None listed
Conditions
Brief summary
Obesity is a chronic condition associated with significant global morbidity and mortality. The effectiveness and safety of tirzepatide, a new dual agonist of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors, remain uncertain in individuals with obesity in Greece. This study explores whether tirzepatide, a new medication, is safe and effective in helping individuals with obesity in Greece achieve better health outcomes.
Interventions
One-arm intervantional study. Patients with obesity , Body Mass Index (BMI) of 30 or more, or 27 or more and at least one weight-related complication, will be treated with tirzepatide , a dual agonist for the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. Administration: Once weekly via subcutaneous injection (SQ- self-administered by patient) with incremental dosage adjustments:The initial dosage of tirzepatide for treatment initiation will be 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. Thereafter, the dose will ne escalated by 2.5 mg after at least 4 weeks on its dose. The maximum tirzepatide dosage will be 15 mg SQ once weekly.The total duration of tirzepatide administration for each participant will be 1 year. Patients who will be unable to tolerate the dose escalation will continue on the maximum previously tolerated dose for the remainder of the study period. Adherence to the intervention will be based on self-reporting by the participants.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients with obesity (BMI; the weight in kilograms divided by the square of the height in meters, of 30 or more, or 27 or more and at least one weight-related complication):e.g., hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
Exclusion criteria
A change in body weight of more than 5 kg within 90 days before screening, previous or planned surgical treatment for obesity, and treatment with a medication that promotes weight loss within 90 days before screening.