A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects

NCT02161588 · Completed

Last updated 2026-05-28

This trial tests how a diabetes medication called semaglutide is absorbed, processed, and tolerated in the bodies of healthy Japanese and Caucasian men.

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 48 people

Who can join Ages 20–55 · male only Healthy volunteers accepted.

Timeline Started 2014-06 · est. completion 2014-11

Where 1 site · Japan

What this study is testing ClinicalTrials.gov NCT02161588 ↗

Description as written by the study sponsor.

This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.

Treatments tested

semaglutide Drug

Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively.
placebo Drug

Once-daily oral administration as tablets.

Main thing measured	Area under the semaglutide plasma concentration-time curve
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2, Healthy
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02161588 ↗