Liver DiseasesPhase 1NCT06336018
A Research Study on Etavopivat in Participants With and Without Liver Disease
A Phase 1 study testing Etavopivat in people with Liver Diseases, run by Novo Nordisk A/S at 5 sites in United States.
Trial summary
The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Etavopivat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 May 2024to 1 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 42.0 kilogram per meter^2 (kg/m^2) (both inclusive) at screening.
- Body weight greater than or equal to (>=) 40.0 kilogram (kg) at screening.
- Specific inclusion criteria only for participants with hepatic impairment:
- Participants with chronic (above 6 months), stable (no significant deterioration in hepatic function in last 2 months as determined by the investigator) hepatic impairment classified as Child-Pugh class A, B or C, as assessed by the investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound, computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy.
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- Participants must be on a stable dose of medication and/or treatment regimen (e.g., no expectations of new medications nor changes to current medications within 14 days of dosing).
- Specific inclusion criterion only for participants with normal hepatic function:
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and laboratory safety tests performed during screening visit, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study intervention or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
- Participation (i.e., signed informed consent) in any interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer, before screening.
- Any disorder, unwillingness or inability, except for conditions associated with hepatic impairment in the group of participants with compromised hepatic function, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Participant is unable to refrain from or anticipates the use of, for 7 days prior to dosing and throughout the study, any drug known to be:
- an inhibitor of uridine 5'-diphospho-glucuronosyltransferase (UGT) 2B7,
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- a strong inhibitor of cytochrome P450 (CYP)3A4 or CYP2C9,
- a potent inhibitor of permeability glycoprotein (P-gp).
- Participant is unable to refrain from or anticipates the use of, for 28 days prior to dosing and throughout the study, any drug known to be:
- an inducer of UGT2B7,
- a strong or moderate inducer of CYP3A4, including St. John's Wort,
- a strong inducer of CYP2C9,
- a potent inducer of P-gp.
- Participant is unable to refrain from or anticipates the use of any medications or substances prohibited in the study.
- Specific exclusion criterion only for participants with hepatic impairment:
- Clinical signs of an acute hepatitis (viral as well as non-viral) or positive tests of hepatitis B virus surface antigen (HBsAg) (unless hepatitis B virus titre is negative) or antibody tests of hepatitis C virus (HCV-Ab) (unless negative polymerase chain reaction [PCR] for hepatitis C virus).
- Specific exclusion criteria only for participants with normal hepatic function:
- Diagnostic test results positive for hepatitis B or hepatitis C infection.
- History of diabetes mellitus or glycated haemoglobin (HbA1c) greater than or equal to 5 percent (48 millimoles per mole [mmol/mol]) at screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cure Clinical Research LLC
Orange, California, 92866
Orlando Clinical Research Center
Orlando, Florida, 32806
Orlando Clinical Research Center
Orlando, Florida, 32809
Amer. Rrsch Corp-TX Liver Inst
San Antonio, Texas, 78215
Pinnacle Clinical Research
San Antonio, Texas, 78229
About this study
Official title: A Multi-centre, Open-label, Parallel-group Study Investigating the Pharmacokinetics, Safety and Tolerability After a Single Dose of Oral Etavopivat in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function
The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days.
- Conditions
- Liver Diseases
- Being tested
- Etavopivat
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtavopivatDrug
Participants will receive a single dose of etavopivat orally.
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment: Etavopivat dose 2 | Experimental | Participants will receive a single dose of oral etavopivat. Receives: Drug: Etavopivat |
| Moderate hepatic impairment: Etavopivat dose 2 | Experimental | Participants will receive a single dose of oral etavopivat. Receives: Drug: Etavopivat |
| Healthy matched controls: Etavopivat dose 2 | Experimental | Participants will receive a single dose of oral etavopivat. Receives: Drug: Etavopivat |
| Severe hepatic impairment: Etavopivat dose 1 | Experimental | Participants will receive a single dose of oral etavopivat. Receives: Drug: Etavopivat |
| Healthy matched controls: Etavopivat dose 1 | Experimental | Participants will receive a single dose of oral etavopivat. Receives: Drug: Etavopivat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat)
Measured in hours*nanogram per milliter (h*ng/mL).
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat)
Measured in nanogram per milliter (ng/mL).
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Secondary outcomes (6)
Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat)
Measured in h*ng/mL.
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat)
Measured in hours.
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Terminal half-life for etavopivat after a single dose (t1/2, etavopivat)
Measured in hours.
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat)
Measured in liter per hour (L/h).
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat)
Measured in liter (L).
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Number of adverse events (AEs)
Measured as count of events.
Measured: From IMP administration on day 1 to completion of the end of study visit (day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start20 May 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- 48 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
- NCT06336018
- Sponsor's protocol ID
- NN7535-7703
- Other IDs
- U1111-1289-2466
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open-label, Parallel-group Study Investigating the Pharmacokinetics, Safety and Tolerability After a Single Dose of Oral Etavopivat in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06336018
- Acronym / sponsor ID
- NN7535-7703
- Conditions
- Liver Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 28 Mar 2024 (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 study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment: Etavopivat dose 2 | Experimental | Drug: EtavopivatParticipants will receive a single dose of oral etavopivat. |
| Moderate hepatic impairment: Etavopivat dose 2 | Experimental | Drug: EtavopivatParticipants will receive a single dose of oral etavopivat. |
| Healthy matched controls: Etavopivat dose 2 | Experimental | Drug: EtavopivatParticipants will receive a single dose of oral etavopivat. |
| Severe hepatic impairment: Etavopivat dose 1 | Experimental | Drug: EtavopivatParticipants will receive a single dose of oral etavopivat. |
| Healthy matched controls: Etavopivat dose 1 | Experimental | Drug: EtavopivatParticipants will receive a single dose of oral etavopivat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female.
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 42.0 kilogram per meter^2 (kg/m^2) (both inclusive) at screening.
- Body weight greater than or equal to (>=) 40.0 kilogram (kg) at screening.
- Participants with chronic (above 6 months), stable (no significant deterioration in hepatic function in last 2 months as determined by the investigator) hepatic impairment classified as Child-Pugh class A, B or C, as assessed by the investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound, computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy.
Key exclusion criteria (19 listed)
- Known or suspected hypersensitivity to study intervention or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
- Participation (i.e., signed informed consent) in any interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer, before screening.
- Any disorder, unwillingness or inability, except for conditions associated with hepatic impairment in the group of participants with compromised hepatic function, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Participant is unable to refrain from or anticipates the use of, for 7 days prior to dosing and throughout the study, any drug known to be:
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 |
|---|---|---|
| EtavopivatParticipants will receive a single dose of etavopivat orally. | Drug | Healthy matched controls: Etavopivat dose 1, Healthy matched controls: Etavopivat dose 2, Mild hepatic impairment: Etavopivat dose 2, Moderate hepatic impairment: Etavopivat dose 2, Severe hepatic impairment: Etavopivat dose 1 |
Primary outcome
Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in hours*nanogram per milliter (h*ng/mL).
Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in nanogram per milliter (ng/mL).
6 secondary outcomes
Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Terminal half-life for etavopivat after a single dose (t1/2, etavopivat)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Number of adverse events (AEs)
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
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 18 Jun 2026.
- 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etavopivat in people with Liver Diseases, run by Novo Nordisk A/S at 5 sites in United States.
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 9 inclusion and 19 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat) (time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)). The study lists 2 primary outcomes in all. 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 18 Jun 2026.