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
NCT ID: NCT02235961
Last Updated: 2017-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
163 participants
INTERVENTIONAL
2014-09-04
2016-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1
NNC9204-0530
Administered as single subcutaneous (s.c., under the skin) injections.
placebo
Administered as single subcutaneous (s.c., under the skin) injections.
Part 2
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m\^2
Exclusion Criteria
* 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)
18 Years
55 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Overland Park, Kansas, United States
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1151-0761
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9030-4111
Identifier Type: -
Identifier Source: org_study_id
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