Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay

Sponsor
LABORATORIOS INDUFAR
Study ID
NCT07492563
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide (T.G.) — DRUG
    Subcutaneous injection once weekly Dose escalation: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg Duration: 12 months

Study Details

This is a Phase 4 observational study evaluating the safety and effectiveness of tirzepatide (T.G.) manufactured by INDUFAR S.A. in 300 patients with obesity treated at the Obesity Unit of Hospital de Clínicas in Paraguay over 12 months. The primary objective is to assess the safety profile through monitoring adverse events. Secondary objectives include evaluating weight loss, metabolic parameters improvement, and treatment satisfaction in real-world clinical practice.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Tirzepatide Treatment Group
    All enrolled patients receiving tirzepatide according to clinical indication

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: 12 months ]

Central Contacts

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