Study S002017

A Randomized, Double-Blind, Placebo-Controlled Bridging Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Efsubaglutide Alfa in Healthy Adult Participants in Brazil

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT07518121
Acronym: BRIDGE-BR
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: NOT_YET_RECRUITING
Enrollment: 48
Start: 2026-06-01
Primary completion: 2026-08-01
Lead sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Conditions: Diabete Type 2
Interventions: DRUG:Efsubaglutide Alfa Injection; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Maximum Observed Plasma Concentration (Cmax) of YN-011 [Predose through Day 29]
Time to Maximum Observed Plasma Concentration (Tmax) of YN-011 [Predose through Day 29]
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of YN-011 [Predose through Day 29]
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011 [Predose through Day 29]
Terminal Elimination Half-Life (t1/2) of YN-011 [Predose through Day 29]

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