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

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Lilly

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Tirzepatide
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05963022
I8F-MC-GPIU (Other Identifier)
18746

Details and patient eligibility

About

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

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

168 participants in 4 patient groups, including a placebo group

Tirzepatide Dose 1
Experimental group
Description:
Participants will receive tirzepatide subcutaneously (SC).
Treatment:
Drug: Tirzepatide
Tirzepatide Dose 2
Experimental group
Description:
Participants will receive tirzepatide SC.
Treatment:
Drug: Tirzepatide
Tirzepatide Dose 3
Experimental group
Description:
Participants will receive tirzepatide SC.
Treatment:
Drug: Tirzepatide
Placebo
Placebo Comparator group
Description:
Participants will receive placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

28

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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