Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01272973

Enrollment

Registered

2011-01-10

Start date

2011-01-31

Completion date

2011-07-31

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, Healthy

Brief summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects

Interventions

DRUGsemaglutide

Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.

DRUGplacebo

Placebo (oral) administered once daily for 10 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Healthy male subjects, based on an assessment of medical history, physical examination and * BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion criteria

* Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner * Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological * The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events (AEs)	from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

Secondary

Measure	Time frame
Hypoglycaemic episodes	from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Laboratory safety variables (haematology, biochemistry, and urinalysis)	from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
Maximum plasma concentration of NN9924	after dosing on the 68th, 69th and 70th Day
Area under the plasma concentration curve over the dosing interval (0-24 hours)	after dosing on the 68th, 69th and 70th day
Terminal phase elimination half-life	from last dose (day 70) to follow-up visit 91-105 days after first dose

Countries

Germany

Outcome results

None listed

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