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Not yet recruiting

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

Effectiveness and Safety of Tirzepatide (t.g.) in Patients Treated at the Obesity Unit of the Department of Endocrinology of the Hospital de Clínicas, Faculty of Medical Sciences, UNA: Phase 4 Study

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

300

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥27

Primary endpoint

Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07492563
Org study IDTG-PY-001

Timeline

Milestones

Study first posted2026-03-25actual
Last update posted2026-03-25actual
Study start2026-03estimated (month precision)
Primary completion2026-10estimated (month precision)
Study completion2027-10estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Patients who attend the Endocrinology Unit of Hospital de Clínicas, Universidad Nacional de Asunción, Paraguay

Inclusion criteria

Age ≥18 years
BMI ≥27 kg/m² with weight-related comorbidities OR BMI ≥35 kg/m²
Clinical indication for tirzepatide per treating physician
Paraguayan citizenship or permanent residence
Residence in Asunción or Metropolitan Area or possibility to assist to regular visits
Ability to attend visits for 12 months
Ability to provide written informed consent

Exclusion criteria

Type 1 diabetes or secondary diabetes
Known hypersensitivity to tirzepatide
Personal or family history of medullary thyroid carcinoma or MEN 2 syndrome
Acute pancreatitis in last 12 months or chronic pancreatitis
Severe gastrointestinal disease
Bariatric surgery in last 12 months
Pregnancy or breastfeeding
Severe renal impairment (eGFR <30 mL/min/1.73m²)
Severe hepatic impairment (Child-Pugh B or C)
Unstable cardiovascular disease
Active cancer (except non-melanoma skin cancer completely resected)
Current use of other GLP-1 receptor agonists
Participation in another interventional trial within 30 days

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
2
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in Body Weight

Time frame:12 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:12 months

BMI, change

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in systolic and diastolic blood pressure

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in total cholesterol, HDL cholesterol, tryglicerides

Time frame:12 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Incidence of Adverse Events

Time frame:12 months

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Reasons for treatment discontinuation

Time frame:12 months

Discontinuation due to AE

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.