Overweight and ObesityPhase 1NCT05254158
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
A Phase 1 study testing NNC0174 0833 in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- NNC0174 0833
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2022to 7 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being 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.
Read more
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.
- Conditions
- Overweight and Obesity
- Being tested
- NNC0174 0833
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0174 0833Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| NNC0174 0833 1.8 mg | Experimental | Each participant will receive one single dose of NNC0174 0833 Receives: Drug: NNC0174 0833 |
| NNC0174 0833 0.9 mg | Experimental | Each participant will receive one single dose of NNC0174 0833 Receives: Drug: NNC0174 0833 |
| NNC0174 0833 0.3 mg | Experimental | Each participant will receive one single dose of NNC0174 0833 Receives: Drug: NNC0174 0833 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose
measured in h·nmol/L
Measured: From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary outcomes (7)
AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose
measured in h·nmol/L
Measured: From pre-dose (Day 1) to Visit 3 (Day 8)
Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma
measured in nmol/L
Measured: From pre-dose (Day 1) to Visit 7 (Day 36)
tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833
measured in hours
Measured: From pre-dose (Day 1) to Visit 7 (Day 36)
t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833
measured in hours
Measured: From pre-dose (Day 1) to Visit 7 (Day 36)
CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833
measured in L/h
Measured: From pre-dose (Day 1) to Visit 7 (Day 36)
Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase
measured in L
Measured: From pre-dose (Day 1) to Visit 7 (Day 36)
Change in body weight
measured in percentage
Measured: From pre-dose (Day 1) to Visit 7 (Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start3 Mar 2022
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254158
- Sponsor's protocol ID
- NN9838-4615
- Other IDs
- U1111-1247-7538
- Status last verified
- Nov 2023
- First submitted
- 15 Feb 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity
- ClinicalTrials.gov ID
- NCT05254158
- Acronym / sponsor ID
- NN9838-4615
- Conditions
- Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NNC0174 0833 1.8 mg | Experimental | Drug: NNC0174 0833Each participant will receive one single dose of NNC0174 0833 |
| NNC0174 0833 0.9 mg | Experimental | Drug: NNC0174 0833Each participant will receive one single dose of NNC0174 0833 |
| NNC0174 0833 0.3 mg | Experimental | Drug: NNC0174 0833Each participant will receive one single dose of NNC0174 0833 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0174 0833Participants 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) | Drug | NNC0174 0833 0.3 mg, NNC0174 0833 0.9 mg, NNC0174 0833 1.8 mg |
Primary outcome
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
7 secondary outcomes
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)
Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma
Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)
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)
t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833
Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)
CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833
Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)
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)
Change in body weight
Time frame: From pre-dose (Day 1) to Visit 7 (Day 36)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0174 0833 in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.