A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT05963022
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tirzepatide — DRUGAdministered SC
- Placebo — DRUGAdministered SC
Study Details
The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.
Key Dates
- Start date
- Aug 21, 2023
- Status verified
- Oct 2025
- Primary completion
- Oct 9, 2024
- Completion
- Oct 9, 2024
Study Design
- Enrollment
- 206 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 5 Milligram (mg) TirzepatideParticipants 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.
- Experimental: 10 mg TirzepatideParticipants 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.
- Experimental: 15 mg TirzepatideParticipants 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 Comparator: PlaceboParticipants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
Primary Outcome Measure
Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]
Related coverage on Hipa.ai
- Tirzepatide Monotherapy Shows Significant HbA1c Reduction in Type 2 DiabetesTirzepatide · Oct 21, 2025 · ClinicalTrials.gov
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