Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
NCT Number: NCT07796477
This study is a multicenter, randomized, double-blind, placebo and active-controlled, dose-finding phase 2 study aimed to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SYH2069 Injection in participants with Type 2 Diabetes Mellitus (T2DM) inadequate glycemic control with diet and exercise alone or metformin monotherapy.
The study consists of four periods: a 2-week screening period, a 3-week run-in period, a 28-week treatment period and a 3-week safety follow-up period.
A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or >8.5%) and prior metformin use (yes or no) , then randomized 4:1:4:1:4:1:4:1:4 to SYH2069 group 1, SYH2069 group 1 placebo, SYH2069 group 2, SYH2069 group 2 placebo, SYH2069 group 3, SYH2069 group 3 placebo, SYH2069 group 4, SYH2069 group 4 placebo and Tirzepatide injection 15mg, with 40 participants in each SYH2069 or Tirzepatide group and 10 participants in each SYH2069 placebo group. All treatment groups will implement dose titration to achieve the target dose.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Nanjing, Jiangsu, 210029, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
administered subcutaneously (SC), Once-Weekly (QW), 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Time frame: Baseline,Week 28
Contact information is provided by the study sponsor or research team.
CSPC Ouyi Pharmaceutical Co., Ltd.
Industry
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of SYH2069 Injection in Participants With Type 2 Diabetes Mellitus With Inadquate Glycemic Control After Diet and Exercise Alone or Metformin Monotherapy
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.
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