Clinical trial NCT05254158: A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
Official title: Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight and Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary outcomes:
measure: AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose
timeFrame: From pre-dose (Day 1) to Visit 3 (Day 8)
measure: Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma
timeFrame: From pre-dose (Day 1) to Visit 7 (Day 36)
measure: tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833
timeFrame: From pre-dose (Day 1) to Visit 7 (Day 36)
measure: t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833
timeFrame: From pre-dose (Day 1) to Visit 7 (Day 36)
measure: CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833
timeFrame: From pre-dose (Day 1) to Visit 7 (Day 36)
measure: Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase
timeFrame: From pre-dose (Day 1) to Visit 7 (Day 36)
measure: Change in body weight
timeFrame: From pre-dose (Day 1) to Visit 7 (Day 36)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: