Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 25, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: NNC0174-0833 Drug: Placebo (NNC0174-0833) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
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
Official Title: 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
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 4, 2019

Arm Intervention/treatment
Experimental: NNC0174-0833 (0.3 mg)
Participants will receive single dose of NNC0174-0833
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.

Experimental: NNC0174-0833 (0.9 mg)
Participants will receive single dose of NNC0174-0833
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.

Experimental: NNC0174-0833 (1.8 mg)
Participants will receive single dose of NNC0174-0833
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.

Placebo Comparator: Placebo (NNC0174-0833)
Participants will receive placebo (NNC0174-0833)
Drug: Placebo (NNC0174-0833)
Participants will receive NNC0174-0833 matched placebo subcutaneously.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03787225


Locations
Layout table for location information
United States, California
Novo Nordisk Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Clinical Reporting Anchor and Disclosure 1452 Novo Nordisk A/S

Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03787225     History of Changes
Other Study ID Numbers: NN9838-4483
U1111-1219-7303 ( Other Identifier: World Health Organization (WHO) )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
URL: http://novonordisk-trials.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms