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A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03787225
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE December 21, 2018
First Posted Date  ICMJE December 26, 2018
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE January 7, 2019
Actual Primary Completion Date June 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose [ Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) ]
Measured in h*nmol/L
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma [ Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) ]
    Measured in nmol/L
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36) ]
    Count of events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
Official Title  ICMJE Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With Obesity
Brief Summary The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Drug: NNC0174-0833
    Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
  • Drug: Placebo (NNC0174-0833)
    Participants will receive NNC0174-0833 matched placebo subcutaneously.
Study Arms  ICMJE
  • Experimental: NNC0174-0833 (0.3 mg)
    Participants will receive single dose of NNC0174-0833
    Intervention: Drug: NNC0174-0833
  • Experimental: NNC0174-0833 (0.9 mg)
    Participants will receive single dose of NNC0174-0833
    Intervention: Drug: NNC0174-0833
  • Experimental: NNC0174-0833 (1.8 mg)
    Participants will receive single dose of NNC0174-0833
    Intervention: Drug: NNC0174-0833
  • Placebo Comparator: Placebo (NNC0174-0833)
    Participants will receive placebo (NNC0174-0833)
    Intervention: Drug: Placebo (NNC0174-0833)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2019)
66
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
72
Actual Study Completion Date  ICMJE June 4, 2019
Actual Primary Completion Date June 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
  • For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
  • For Caucasian subjects, self-reported European descent or white Latin-American descent.
  • Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Body weight between 60 and 110 kg (both inclusive) at screening

Exclusion Criteria:

  • Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner[s] of childbearing potential), who is 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 less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787225
Other Study ID Numbers  ICMJE NN9838-4483
U1111-1219-7303 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure 1452 Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP