Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

Obesity Clinical Trial

Official title:

Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

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
• 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
• 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

Related Conditions & MeSH terms

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

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)