DelfaGLP-1 Atlas

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CompletedPhase 4Results posted

Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

A Trial to Complare the Injection Site Pain Experience of Semaglutide 0.25 mg and Dulaglutide 0.75 mg Administered sc

Lead sponsor

Novo Nordisk A/S

Assets

Dulaglutide / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

104

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI ≥25•Healthy volunteers

Primary endpoint

•Intensity of Injection Site Pain

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 IDNCT04189848
Org study IDNN9535-4648
Secondary ID2019-83003844-57European Medicines Agency (EudraCT)
Secondary IDU1111-1241-0348World Health Organization (WHO)

Timeline

Milestones

Study start2019-12-03actual
Study first posted2019-12-06actual
Primary completion2020-01-29actual
Study completion2020-02-27actual
Results first posted2021-02-17actual
Last update posted2022-11-07actual

Assets

Investigational agents

DulaglutideSemaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
•Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
•Body mass index equal to or above 25.0 kg/m^2.
•Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the Investigator.

Exclusion criteria

•Known or suspected hypersensitivity to trial product(s) or related products.
•Previous participation in trial INS-4603, INS-4582 or NN9535-4648. Participation is defined as having received investigational product.
•Female who is pregnant, breast-feeding or intends to become pregnant within 4 weeks of Day 1 or is of childbearing potential and not using highly effective contraceptive methods.
•Participation in a drug study within 60 days prior to drug administration in the current trial OR participation in more than 4 other drug studies in the 12 months prior to drug administration in the current trial.
•Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
•Glycosylated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
•Supine blood pressure at screening (after resting for 5 minutes or longer) outside the range of 90-160 mmHg for systolic or 45-89 mmHg for diastolic.
•Supine pulse rate (as part of vital signs) outside the range of 40-100 beats/min after resting for 5 minutes or longer at screening.
•Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives and occasional use of paracetamol (not allowed within 24 hours prior to drug administration), within 14 days prior to Day 1.
•Diagnostic test results positive for HIV-1 or HIV-2 infection.
•Diagnostic test results positive for active hepatitis B or hepatitis C infection.
•Mental incapacity, language barriers, or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the trial as judged by the Investigator.
•Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
•Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre.
•Use of tobacco and nicotine products, defined as any of the below:
•Smoking more than 1 cigarette or the equivalent per day on average.
•Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period.
•Blood donation, plasma donation, or blood draw
•In excess of 400 mL within the past 90 days prior to the day of screening
•In excess of 50 mL within the past 30 days prior to the day of screening
•Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
•Subjects with a history of malignant neoplasms within the past 5 years prior to screening will be excluded from the trial.
•Presence or history of pancreatitis (acute or chronic; as declared by the subject or reported in the medical records).
•Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the trial requirements.
•Subject depends on the Sponsor, the Investigator, or the study centre, or subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the trial.
•Vulnerable subject (e.g. person kept in detention) who may have an increased likelihood of being wronged or of incurring additional harm.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints
Primary/registry result

Intensity of Injection Site Pain

Time frame:1 minute after each injection (Day 1)

descriptive

Posted result

GroupValue (mean), Score on a scale95% CI
Semaglutide5.6—
Dulaglutide11.5—
Treatment difference-5.995% CI-8.2 – -3.6p<0.0001ANOVA
Primary/protocol endpoint

Intensity of Injection Site Pain

Time frame:1 minute after each injection (Day 1)

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.