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

NCT02773355 | Completed

• 2 other identifiers: NN8022-4210U1111-1170-6497
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 14

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Frequency of pancreatitis

  Year 0-3

Secondary Outcomes (1)

• Adverse drug reactions (ADR)

  Year 0-3

Study Arms (1)

Saxenda®

Drug: liraglutide 3.0 mg

Interventions

liraglutide 3.0 mg DRUG

Patients will be treated with commercially available Saxenda® prescribed according to routine clinical practice at the discretion of the treating physician.

Saxenda®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The medical condition investigated in this study is obesity and overweight with one or more weight related comorbidities. The study will aim at observing all patients exposed to Saxenda® during treatment by the 20 participating physicians in Mexico.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (14)

Especialidades Médicas del Bosque

Guadalajara, Jalisco, 44520, Mexico

Location

Investigación Clínica Especializada, S.C.

Guadalajara, Jalisco, 44600, Mexico

Location

Centro de Investigacion Clinica Endocrinologica de Jalisco

Guadalajara, Jalisco, 44670, Mexico

Location

Unidad Médica Dentistas

Guadalajara, Jalisco, 44679, Mexico

Location

Hospital Bite Medica

Mexico City, México, D.F., 01330, Mexico

Location

Hospital San Angel Inn

Mexico City, México, D.F., 03339, Mexico

Location

Hospital HMG Coyoacan

Mexico City, México, D.F., 04380, Mexico

Location

Hospital San Angel Inn_Mexico City

Mexico City, México, D.F., 06700, Mexico

Location

Torre Médica Dalinde

Mexico City, México, D.F., 06760, Mexico

Location

Zrii de México Ejecutivo Independiente

Monterrey, Nuevo León, 66220, Mexico

Location

Hospital CIMA Hermosillo

Hermosillo, Sonora, 83270, Mexico

Location

Hospital Angeles de las Lomas

México, State of Mexico, 52763, Mexico

Location

Medica Sur

Mexico City, 14050, Mexico

Location

Hospital Angeles de Puebla

Puebla City, 72190, Mexico

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 16, 2016
• Study Start: May 16, 2016
• Primary Completion: November 30, 2021
• Study Completion: February 28, 2022
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ME (14)