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 — DRUG
    Administered SC
  • Placebo — DRUG
    Administered 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) 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.
  • Experimental: 10 mg 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.
  • Experimental: 15 mg 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 Comparator: Placebo
    Participants 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 ]

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