Completed

Safety and Tolerability of NNC 90-1170 in Healthy Japanese Males

Study Aim

This phase 1 study aims to evaluate the safety and tolerability of NNC 90-1170 in healthy Japanese males, by monitoring adverse events, body weight, ECG (ElectroCardioGram), and vital signs such as blood pressure and pulse rate.

What is being tested

liraglutide

+ placebo

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 20 to 45 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1

Interventional

Study Start: December 2002

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2002

Actual date on which the first participant was enrolled.

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.

Official TitleA Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 90-1170 in Healthy Japanese Male Subjects

NCT01620463

Principal SponsorNovo Nordisk A/S

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

1 inclusion criteria required to participate

Body Mass Index (BMI) between 18 and 27 kg/m^2, inclusive

11 exclusion criteria prevent from participating

Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator or Sub-Investigator

Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the Investigator

Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmHg systolic or 40-90 mmHg diastolic

Heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Novo Nordisk Investigational Site

Tokyo, JapanOpen Novo Nordisk Investigational Site in Google Maps

CompletedOne Study Center