Efficacy, Safety and Cardiovascular Protection of Mazdutide in Type 1 Diabetes

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 182

Sponsor: Peking University People's Hospital

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with type 1 diabetes (T1D), conducted in two stages. Stage 1 is the efficacy and safety assessment (TIMES-EFFICACY). A total of 182 T1D patients who meet the inclusion criteria will be randomized in a 1:1 ratio to two groups: one receiving mazdutide and the other receiving placebo. The follow-up period is 16 weeks. The primary clinical endpoint is the proportion of patients achieving time in range (TIR) \>70% with time below range (TBR) \

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years at screening. 2. Patients with a clinical diagnosis of T1D for at least 12 months. Patients with T1D must satisfy all three of the following features: 1. Clinical diagnosis of type 1 diabetes by a specialist physician; 2. Any one of the following: age at onset \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07924553). StuddyBuddy aggregates publicly available trial information.