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

NCT00851773 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and side effects of the drug NN9535 in healthy adult men of Japanese and Caucasian backgrounds.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 84 people

Who can join Ages 20–45 · male only

Timeline Started 2009-02 · est. completion 2009-10

Where 1 site · United Kingdom

What this study is testing ClinicalTrials.gov NCT00851773 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.

Treatments tested

semaglutide Drug

0.1 mg once weekly, s.c. injection
semaglutide Drug

0.2 mg once weekly, s.c. injection
semaglutide Drug

0.4 mg once weekly, s.c. injection
semaglutide Drug

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
semaglutide also known as NN9535 Drug

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection
placebo Drug

0.1 mg once weekly, s.c. injection
placebo Drug

0.2 mg once weekly, s.c. injection
placebo Drug

0.4 mg once weekly, s.c. injection
placebo Drug

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
placebo Drug

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection

Main thing measured	Adverse events
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Healthy
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00851773 ↗