GLP-1 Peptide Atlas, by Delfa

Completed

A Regulatory Post-marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda®(Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea.

Prospective, Multicentre, Open-label, Single-arm, Non-interventional Regulatory Post-marketing Surveillance(rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda® (Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

758

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03560336

Org study IDNN8022-4380

Secondary IDU111-1199-8606World Health Organization (WHO)

Timeline

Milestones

Study first posted2018-06-18actual

Study start2018-07-05actual

Primary completion2020-12-02actual

Study completion2020-12-02actual

Last update posted2021-07-09actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Obese patients and overweight patients with obesity-related comorbidities

Eligibility criteria

•The decision to initiate treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician before and independently from the decision to include the patient in this study - Informed consent obtained before any study-related activities Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Male or Female of Native Korean, age greater than or equal to 18 years who is scheduled to start treatment with Saxenda® based on the clinical judgment of physician as specified in the Korean-Prescribing Information (local label) Exclusion Criteria: - Patients who are or have previously been on Saxenda® therapy - Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Treatment with any investigational drug within 30 days prior to enrolment into the study - Female patient who is pregnant, breast-feeding, or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

8 endpoints

Secondary/protocol endpoint

Body weight loss (%) from week 0 to week 13

Time frame:Week 0, week 13

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body weight loss (%) from week 0 to week 26

Time frame:Week 0, week 26

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body weight loss (kg) from week 0 to week 13

Time frame:Week 0, week 13

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body weight loss (kg) from week 0 to week 26

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

The proportion of patients losing at least 5% of week 0 body weight at week 13

Time frame:Week 0, week 13

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

The proportion of patients losing at least 5% of week 0 body weight at week 26

Time frame:Week 0, week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

The proportion of patients losing more than 10% of week 0 body weight at week 13

Time frame:Week 0, week 13

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

The proportion of patients losing more than 10% of week 0 body weight at week 26

Time frame:Week 0, week 26

≥10% weight-loss responders

threshold achievement, improvement

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Incidence of adverse events (AEs) by preferred term (PT)

Time frame:From baseline to week 13 (± 3 weeks)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Incidence of adverse events (AEs) by preferred term (PT)

Time frame:From baseline to week 26 (± 3 weeks)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of adverse drug reaction (ADRs)

Time frame:From baseline to week 13 (± 3 weeks)

event count, event

Secondary/protocol endpoint

Number of adverse drug reaction (ADRs)

Time frame:From baseline to week 26 (± 3 weeks)

event count, event

Secondary/protocol endpoint

Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)

Time frame:From baseline to week 13 (± 3 weeks)

Serious AEs (any)

event count, event

componentsSerious AEs (any)

Secondary/protocol endpoint

Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)

Time frame:From baseline to week 26 (± 3 weeks)

Serious AEs (any)

event count, event

componentsSerious AEs (any)

Secondary/protocol endpoint

Number of unexpected AEs and unexpected ADRs

Time frame:From baseline to week 13 (± 3 weeks)

event count, event

componentsTreatment-emergent AEs (any)

Secondary/protocol endpoint

Number of unexpected AEs and unexpected ADRs

Time frame:From baseline to week 26 (± 3 weeks)

event count, event

componentsTreatment-emergent AEs (any)

Secondary/protocol endpoint

Number of unexpected SAEs and unexpected SADRs

Time frame:From baseline to week 13 (± 3 weeks)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of unexpected SAEs and unexpected SADRs

Time frame:From baseline to week 26 (± 3 weeks)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Dose of liraglutide after administration initiation

Time frame:week 13 (± 3 weeks)

descriptive

Secondary/protocol endpoint

Dose of liraglutide after administration initiation

Time frame:week 26 (± 3 weeks)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.