Non-alcoholic Steatohepatitis (NASH)Phase 1NCT05727644
A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
A Phase 1 study testing NNC0194-0499 in people with Non-alcoholic Steatohepatitis (NASH), run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- NNC0194-0499
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2023to 10 Nov 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 18.5-39.9 kilogram per meter square (kg/m2) (both inclusive).
- Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to Kidney Disease: Improving Global Outcomes (KDIGO) 20121, 2 standardized to the individual body surface area (BSA).
- Group description eGFR (mL/min)
- Normal renal function greater than or equal to 90
- Mild renal impairment 60 - 89
Show all 10Show fewer
- Moderate renal impairment 30 - 59
- Severe renal impairment 15 - 29 not requiring dialysis
- End-Stage Renal Disease (ESRD) less than 15 or requiring dialysis treatment Renal group 5 (ESRD).
- Participants requiring dialysis treatment should be on treatment with haemodialysis.
Who cannot join
- Any disorder, except for conditions associated with renal impairment, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. Use of the following are allowed: Routine vitamins, occasional use of paracetamol, ibuprofen and topical medication not reaching systemic circulation.
- Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Renal Impairment and Normal Renal Function
Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- NNC0194-0499
- 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 subcutaneous injection of 30 mg NNC0194-0499.
| Study group | Role | What they receive |
|---|---|---|
| Participants with normal renal function | Active comparator | Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. Receives: Drug: NNC0194-0499 |
| Participants with impaired renal function | Experimental | Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. Receives: Drug: NNC0194-0499 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose
Measured as hours*nanomoles per litre (h*nmol/L)
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Secondary outcomes (6)
Cmax,0499,SD: Maximum observed serum NNC0194-0499 concentration after a single dose
Measured as nanomoles per litre (nmol/L)
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
tmax,0499,SD: Time to maximum observed serum NNC0194-0499 concentration after a single dose
Measured in hours (h)
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
t½,0499,SD: Terminal half-life of NNC0194-0499 after a single dose
Measured in hours (h)
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Vz/F0499,SD: Apparent volume of distribution of NNC0194-0499 after a single dose
Measured as Litre (L)
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
CL/F0499,SD: Apparent clearance of NNC0194-0499 after a single dose
Measured as Litre per hour (L/h)
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
CLR,0499,SD: Renal clearance of NNC0194-0499 after a single dose
Measured as Litre per hour (L/h)
Measured: From baseline (Visit 2, Day 1, predose) until completion of the urine collection period 96 hours after dosing (Visit 2, Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start15 Feb 2023
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (NASH)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT05727644
- Sponsor's protocol ID
- NN9500-4620
- Other IDs
- U1111-1277-3646, 2022-001849-20
- Status last verified
- Dec 2023
- First submitted
- 5 Feb 2023
- Last updated
- 6 Dec 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Renal Impairment and Normal Renal Function
- ClinicalTrials.gov ID
- NCT05727644
- Acronym / sponsor ID
- NN9500-4620
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 14 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.
Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with normal renal function | Active comparator | Drug: NNC0194-0499Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. |
| Participants with impaired renal function | Experimental | Drug: NNC0194-0499Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 18.5-39.9 kilogram per meter square (kg/m2) (both inclusive).
- Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to Kidney Disease: Improving Global Outcomes (KDIGO) 20121, 2 standardized to the individual body surface area (BSA).
- Group description eGFR (mL/min)
- Normal renal function greater than or equal to 90
Key exclusion criteria (4 listed)
- Any disorder, except for conditions associated with renal impairment, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. Use of the following are allowed: Routine vitamins, occasional use of paracetamol, ibuprofen and topical medication not reaching systemic circulation.
- Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
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 subcutaneous injection of 30 mg NNC0194-0499. | Drug | Participants with impaired renal function, Participants with normal renal function |
Primary outcome
AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Measured as hours*nanomoles per litre (h*nmol/L)
6 secondary outcomes
Cmax,0499,SD: Maximum observed serum NNC0194-0499 concentration after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
tmax,0499,SD: Time to maximum observed serum NNC0194-0499 concentration after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
t½,0499,SD: Terminal half-life of NNC0194-0499 after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Vz/F0499,SD: Apparent volume of distribution of NNC0194-0499 after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
CL/F0499,SD: Apparent clearance of NNC0194-0499 after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
CLR,0499,SD: Renal clearance of NNC0194-0499 after a single dose
Time frame: From baseline (Visit 2, Day 1, predose) until completion of the urine collection period 96 hours after dosing (Visit 2, Day 5)
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 6 Dec 2023.
- 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 in people with Non-alcoholic Steatohepatitis (NASH), run by Novo Nordisk A/S at 1 site in Germany.
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 10 inclusion and 4 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 6 Dec 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 Germany. 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?
AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose (time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, 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 6 Dec 2023.