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

• Status: Enrolling by invitation
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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 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