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

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: NNC9204-0530; Drug: placebo; Drug: liraglutide

• Registration Number: NCT02235961
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-02
• Study Start: 2014-09-04
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-10
• Primary Completion: 2016-07-06
• Study Completion: 2016-07-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 163

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1	NNC9204-0530	-
Part 1	placebo	-
Part 2	NNC9204-0530	-
Part 2	placebo	-
Part 2	liraglutide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Overland Park, Kansas, United States