A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.

Obesity Clinical Trial

Official title:

This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941042
• Other study ID #: NN9277-4258
• Secondary ID: U1111-1173-8190
• Status: Completed
• Phase: Phase 1
• Start date: October 10, 2016
• Est. completion date: September 30, 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

Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male, 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

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 above or equal to 5%

• Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• NNC9204-1177
A single dose administered subcutaneously ( s.c. under the skin)
• Placebo
A single dose 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)		From time of dosing (day 1) until completion of the follow-up visit (day 39)
Secondary	Area under the NNC9204-1177 serum concentration-time curve		From 0 to 168 hours after a single s.c. dose
Secondary	Maximum serum concentration of NNC9204-1177	Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39	From time of dosing (day 1) until completion of the follow-up visit (day 39)
Secondary	Time to maximum serum concentration of NNC9204-1177	Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39	From time of dosing (day 1) until completion of the follow-up visit (day 39)
Secondary	Change in body weight		Day 1, day 39
Secondary	Change in QT interval corrected using the Fridericia formula (QTcF)		Day 1, day 39