Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Metabolism and Nutrition Disorder
Obesity
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2016
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT02235961
Start Date
September 4 2014
End Date
July 6 2016
Last Update
July 27 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Overland Park, Kansas, United States, 66212