ObesityNCT02773355
Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
An observational study of Obesity, run by Novo Nordisk A/S at 14 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- liraglutide 3.0 mg
- How many people
- 27 participants
- Where
- 14 sitesMexico
- Study dates
- 16 May 2016to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
Mexico14 sites
Especialidades Médicas del Bosque
Guadalajara, Jalisco, 44520
Investigación Clínica Especializada, S.C.
Guadalajara, Jalisco, 44600
Centro de Investigacion Clinica Endocrinologica de Jalisco
Guadalajara, Jalisco, 44670
Unidad Médica Dentistas
Guadalajara, Jalisco, 44679
Hospital CIMA Hermosillo
Hermosillo, Sonora, 83270
Hospital Angeles de las Lomas
México, State of Mexico, 52763
Hospital Bite Medica
Mexico City, México, D.F., 01330
Hospital San Angel Inn
Mexico City, México, D.F., 03339
Hospital HMG Coyoacan
Mexico City, México, D.F., 04380
Hospital San Angel Inn_Mexico City
Mexico City, México, D.F., 06700
Torre Médica Dalinde
Mexico City, México, D.F., 06760
Medica Sur
Mexico City, 14050
Zrii de México Ejecutivo Independiente
Monterrey, Nuevo León, 66220
Hospital Angeles de Puebla
Puebla City, 72190
About this study
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
- Being tested
- liraglutide 3.0 mg
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutide 3.0 mgDrug
Patients will be treated with commercially available Saxenda® prescribed according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Saxenda® | Not described Receives: Drug: liraglutide 3.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pancreatitis
Measured: Year 0-3
Secondary outcomes (1)
Adverse drug reactions (ADR)
Measured: Year 0-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start16 May 2016
- Primary completion30 Nov 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773355
- Sponsor's protocol ID
- NN8022-4210
- Other IDs
- U1111-1170-6497
- Status last verified
- Apr 2026
- First submitted
- 13 May 2016
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
- ClinicalTrials.gov ID
- NCT02773355
- Acronym / sponsor ID
- NN8022-4210
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 May 2016 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saxenda® | – | Drug: liraglutide 3.0 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutide 3.0 mgPatients will be treated with commercially available Saxenda® prescribed according to routine clinical practice at the discretion of the treating physician. | Drug | Saxenda® |
Primary outcome
Frequency of pancreatitis
Time frame: Year 0-3
1 secondary outcome
Adverse drug reactions (ADR)
Time frame: Year 0-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Novo Nordisk A/S at 14 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of pancreatitis (time frame: Year 0-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.