Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 2, Healthy

In brief

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.

Key facts

Study ID

NCT01473953

Run by

Novo Nordisk A/S

People needed

31

Starts

2011-10-01

Expected to finish

2012-03-01

Last updated by the study team

2017-03-23

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index (BMI) between 20 and 35 kg/m\^2 (both inclusive) with a body weight of at least 60 kg
• Apart from being obese (BMI above 30 kg/m\^2) the subject has to be considered generally healthy

You may not qualify if…

• Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
• Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy
• Prescription medicine and non-prescription medicine with few exceptions
• Current and prior history of alcohol or drug abuse
• Current smoking of more than 5 cigarettes per day
• Mental incapacity, language barriers, or unwillingness to comply with the protocol

Where it is running

• Novo Nordisk Investigational Site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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