GLP-1 Peptide Atlas, by Delfa

Active not recruiting

Special Use - Results Surveillance on Long-term Use With Wegovy®

A Multi-centre, Prospective, Non-interventional, Single-armed, 104 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Wegovy® Once Weekly in Patients With Obesity Disease Under Real-world Clinical Practice Conditions

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

112

Recruiting sites

—

Enrollment

1,071

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

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 IDNCT06283667

Org study IDNN9536-4872

Secondary IDU1111-1266-3863World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-02-28actual

Study start2024-06-11actual

Last update posted2026-04-22actual

Primary completion2028-01-31estimated

Study completion2028-01-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

SexAll

Sampling methodNon probability sample

Study population text

Participants are patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.

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 Wegovy® 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

•Male or female, no age limitation

•Diagnosis of obesity disease; with either hypertension, dyslipidaemia or type 2 diabetes, insufficiently controlled with diet and exercise therapies, and should meet either of:

1. Body mass index (BMI)* greater than or equal to 27 kilograms per meter square (kg/m^2) with two or more obesity-related comorbidities**, or

2. BMI* greater than or equal to 35 kg/m^2

•Participant who has never been exposed to Semaglutide or who started treatment with Wegovy® within the past 4 weeks at registration

–BMI calculation will be based on height and body weight recorded in the enrolment form of electronic case report form (eCRF) at enrolment.

–Definition of obesity-related comorbidities are in accordance with Japan Student Services Organization (JASSO) guideline 3: (1) impaired glucose tolerance, (2) dyslipidaemia, (3) hypertension, (4) hyper-uricemia/gout, (5) coronary artery disease, (6) cerebral infarction, (7) non-alcoholic fatty liver disease, (8) menstrual disorder/infertility, (9) obstructive sleep apnoea syndrome/obesity-hypoventilation syndrome, (10) locomotory disease or (11) obesity-related kidney disease.

Exclusion criteria

•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 baseline (Visit 1)

•Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

•A history of hypersensitivity to any ingredients of this drug

•Diabetic ketoacidosis, diabetic coma, pre-coma or type 1 diabetes mellitus [The treatment with insulin is mandatory. It is not appropriate to use this drug]

•In emergency cases such as severe infections and surgery in patients with type 2 diabetes [It is desirable to control blood glucose with insulin; therefore, administration of this drug is not appropriate]

•Pregnant or possibly pregnant female

•Female who plans to become pregnant within 2 months

Endpoints (9)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Change in body weight (Percent (%))

Time frame:From baseline (week 0) to end of study (week 104)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (Kilograms (Kg))

Time frame:From baseline (week 0) to end of study (week 104)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of study (week 104)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI (Body Mass Index)

Time frame:From baseline (week 0) to end of study (week 104)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight after treatment discontinuation

Time frame:From treatment discontinuation after at least 12 weeks to end of study (week 104)

Body weight, % change

percent change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Adverse Reactions (ARs)

Time frame:From baseline (week 0) to end of study (week 104)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Adverse Events (AEs)

Time frame:From baseline (week 0) to end of study (week 104)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of serious adverse events (SAEs)

Time frame:From baseline (week 0) to end of study (week 104)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Reactions (SARs)

Time frame:From baseline (week 0) to end of study (week 104)

Serious AEs (any)

event count, event

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.