Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients

Novo Nordisk

Status: Completed

Conditions: Obesity

Treatments: Drug: liraglutide 3.0 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT02773355

NN8022-4210

U1111-1170-6497 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
• The decision to initiate the treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
• Obese patients (BMI equal to or above 30 kg/m^2) or overweight patients (BMI Equal to or above 27 kg/m^2) with at least one weight related comorbidity according to Saxenda® label text in Mexico
• Age equal or above 18 years at the time of signing informed consent

Exclusion criteria

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Hypersensitivity to Saxenda® or to any of its excipients
• Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
• Diagnosis of type 1 diabetes

Trial design

27 participants in 1 patient group

Saxenda®

Treatment:

Drug: liraglutide 3.0 mg