GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects

A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects

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 ≤35•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 IDNCT03144271

Org study IDNN9535-1820

Secondary ID2007-000303-15

Secondary IDU1111-1193-6996World Health Organization (WHO)

Timeline

Milestones

Study start2007-06-11actual

Primary completion2007-10-08actual

Study completion2007-10-08actual

Study first posted2017-05-08actual

Last update posted2017-05-08actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)

•Subject is male

•Age 18-65 years, both included

•Body Mass Index (BMI) below 35.0 kg/m^2 (Body weight between 50 kg -150 kg, both inclusive)

•Good general health based on medical history, physical examination including ECG (Electrocardiogram) and laboratory analysis, as judged by the investigator

Exclusion criteria

•Previous participation, defined as randomised, in any other clinical trial involving this or other investigational products within the last 3 months before dosing

•Patients with MI (Myocardia-Infarction) during the last 12 month

•Patients receiving ACE (Angiotensin-Converting Enzyme) inhibitors, beta-blockers, thiazide diuretics, thyroid hormones, and/or lipid lowering medication who are not on a stable dose for more than 6 weeks prior to start of the study

•Use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine)

•Clinically significant GI (Gastro-Intestinal) disease including inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia, apparent diabetic gastro paresis, diabetic diarrhoea, or surgery of the gastro-intestinal tract (except appendectomy and cholecystectomy)

•Subjects who are sexually active and have not been surgically sterilised must be informed that they and their partner use a highly effective method of contraception (Pearl Index below 1%) such as implants, injectables, combined oral contraceptives, or hormonal IUDs (intrauterine devices), or refrain from sexual intercourse during the study and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by study medication

•Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers, and MAO (Mono-Amino-Oxidase) inhibitors

•Subjects who drink more than 8 cups of tea/coffee per day

•History of drug or alcohol abuse (defined as intake of more than 28 units weekly - 1 unit = 12 oz or 360 ml of beer; 5 oz ir 150 ml of wine; 1.5 oz or 45 ml of distilled spirits)

•Alcohol intake within 48 hours prior to dosing

•Evidence of drug abuse on urine testing and serum at study entry

•The subject smokes 7 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the dosing day and during the confinement period

•Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV-positive

•Impaired hepatic function measured as ALAT (Alanine aminotransferase), ASAT (Aspartate aminotransferase), alkaline phosphatase above three times the upper reference limit (one retest within one week is permitted, the last result being conclusive)

•Clinical significant abnormal laboratory test results during the screening as judged by the Investigator

•Impaired renal function, defined as s-creatinine above or equal to 135 μmol/L (=1.5mg/dL) (one retest within one week is permitted, the last result being conclusive)

•Cardiac problems defined as: decompensated heart failure (NYHA (New York Heart Association) class III and IV) at any time and/or angina pectoris and/or myocardial infarction within the last 12 months

•Blood pressure in supine position at the screening examination above 160 mmHg systolic or 90 mmHg diastolic or heart rate outside the range of 50 - 90 bpm

•Known or suspected allergy to trial product or related products

•History of significant drug allergy or drug hypersensitivity

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

•Blood donation or considerable blood loss - more than 500 mL, during the 3 months prior to study start

•Any condition that the investigator and / or sponsor feels would interfere with study participation or evaluation of results

•Use of non-prescription drugs, except routine vitamins, within 1 week prior to the dose of the test drug. Occasional use of paracetamol is permitted

•Subjects who have taken part in strenuous exercise within 4 days prior to trial start, due to interference with the hepatic microsomal mono-oxygenase system. The evaluation whether strenuous exercise has been undertaken will be evaluated by the Investigator, and strenuous exercise is not allowed during the trial

Endpoints (6)

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

Glycemic / diabetes

Safety / tolerability / PK

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Morning fasting plasma glucose

Time frame:At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Morning fasting insulin

Time frame:At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)

descriptive

Secondary/protocol endpoint

Morning fasting glucagon

Time frame:At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)

descriptive

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Number of Adverse Events

Time frame:After 24-33 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the curve of NNC 0113-0217

Time frame:From 0-48 hours after dosing

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the curve of NNC 0113-0217

Time frame:From 0-168 hours after dosing

AUC₀–∞

concentration, 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.