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

Completed

• Conditions: Obesity
• Interventions: Drug: liraglutide 3.0 mg

• Registration Number: NCT02773355
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-13
• Study Start: 2016-05-16
• Study First Posted: 2016-05-16
• Primary Completion: 2021-11-30
• Study Completion: 2022-02-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Saxenda®	liraglutide 3.0 mg	-

Primary Outcome Measures

Name	Time	Method
Frequency of pancreatitis	Year 0-3

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions (ADR)	Year 0-3

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇲🇽 Puebla, Mexico