Back to resultsInvestigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
Primary Purpose
Metabolism and Nutrition Disorder, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC9204-1706 A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorder
Eligibility Criteria
Inclusion Criteria:
- Male subjects aged 18-55 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) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator
Exclusion Criteria:
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
- Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk equal to or above 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 until 3 months following administration of the investigational medical product
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NNC9204-1706 A
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of treatment-emergent adverse events (TEAEs)
Count and % of events
Secondary Outcome Measures
Area under the NNC9204-1706 plasma concentration-time curve
Calculated based on NNC9204-1706 measured in blood.
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)
Calculated based on NNC9204-1706 measured in blood.
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)
Calculated based on NNC9204-1706 measured in blood.
Maximal observed concentration of the NNC9204-1706 plasma concentration curve
Calculated based on NNC9204-1706 measured in blood.
Time to observed maximum concentration of NNC9204-1706 in plasma
Calculated based on NNC9204-1706 measured in blood.
Terminal half-life of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
Mean residence time of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
The apparent total plasma clearance of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
The apparent volume of distribution of NNC9204-1706
Calculated based on NNC9204-1706 measured in blood.
Changes in Body weight
Measured in kg and/or %
Number of injection-site reactions
Count of reactions
Number of hypoglycaemic episodes
Count of episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03095807
Brief Title
Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
Official Title
Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (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
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC9204-1706 A
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NNC9204-1706 A
Intervention Description
Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered subcutaneously (s.c., under the skin)
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events (TEAEs)
Description
Count and % of events
Time Frame
From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)
Secondary Outcome Measure Information:
Title
Area under the NNC9204-1706 plasma concentration-time curve
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
Maximal observed concentration of the NNC9204-1706 plasma concentration curve
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
Time to observed maximum concentration of NNC9204-1706 in plasma
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
Terminal half-life of NNC9204-1706
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
Mean residence time of NNC9204-1706
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
The apparent total plasma clearance of NNC9204-1706
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
The apparent volume of distribution of NNC9204-1706
Description
Calculated based on NNC9204-1706 measured in blood.
Time Frame
Day 1- Day 7
Title
Changes in Body weight
Description
Measured in kg and/or %
Time Frame
Day 1, Days 10-13
Title
Number of injection-site reactions
Description
Count of reactions
Time Frame
From the time of dosing (Day 1) to the follow-up visit (Days 10-13)
Title
Number of hypoglycaemic episodes
Description
Count of episodes
Time Frame
from time of dosing (Day 1) to the follow-up visit (Days 10-13)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male subjects aged 18-55 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) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator
Exclusion Criteria:
Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk equal to or above 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 until 3 months following administration of the investigational medical product
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Learn more about this trial
Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
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