Skip to main content
OpenTrials
Completed

NCT Number: NCT05963022

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chinese PLA General Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])

    Time frame: 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.

  2. Change From Baseline in Fasting Serum Glucose

    Time frame: 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.

  3. Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)

    Time frame: 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.

  4. Change From Baseline in Body Weight

    Time frame: 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.

  5. Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)

    Time frame: 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.

  6. Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

    Time frame: 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.

  7. Percentage of Participants Who Achieved Weight Loss of ≥5%

    Time frame: Week 40

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

  8. Percentage of Participants Who Achieved Weight Loss of ≥10%

    Time frame: Week 40

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

  9. Percentage of Participants Who Achieved Weight Loss of ≥15%

    Time frame: Week 40

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.