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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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ClinicalTrials.gov Identifier: NCT02235961
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC9204-0530 Drug: liraglutide Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 4, 2014
Actual Primary Completion Date : July 6, 2016
Actual Study Completion Date : July 6, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Part 1 Drug: NNC9204-0530
Administered as single subcutaneous (s.c., under the skin) injections.

Drug: placebo
Administered as single subcutaneous (s.c., under the skin) injections.

Experimental: Part 2 Drug: NNC9204-0530
Administered as single subcutaneous (s.c., under the skin) injections.

Drug: liraglutide
Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.

Drug: placebo
Administered as single subcutaneous (s.c., under the skin) injections.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235961


Locations
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United States, Kansas
Novo Nordisk Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02235961    
Other Study ID Numbers: NN9030-4111
U1111-1151-0761 ( Registry Identifier: WHO )
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Nutrition Disorders
Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists