Non-alcoholic Fatty Liver DiseasePhase 1NCT05742919
A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
A Phase 1 study testing NNC0194-0499 and NC0194-0499 in people with Non-alcoholic Fatty Liver Disease, run by Novo Nordisk A/S at 1 site in China.
Trial summary
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- NNC0194-0499 and NC0194-0499
- 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
- 16 Feb 2023to 13 Jun 2023
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive).
- Body weight greater than or equal to 60 kg.
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study intervention or related products.
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- NNC0194-0499, NC0194-0499
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0194-0499Drug
Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.
NNC0194-0499Drug
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
NC0194-0499Drug
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| NNC0194-0499 12 mg | Experimental | Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1. Receives: Drug: NNC0194-0499 |
| NNC0194-0499 30 mg | Experimental | Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1. Receives: Drug: NNC0194-0499 |
| NNC0194-0499 96 mg | Experimental | Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. Receives: Drug: NC0194-0499 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
Measured in nanomoles*hours per liter (nmol h/L).
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary outcomes (9)
AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose
Measured in nmol h/L.
Measured: From Day 1 (pre-dose) until Day 7 (168 hours)
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum
Measured in nmol/L.
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499
Measured in hours.
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499
Measured in hours.
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499
Measured in liters per hour (L/h).
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase
Measured in liters (L).
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in triglycerides
Measured in Percent change.
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in high-density lipoprotein (HDL) cholesterol
Measured in Percent change.
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in low-density lipoprotein (LDL) cholesterol
Measured in Percent change.
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (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 2023
- Study start16 Feb 2023
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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
- None (open label)
- 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. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742919
- Sponsor's protocol ID
- NN9500-4796
- Other IDs
- U1111-1267-4230
- Status last verified
- Jun 2024
- First submitted
- 14 Feb 2023
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males
- ClinicalTrials.gov ID
- NCT05742919
- Acronym / sponsor ID
- NN9500-4796
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 24 Feb 2023 (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.
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NNC0194-0499 12 mg | Experimental | Drug: NNC0194-0499Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1. |
| NNC0194-0499 30 mg | Experimental | Drug: NNC0194-0499Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1. |
| NNC0194-0499 96 mg | Experimental | Drug: NC0194-0499Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive).
- Body weight greater than or equal to 60 kg.
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to study intervention or related products.
- Any disorder, which in the investigator's opinion might jeopardise participant'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 |
|---|---|---|
| NNC0194-0499Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1. | Drug | NNC0194-0499 12 mg |
| NNC0194-0499Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1. | Drug | NNC0194-0499 30 mg |
| NC0194-0499Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. | Drug | NNC0194-0499 96 mg |
Primary outcome
AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in nanomoles*hours per liter (nmol h/L).
9 secondary outcomes
AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose
Time frame: From Day 1 (pre-dose) until Day 7 (168 hours)
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in triglycerides
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in high-density lipoprotein (HDL) cholesterol
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in low-density lipoprotein (LDL) cholesterol
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (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 11 Jun 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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. 2834 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 NNC0194-0499 and NC0194-0499 in people with Non-alcoholic Fatty Liver Disease, 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 5 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 11 Jun 2024. 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-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose (time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (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 11 Jun 2024.