳
Beijing, Beijing Municipality, China
Shunde Hospital of Southern Medical Univesity
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Foshan, Guangdong, China
Huizhou Municipal Central Hospital
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Huizhou, Guangdong, China
Zunyi First People's Hospital
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Zunyi, Guizhou, China
Hainan General Hospital
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Haikou, Hainan, China
The Fourth Affiliated Hospital of Harbin Medical University
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Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
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Luoyang Shi, Henan, China
The First Affiliated Hospital of Nanyang Medical College
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Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, China
Yichang Central People's Hospital
🇨🇳
Yichang, Hubei, China
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Chinese PLA General Hospital
🇨🇳Beijing, Beijing Municipality, China