LivingGLP1
Study S001387

Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide: A Multicenter, Prospective, Randomized Controlled Trial (IIT)

ClinicalTrials.gov record

Registration

Registration
NCT07713992
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Status
NOT_YET_RECRUITING
Enrollment
72
Start
2026-09-15
Primary completion
2027-12-31
Lead sponsor
Tianjin Medical University
Conditions
Type 2 Diabetes Mellitus (T2DM); Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
Interventions
DRUG:Mazdutide(Dual GLP-1R/GCGR Agonist); DRUG:Semaglutide (1 Mg Dose)
Results posted
FALSE
Individual participant data sharing
NO

Registered primary outcomes

  • Absolute change in liver fat content measured by MRI-PDFF [Baseline, Week 16, Week 32]
  • Absolute change in liver fat content measured by liver transient elastography [Baseline, Week 16, Week 32]

Linked records (8)

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.
RecordTitleYearDesignIdentifiersLink basis
R0012473Changes in weight and glycemic control following obesity treatment with semaglutide or tirzepatide by discontinuation status.
Gasoyan H, Obesity (Silver Spring, Md.)
2025Nonrandomized studyPMID 40491239DOIregistry reference BACKGROUND:40491239
R0021294Characterizing body composition modifying effects of a glucagon-like peptide 1 receptor-based agonist: A meta-analysis.
Jiao R, Diabetes, obesity & metabolism
2025Systematic reviewPMID 39431379DOIregistry reference BACKGROUND:39431379
R0016031The therapeutic potential of GLP-1 receptor biased agonism.
Jones B, British journal of pharmacology
2022PreclinicalPMID 33880754DOIregistry reference BACKGROUND:33880754
R0020435The incretin/glucagon system as a target for pharmacotherapy of obesity.
Del Prato S, Obesity reviews : an official journal of the International Association for the Study of Obesity
2022Narrative reviewPMID 34713962DOIregistry reference BACKGROUND:34713962
R0023084The evolving story of incretins (GIP and GLP-1) in metabolic and cardiovascular disease: A pathophysiological update.
Nauck MA, Diabetes, obesity & metabolism
2021Narrative reviewPMID 34310013DOIregistry reference BACKGROUND:34310013
R0029762Glucagon Control on Food Intake and Energy Balance.
Al-Massadi O, International journal of molecular sciences
2019Narrative reviewPMID 31405212DOIregistry reference BACKGROUND:31405212
R0028716GLP-1/glucagon receptor co-agonism for treatment of obesity.
Sánchez-Garrido MA, Diabetologia
2017Narrative reviewPMID 28733905DOIregistry reference BACKGROUND:28733905
R0024592Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults.
van Can J, International journal of obesity (2005)
2014Randomized trialPMID 23999198DOIregistry reference BACKGROUND:23999198