Back to resultsA Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC0174-0833
Placebo (NNC0174-0833)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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.
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
NNC0174-0833 (0.3 mg)
NNC0174-0833 (0.9 mg)
NNC0174-0833 (1.8 mg)
Placebo (NNC0174-0833)
Arm Description
Participants will receive single dose of NNC0174-0833
Participants will receive single dose of NNC0174-0833
Participants will receive single dose of NNC0174-0833
Participants will receive placebo (NNC0174-0833)
Outcomes
Primary Outcome Measures
AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose
Measured in h*nmol/L
Secondary Outcome Measures
Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma
Measured in nmol/L
Number of treatment emergent adverse events (TEAEs)
Count of events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03787225
Brief Title
A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC0174-0833 (0.3 mg)
Arm Type
Experimental
Arm Description
Participants will receive single dose of NNC0174-0833
Arm Title
NNC0174-0833 (0.9 mg)
Arm Type
Experimental
Arm Description
Participants will receive single dose of NNC0174-0833
Arm Title
NNC0174-0833 (1.8 mg)
Arm Type
Experimental
Arm Description
Participants will receive single dose of NNC0174-0833
Arm Title
Placebo (NNC0174-0833)
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (NNC0174-0833)
Intervention Type
Drug
Intervention Name(s)
NNC0174-0833
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (NNC0174-0833)
Intervention Description
Participants will receive NNC0174-0833 matched placebo subcutaneously.
Primary Outcome Measure Information:
Title
AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose
Description
Measured in h*nmol/L
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary Outcome Measure Information:
Title
Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma
Description
Measured in nmol/L
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
Number of treatment emergent adverse events (TEAEs)
Description
Count of events
Time Frame
From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure 1452
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
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