GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects

A Randomised, Double Blind, Placebo-controlled, Parallel-group, Multiple Doses, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Profiles of NN9535 in Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous Injections.

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18.5-24.9•HbA1c ≤6%•Male

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 IDNCT00851773

Org study IDNN9535-3633

Secondary ID2008-006325-13

Timeline

Milestones

Study first posted2009-02-26estimated

Last update posted2015-02-23estimated

Study start2009-02 (month precision)

Primary completion2009-10actual (month precision)

Study completion2009-10actual (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years

Maximum age45 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•For Caucasian or Japanese volunteers the following applies:

•Informed consent obtained before any trial-related activities

•Body weight between 54 and 90 kg (both inclusive)

•Body mass index (BMI) between 18.5 and 24.9 kg/m2 (both inclusive)

•HbA1c below 6.0 %

•Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator

•Subjects who are sexually active and have partners who are or could be pregnant are willing and required to use a barrier method of contraception (e.g. condom) for the duration of the study and for 90 days following the last dose of study medication

•Japanese passport holder, Japanese-born parents, lived outside Japan for 5 years or less

Exclusion criteria

•Any clinical laboratory values deviating from or outside the laboratory reference range unless considered not to be clinically significant by the investigator

•Any abnormal ECG findings at the screening, considered to be clinically significant by the Investigator

•Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, considered to be clinically significant by the Investigator

•Previous randomised in this trial (not applicable for stand-by volunteers)

•Blood pressure in supine position at the screening, after resting for 5 min, and in the standing position after standing for 1 min, consistently outside the ranges 90 - 140 mmHg systolic or 40 - 90 mmHg diastolic

•Heart rate in supine position at the screening, after resting for 5 min, consistently above 100 beats/min

•Alcohol intake within 48 hours prior to the screening and admission (examined by alcohol breath test)

•Hepatitis B surface antigen, Hepatitis C antibodies or Human Immunodeficiency Virus (HIV) antibodies positive

•History of significant allergy or hypersensitivity

•Known or suspected allergy to trial product or related products

•History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 21 units (U) weekly: One unit of alcohol equals 1/2 pint (approximately 250 mL) of beer or lager, or one glass of wine or Japanese sake, or 1/6 gill (approximately 20 mL) of spirits)

•Subjects who smoke more than 10 cigarettes, or the equivalent, per day or is unwilling to refrain from smoking whenever required for the trial procedure

•Use of prescription drugs within 3 weeks prior to dosing, non-prescription drugs within 1 week prior to dosing except for vitamins, minerals and nutritional supplements

•Received any investigational drug within 12 weeks prior to the planned first dosing

•Subjects who have taken part in strenuous exercise within 48 hours prior to first dosing, due to interference with the hepatic microsomal monooxygenase system. The Investigator or Sub-Investigator will evaluate whether strenuous exercise has been undertaken

•Loss of more than 400 mL blood in total within the last 12 weeks or more than 200 mL blood in total within the last 4 weeks prior to first dosing

•Subjects with a first-degree relative with diabetes mellitus

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

•Possibility that the subject will not comply with the protocol

•Subjects who in the opinion of the Investigator or Sub-Investigator should not participate in the trial

•Subjects with known history of either Type 1 or Type 2 diabetes mellitus are excluded

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

Safety / tolerability / PK

Cardiometabolic biomarkers

Other (unclassified)

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Vital signs (blood pressure and pulse)

Time frame:at all scheduled visits (2 - 14) including screening (visit 1)

descriptive

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Adverse events

Time frame:at all scheduled visits (2 - 14) following screening

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Frequency of hypoglycaemic episodes

Time frame:at all scheduled visits (2 - 14) following screening

event count, event

Secondary/protocol endpoint

12-lead ECG (electrocardiogram)

Time frame:at all scheduled visits (2 - 14) including screening (visit 1)

descriptive

Secondary/protocol endpoint

Haematology

Time frame:at all scheduled visits (2 - 14) including screening (visit 1)

descriptive

Secondary/protocol endpoint

Urinalysis

Time frame:at all scheduled visits (2 - 14) including screening (visit 1)

descriptive

Secondary/protocol endpoint

Calcitonin

Time frame:at screening (visit 1) and at visits 2, 9 and 14

Thyroid event

descriptive

Secondary/protocol endpoint

Antibody development against N9535

Time frame:at visits 2 and 14

Immunogenicity (ADA)

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Biochemistry

Time frame:at all scheduled visits (2 - 14) including screening (visit 1)

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.