Safety and Tolerability of Liraglutide in Healthy Male Volunteers

NCT01507272 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and tolerability of the drug liraglutide 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 34 people

Who can join Ages 18–45 · male only

Timeline Started 1999-03 · est. completion 1999-12

Where 1 site · United Kingdom

What this study is testing ClinicalTrials.gov NCT01507272 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).

Treatments tested

liraglutide also known as NNC 90-1170 Drug

Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
liraglutide also known as NNC 90-1170 Drug

Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg
placebo Drug

Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
placebo Drug

Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order

Main thing measured	AUC (area under the curve)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Healthy
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01507272 ↗