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Completed

NCT Number: NCT03787225

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0174-0833

Drug

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)

Drug

Participants will receive NNC0174-0833 matched placebo subcutaneously.

Primary outcomes

  1. AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in h*nmol/L

Secondary outcomes

  1. Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in nmol/L

  2. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)

    Count of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2018
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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