Clinical trial NCT03015207: First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
Official title: A Randomised, Double-blinded, Single-dose, Dose-escalation, First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or 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: 2017-01-09
Enrollment: 56
Sex: MALE
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.


Eligibility criteria: Inclusion Criteria:

* Male, aged 22-55 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). Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

* Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
* Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) guideline) risk above or equal to 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 (visit 1) until 3 months following administration of the investigational medical product
* Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid

Primary outcomes:
measure: Number of treatment-emergent adverse events (TEAEs)
timeFrame: From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)
Secondary outcomes:
measure: The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration
timeFrame: From pre-dose (day 1) until the followup (day 36)
measure: The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
timeFrame: From pre-dose (day 1) until the followup (day 36)
measure: The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
timeFrame: From pre-dose (day 1) until the followup (day 36)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References: