Clinical trial NCT03095807: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-03-30
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of treatment-emergent adverse events (TEAEs)
timeFrame: From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)
Secondary outcomes:
measure: Area under the NNC9204-1706 plasma concentration-time curve
timeFrame: Day 1- Day 7
measure: Area under the NNC9204-1706 plasma concentration-time curve (0-24h)
timeFrame: Day 1- Day 7
measure: Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)
timeFrame: Day 1- Day 7
measure: Maximal observed concentration of the NNC9204-1706 plasma concentration curve
timeFrame: Day 1- Day 7
measure: Time to observed maximum concentration of NNC9204-1706 in plasma
timeFrame: Day 1- Day 7
measure: Terminal half-life of NNC9204-1706
timeFrame: Day 1- Day 7
measure: Mean residence time of NNC9204-1706
timeFrame: Day 1- Day 7
measure: The apparent total plasma clearance of NNC9204-1706
timeFrame: Day 1- Day 7
measure: The apparent volume of distribution of NNC9204-1706
timeFrame: Day 1- Day 7
measure: Changes in Body weight
timeFrame: Day 1, Days 10-13
measure: Number of injection-site reactions
timeFrame: From the time of dosing (Day 1) to the follow-up visit (Days 10-13)
measure: Number of hypoglycaemic episodes
timeFrame: from time of dosing (Day 1) to the follow-up visit (Days 10-13)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
Study officials:
References: