Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

NCT01866748 · Completed

Last updated 2026-05-28

This clinical trial tested the safety, tolerability, and how the body processes different doses of an oral version of the diabetes medication semaglutide in healthy adult 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 170 people

Who can join Ages 18–64 · male only Healthy volunteers accepted.

Timeline Started 2013-05 · est. completion 2014-04

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT01866748 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.

Treatments tested

semaglutide Drug

A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.
semaglutide Drug

Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts.
placebo Drug

In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.
placebo Drug

In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C).

Main thing measured	Part A: Number of treatment emergent adverse events (TEAEs)
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 NCT01866748 ↗