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Completed

NCT Number: NCT05254158

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

The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body.

The study compares three different doses of the study medicine in Chinese healthy men.

Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance.

NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.

We are testing the study medicine to make a medicine that can help people lose weight.

Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area.

The study will last for about 5 months. But participants participation will last about 2 months.

Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay.

At all visits, except the information visit, participant will have blood drawn along with other clinical examinations.

Participants will be asked about their health, medical history and habits including mental health.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

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

Key inclusion criteria

  • Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening.
  • Body weight between 60.0 and 110.0 kg (both inclusive) at screening.

Key exclusion criteria

  • Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
  • 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 either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)

Primary outcomes

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

    Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)

    measured in h·nmol/L

Secondary outcomes

  1. AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose

    Time frame: From pre-dose (Day 1) to Visit 3 (Day 8)

    measured in h·nmol/L

  2. Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma

    Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)

    measured in nmol/L

  3. tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833

    Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)

    measured in hours

  4. t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833

    Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)

    measured in hours

  5. CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833

    Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)

    measured in L/h

  6. Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase

    Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)

    measured in L

  7. Change in body weight

    Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)

    measured in percentage

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Nov 7, 2023

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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