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

Obesity Clinical Trial

Official title:

A First Human Dose Trial Investigating 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235961
• Other study ID #: NN9030-4111
• Secondary ID: U1111-1151-0761
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2014
• Last updated: July 25, 2017
• Start date: September 4, 2014
• Est. completion date: July 6, 2016

Study information

• Verified date: July 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 doses of NNC9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 6, 2016
• Est. primary completion date: July 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• NNC9204-0530
Administered as single subcutaneous (s.c., under the skin) injections.
• liraglutide
Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.
• placebo
Administered as single subcutaneous (s.c., under the skin) injections.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events recorded		From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)
Secondary	Area under the NNC9204-0530 serum concentration-time curve		From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Secondary	Maximum concentration of NNC9204-0530 in serum		From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Secondary	The time to maximum concentration of NNC9204-0530 in serum		From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Secondary	The terminal half-life of NNC9204-0530		From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

External Links

•   Clinical Trials at Novo Nordisk