A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

Obesity Clinical Trial

Official title:

Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787225
• Other study ID #: NN9838-4483
• Secondary ID: U1111-1219-7303
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2019
• Est. completion date: June 4, 2019

Study information

• Verified date: June 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male, aged 18-55 years (both inclusive) at the time of signing informed consent.

• For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.

• For Caucasian subjects, self-reported European descent or white Latin-American descent.

• Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

• Body weight between 60 and 110 kg (both inclusive) at screening

Exclusion Criteria:

• Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner[s] of childbearing potential), who is 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 less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.

• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• NNC0174-0833
Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
• Placebo (NNC0174-0833)
Participants will receive NNC0174-0833 matched placebo subcutaneously.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Glendale	California

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	AUC0-8,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose	Measured in h*nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma	Measured in nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Number of treatment emergent adverse events (TEAEs)	Count of events	From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)