First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015207
• Other study ID #: NN9499-4277
• Secondary ID: U1111-1181-9045
• Status: Completed
• Phase: Phase 1
• Start date: January 6, 2017
• Est. completion date: October 26, 2017

Study information

• Verified date: September 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• NNC0194-0499

• Placebo

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	San Antonio	Texas

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)		From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)
Secondary	The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration		From pre-dose (day 1) until the followup (day 36)
Secondary	The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration		From pre-dose (day 1) until the followup (day 36)
Secondary	The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration		From pre-dose (day 1) until the followup (day 36)