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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide-depot; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473953

NN9223-3928

U1111-1123-0547 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 5 patient groups, including a placebo group

Cohort 1a: Lira-depot 2.25 mg

Experimental group

Treatment:

Drug: liraglutide-depot

Cohort 2a: Lira-depot 6.75 mg

Experimental group

Treatment:

Drug: liraglutide-depot

Cohort 3a: Lira-depot 15 mg

Experimental group

Treatment:

Drug: liraglutide-depot

Cohort 4a: Lira-depot 30 mg

Experimental group

Treatment:

Drug: liraglutide-depot

Placebo

Placebo Comparator group

Treatment:

Drug: placebo