Completed

Safety and Tolerability Assessment of Ascending Single Subcutaneous Doses of NNC 0113-0217 in Healthy Male Subjects

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Study Aim

This study aims to evaluate the safety and tolerability of increasing single subcutaneous doses of NNC 0113-0217 in healthy male participants, primarily by monitoring the number of adverse events.

What is being tested

semaglutide

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 65 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: June 2007
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: June 11, 2007

Actual date on which the first participant was enrolled.

This clinical trial focuses on a drug called NNC 0113-0217. The main goal is to test how safe and well-tolerated this drug is when given as a single dose under the skin to healthy male participants. The trial takes place in Europe and aims to find the highest dose that can be given without causing unacceptable side effects, also known as the Maximum Tolerated Dose (MTD). This study is important as it helps to understand the safety profile of NNC 0113-0217, which is a crucial step in developing new treatments. During the trial, participants receive either NNC 0113-0217 or a placebo, a substance that looks like the drug but contains no active ingredients. This is a 'double-blind' trial, meaning neither the participants nor the researchers know who receives the drug or the placebo. The study measures the number of adverse events or side effects to evaluate the safety of the drug. As this is a phase 1 trial, it is one of the first times the drug is tested in humans, with a primary focus on safety.

Official TitleA Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects
NCT03144271
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

58 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 18 to 65 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

5 inclusion criteria required to participate
Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Subject is male
Age 18-65 years, both included
Body Mass Index (BMI) below 35.0 kg/m^2 (Body weight between 50 kg -150 kg, both inclusive)
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25 exclusion criteria prevent from participating
Patients with MI (Myocardia-Infarction) during the last 12 month
Previous participation, defined as randomised, in any other clinical trial involving this or other investigational products within the last 3 months before dosing
Patients receiving ACE (Angiotensin-Converting Enzyme) inhibitors, beta-blockers, thiazide diuretics, thyroid hormones, and/or lipid lowering medication who are not on a stable dose for more than 6 weeks prior to start of the study
Use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine)
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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
Dose-escalation trial

Group II

Placebo
Dose-escalation trial

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

Neuss, GermanyOpen Novo Nordisk Investigational Site in Google Maps
CompletedOne Study Center