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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03095807
Other study ID # NN9423-4302
Secondary ID U1111-1177-7821
Status Completed
Phase Phase 1
First received
Last updated
Start date March 20, 2017
Est. completion date August 31, 2017

Study information

Verified date October 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NNC9204-1706 A
Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.
Placebo
Administered subcutaneously (s.c., under the skin)

Locations

Country Name City State
United States Novo Nordisk Investigational Site Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment-emergent adverse events (TEAEs) Count and % of events From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)
Secondary Area under the NNC9204-1706 plasma concentration-time curve Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary Area under the NNC9204-1706 plasma concentration-time curve (0-24h) Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample) Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary Maximal observed concentration of the NNC9204-1706 plasma concentration curve Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary Time to observed maximum concentration of NNC9204-1706 in plasma Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary Terminal half-life of NNC9204-1706 Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary Mean residence time of NNC9204-1706 Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary The apparent total plasma clearance of NNC9204-1706 Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary The apparent volume of distribution of NNC9204-1706 Calculated based on NNC9204-1706 measured in blood. Day 1- Day 7
Secondary Changes in Body weight Measured in kg and/or % Day 1, Days 10-13
Secondary Number of injection-site reactions Count of reactions From the time of dosing (Day 1) to the follow-up visit (Days 10-13)
Secondary Number of hypoglycaemic episodes Count of episodes from time of dosing (Day 1) to the follow-up visit (Days 10-13)
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