Study S000981

BALANCE-DM2: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) in Latin American Adults With Type 2 Diabetes Mellitus

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: NCT07628985
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: NOT_YET_RECRUITING
Enrollment: 374
Start: 2026-09
Primary completion: 2027-10
Lead sponsor: Carnot Laboratories
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: BIOLOGICAL:Bofanglutide; BIOLOGICAL:Semaglutide
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30 [Baseline to Week 30]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0021091	The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Liu Y, Diabetes, obesity & metabolism	2025	Randomized trial	PMID 40028667 DOI	registry reference BACKGROUND:40028667
R0016977	GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models. Zhang M, European journal of pharmacology	2022	Preclinical	PMID 35718129 DOI	registry reference BACKGROUND:35718129