Spartina® (Tirzepatide) Effectiveness and Safety Evaluation

CinnaGen

Status: Enrolling

Conditions: Obesity & Overweight

Study type: Observational

Funder types: Industry

Identifiers

NCT07262762

TIR.CIN.AE.IV.04

Details and patient eligibility

About

The goal of this study is to evaluate Effectiveness and safety of Spartina® (Tirzepatide) in male or female participants with obesity and overweight. The main questions which are aimed to be answered:

1. Is Spartina® (Tirzepatide) effective in the treatment of obesity and overweight?
2. Is Spartina® (Tirzepatide) safe in the treatment of obesity and overweight?

In this study, there is no comparison group. Participants receive Spartina® (Tirzepatide)

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥18 years of age
2. Willingness for signing and having signed the informed consent form
3. BMI ≥30 kg/m² or ≥27 kg/m² with ≥1 weight-related comorbidity

Exclusion criteria

1. Prior use of any GLP-1 agonist in the last 6 months
2. Type 1 diabetes mellitus
3. Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data
4. Pregnancy or breast-feeding
5. Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)