A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

A Randomised, Single Centre, Double-blind, Incomplete Block Trial to Test for Equivalence Between Subcutaneous Injections of the GLP-1 Analogue NN9535 in 1 mg/ml, 3 mg/ml and 10 mg/ml Concentrations in Healthy Male Subject

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813020

Enrollment

Registered

2008-12-22

Start date

2009-01-31

Completion date

2009-04-30

Last updated

2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.

Interventions

DRUGsemaglutide

Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator * Body weight between 80 kg and 110 kg (both inclusive) * Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive * Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)

Exclusion criteria

* Known or suspected allergy to trial product(s) or related products * Previous participation in this trial (randomisation) * The receipt of any investigational medicinal product within 3 months prior to this trial * Subjects who have had a clinically relevant illness within 4 weeks of dosing * History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders * Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period

Design outcomes

Primary

Measure	Time frame
AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration	a 28 day time period

Secondary

Measure	Time frame
Cmax of the plasma NN9535 curve	a 28 day time period

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026