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

Phase 1

Completed

• Conditions: Obesity; Overweight
• Interventions: Drug: NNC0174-0833; Drug: Placebo (NNC0174-0833)

• Registration Number: NCT03787225
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-26
• Study Start: 2019-01-07
• Status Verified: 2019-06
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0174-0833 (0.3 mg)	NNC0174-0833	Participants will receive single dose of NNC0174-0833
Placebo (NNC0174-0833)	Placebo (NNC0174-0833)	Participants will receive placebo (NNC0174-0833)
NNC0174-0833 (0.9 mg)	NNC0174-0833	Participants will receive single dose of NNC0174-0833
NNC0174-0833 (1.8 mg)	NNC0174-0833	Participants will receive single dose of NNC0174-0833

Primary Outcome Measures

Name	Time	Method
AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)	Measured in h\*nmol/L

Secondary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)	Count of events
Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)	Measured in nmol/L

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Glendale, California, United States