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First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

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ClinicalTrials.gov Identifier: NCT03015207
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC0194-0499 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blinded, Single-dose, Dose-escalation, First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

Arm Intervention/treatment
Experimental: NNC0194-0499
Injected s.c. /subcutaneously (under the skin)
Drug: NNC0194-0499
Placebo Comparator: Placebo
Injected s.c. /subcutaneously (under the skin)
Drug: Placebo



Primary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36) ]

Secondary Outcome Measures :
  1. The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration [ Time Frame: From pre-dose (day 1) until the followup (day 36) ]
  2. The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration [ Time Frame: From pre-dose (day 1) until the followup (day 36) ]
  3. The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration [ Time Frame: From pre-dose (day 1) until the followup (day 36) ]


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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, aged 22-55 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

  • Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
  • Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) guideline) risk above or equal to 5%
  • Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening (visit 1) until 3 months following administration of the investigational medical product
  • Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid

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): NCT03015207


Locations
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United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03015207    
Other Study ID Numbers: NN9499-4277
U1111-1181-9045 ( Other Identifier: WHO )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Obesity
Nutrition Disorders
Overweight
Overnutrition
Body Weight