Study S001384

Prospective Cohort Study to Evaluate the Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Persons With Obesity Without Diabetes and Type 2 Diabetes Mellitus With or Without Obesity in Paraguay.

ClinicalTrials.gov record

Registration

Registration: NCT07588438
Acronym: REAL-TIRZEPY
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: RECRUITING
Enrollment: 160
Start: 2026-07-27
Primary completion: 2027-08-10
Lead sponsor: Las Rías Medical Center
Conditions: Obesity; Diabetes Mellitus, Type 2
Interventions: DRUG:Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.)
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Mean Percent Change From Baseline in Body Weight at 52 Weeks. [Baseline and 52 weeks.]
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 52 Weeks. [Baseline and 52 weeks.]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs). [Through week 52.]

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