A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
NNC0174 0833
Sponsored by

About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
Key inclusion criteria
- Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening.
- Body weight between 60.0 and 110.0 kg (both inclusive) at screening.
Key exclusion criteria
- Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
- 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 Type
Experimental
Experimental
Experimental
Arm Label
NNC0174 0833 1.8 mg
NNC0174 0833 0.9 mg
NNC0174 0833 0.3 mg
Arm Description
Each participant will receive one single dose of NNC0174 0833
Each participant will receive one single dose of NNC0174 0833
Each participant will receive one single dose of NNC0174 0833
Outcomes
Primary Outcome Measures
AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose
measured in h·nmol/L
Secondary Outcome Measures
AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose
measured in h·nmol/L
Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma
measured in nmol/L
tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833
measured in hours
t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833
measured in hours
CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833
measured in L/h
Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase
measured in L
Change in body weight
measured in percentage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05254158
Brief Title
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
Official Title
Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
September 7, 2022 (Actual)
Study Completion Date
September 7, 2022 (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
No
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 participants body and how it is removed from their body.
The study compares three different doses of the study medicine in Chinese healthy men.
Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance.
NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.
We are testing the study medicine to make a medicine that can help people lose weight.
Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area.
The study will last for about 5 months. But participants participation will last about 2 months.
Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay.
At all visits, except the information visit, participant will have blood drawn along with other clinical examinations.
Participants will be asked about their health, medical history and habits including mental health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC0174 0833 1.8 mg
Arm Type
Experimental
Arm Description
Each participant will receive one single dose of NNC0174 0833
Arm Title
NNC0174 0833 0.9 mg
Arm Type
Experimental
Arm Description
Each participant will receive one single dose of NNC0174 0833
Arm Title
NNC0174 0833 0.3 mg
Arm Type
Experimental
Arm Description
Each participant will receive one single dose of NNC0174 0833
Intervention Type
Drug
Intervention Name(s)
NNC0174 0833
Intervention Description
Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)
Primary Outcome Measure Information:
Title
AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose
Description
measured in h·nmol/L
Time Frame
From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary Outcome Measure Information:
Title
AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose
Description
measured in h·nmol/L
Time Frame
From pre-dose (Day 1) to Visit 3 (Day 8)
Title
Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma
Description
measured in nmol/L
Time Frame
From pre-dose (Day 1) to Visit 7 (Day 36)
Title
tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833
Description
measured in hours
Time Frame
From pre-dose (Day 1) to Visit 7 (Day 36)
Title
t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833
Description
measured in hours
Time Frame
From pre-dose (Day 1) to Visit 7 (Day 36)
Title
CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833
Description
measured in L/h
Time Frame
From pre-dose (Day 1) to Visit 7 (Day 36)
Title
Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase
Description
measured in L
Time Frame
From pre-dose (Day 1) to Visit 7 (Day 36)
Title
Change in body weight
Description
measured in percentage
Time Frame
From pre-dose (Day 1) to Visit 7 (Day 36)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key inclusion criteria
Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening.
Body weight between 60.0 and 110.0 kg (both inclusive) at screening.
Key exclusion criteria
Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
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 Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
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