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

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: 206 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

---

206 participants in 4 patient groups, including a placebo group

5 Milligram (mg) Tirzepatide

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo