Back to resultsInvestigate 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
Primary Purpose
Metabolism and Nutrition Disorder, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC9204-0530
liraglutide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorder
Eligibility Criteria
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)
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1
Part 2
Arm Description
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events recorded
Secondary Outcome Measures
Area under the NNC9204-0530 serum concentration-time curve
Maximum concentration of NNC9204-0530 in serum
The time to maximum concentration of NNC9204-0530 in serum
The terminal half-life of NNC9204-0530
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02235961
Brief Title
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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 4, 2014 (Actual)
Primary Completion Date
July 6, 2016 (Actual)
Study Completion Date
July 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1
Arm Type
Experimental
Arm Title
Part 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC9204-0530
Intervention Description
Administered as single subcutaneous (s.c., under the skin) injections.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered as single subcutaneous (s.c., under the skin) injections.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events recorded
Time Frame
From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)
Secondary Outcome Measure Information:
Title
Area under the NNC9204-0530 serum concentration-time curve
Time Frame
From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Title
Maximum concentration of NNC9204-0530 in serum
Time Frame
From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Title
The time to maximum concentration of NNC9204-0530 in serum
Time Frame
From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Title
The terminal half-life of NNC9204-0530
Time Frame
From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
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
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