Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: placebo

Drug: liraglutide

Drug: NNC9204-0530

Study type

Interventional

Funder types

Industry

Identifiers

NCT02235961

U1111-1151-0761 (Registry Identifier)

NN9030-4111

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses of NNC9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects.

Enrollment

163 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male, age between (both inclusive) 18 and 55 years at the time of signing inform consent
Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m^2

Exclusion criteria

Thyroid stimulating hormone values outside 0.4-6.0 mIU/l
HbA1c (glycated hemoglobin) above or equal to 6.5%
Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval corrected by Fridericia formula) interval above 430 ms
A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
The use of concomitant medications that prolong the QT/QTc interval
Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Calcitonin above 50 ng/L
History of pancreatitis (acute or chronic)