NASH - Nonalcoholic SteatohepatitisPhase 2NCT04874233
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
A Phase 2 study testing HU6 in people with NASH - Nonalcoholic Steatohepatitis, run by Rivus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat. Read more about this study
- Who is it for?
- Ages 28 to 65 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- HU6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 15 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 28 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult male or females, 28 to 65 years of age (inclusive) at the time of informed consent with BMI between 28.0 and 45.0 kg/m2 (inclusive).
- Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative urine pregnancy test at Screening and agree to continue using an effective method of contraception for at least 4 weeks or barrier method for 2 weeks prior to first study drug administration until 30 days after the last dose of study drug (Section 8.3.2).
- Female subjects of childbearing potential must not donate ova during the study and for at least 30 days after the last dose of study drug.
- Female subjects of non-childbearing potential must be surgically sterile (e.g., hysterectomy, bilateral tubal ligation, oophorectomy) or postmenopausal (no menses for >1 year with follicle stimulating hormone (FSH) >40 U/L at Screening).
- Male subjects who have not had a vasectomy and/or subjects who have had a vasectomy but have not had 2 post surgery negative tests for sperm must agree to use an acceptable method of contraception from time of first dose of study drug until 30 days after the last dose of the study drug, and to not donate sperm during the study and for at least 30 days after the last dose of study drug.
- 2. Inclusion as per investigator assessment of general medical status and as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations.
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- Subjects must be on stable doses of medications for underlying obesity-related conditions for at least 2 months prior to screening.
- Subjects with diabetes may be treated with metformin, DPP-4 inhibitors, or sulfonylureas, but must be on stable doses for at least 2 months prior to screening.
- At Screening, certain laboratory values may be outside the reference range if commensurate with the underlying obesity or associated metabolic dysfunction in the eligible subject (for example, dyslipidemia and hyperglycemia), unless these abnormalities suggest an underlying condition which may impact subject safety in the trial or interfere with the evaluation of HU6 or affect interpretation of the study results.
- Abnormalities or deviations outside the normal ranges for other assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs, physical examination) may be repeated once at the discretion of the Investigator(s). Results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- Subjects with elevation of unconjugated bilirubin due to presumptive Gilbert's syndrome are permissible.
- Subject must be euthyroid as assessed by a thyroid profile utilizing thyroid stimulating hormone (TSH) and free thyroxine (T4) testing at screening. Subjects with a stable history of thyroid disease and who have been on stable doses of thyroid medications for a minimum of 4 months can be enrolled.
- 3. Fibroscan® CAP score>300 dB/m. 4. ≥8% liver fat by MRI-PDFF. 5. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
- 6. Willing and able to comply with the requirements of the study protocol.
Who cannot join
- Subjects will be excluded from the study if any of the following criteria are met:
- Insulin-controlled diabetes.
- Pregnant or breastfeeding or plans to become pregnant.
- Intolerance to Magnetic Resonance Imaging (MRI) or with conditions contraindicated for MRI procedures including but not limited to inability to fit into MRI scanner or surgical clips/metallic implants/shrapnel. Subjects must not be claustrophobic, have a history of claustrophobia, or intolerance of closed or small spaces.
- Weight gain or loss >5% in 3 months prior to study or >10% in 6 months prior to screening.
- History of lap banding, intragastric balloon, duodenal-jejunal sleeve, or bariatric surgery within 5 years of screening, plans for bariatric surgery prior to conclusion of study participation, or plans to lose weight during this study either through a special diet, exercise program or both.
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- History of malignant hyperthermia.
- History of chronic serious recurrent skin rashes of unknown cause.
- History of or current clinically significant cardiovascular disease including but not limited to transient ischemic attack, stroke, cardiac arrhythmias, syncope, unstable angina, myocardial infarction in the 6 months prior to screening, congestive heart failure, or uncontrolled hypertension. (Uncontrolled hypertension is defined as a systolic blood pressure ≥160 mmHg or a diastolic blood pressure ≥100 mmHg based on an average of three resting determinations in the sitting position with an appropriately sized cuff).
- Resting heart rate <45 or >110 bpm.
- On screening ECG or by history:
- A marked baseline prolongation of QT/QTcF interval (e.g., repeated demonstration of a QTcF interval > 450 msec for males and >470 msec for females).
- A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or a family history of sudden cardiac death of unknown origin.
- Kidney disease, kidney transplant, or estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 based on the CKD-EPI Creatinine Equation (NKF 2009; https://www.kidney.org/content/ckd-epi-creatinine-equation-2009).
- Significant lung disease requiring chronic daily medication including chronic obstructive pulmonary disease (COPD), emphysema, pulmonary fibrosis, or asthma.
- Untreated obesity hypoventilation syndrome (OHS) or obstructive sleep apnea (OSA).
- History of or active (acute or chronic) liver disease other than nonalcoholic fatty liver disease (NAFLD)/ nonalcoholic steatohepatitis (NASH), such as but not limited to autoimmune liver disease, viral hepatitis, genetic hemochromatosis, primary biliary cirrhosis, Wilson disease, alpha-1-antitrypsin deficiency, alcohol liver disease, acute fatty liver of pregnancy or drug induced (including acetaminophen) liver disease.
- History of or treatment for clinically significant gastroparesis, inflammatory bowel disease, or any surgery of the upper gastrointestinal tract with the exception of cholecystectomy, or minor gastric procedures that are approved by the medical monitor.
- History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
- History of acute pancreatitis within one year of screening or chronic pancreatitis of any cause.
- Serum triglyceride concentrations exceeding 500 mg/dL.
- HbA1c >9.0%.
- Familial (mother/father/sibling) and/or personal history of retinal detachment any time in the past.
- Any history of or current diagnosis of Glaucoma.
- Evidence of the following on screening ophthalmologic examination:
- Peripheral retinal pathology requiring treatment, retinal tears, or lattice that require treatment.
- Diabetic retinopathy with macula exudates or macula edema as shown by optical coherence tomography (OCT) and examination.
- Any active macular disease that affects the vision, including macula pucker (epiretinal membrane) and macular degeneration.
- Visually significant cataract as determined by ophthalmologist.
- Any previous intravitreal injection of anti-VEGF agents for macular degeneration.
- History of prior vitrectomy.
- History of malignant neoplasms within 5 years of screening, except for basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer that is not currently or expected to require radiation therapy, chemotherapy and/or surgical interventions or to initiate hormonal treatment.
- History of organ transplantation.
- Received a COVID-19 vaccine less than 1 week prior to dosing (Visit 2 / Day 1) and/or plans to receive a COVID-19 vaccine during the study period.
- History of significant drug abuse within one year prior to Screening or frequent use of soft drugs (such as marijuana) within 3 months prior to the Screening visit, or hard drugs (such as cocaine, phencyclidine [PCP], opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- History of alcoholism in the last 2 years or current evidence of excessive alcohol consumption as assessed by screening evaluation using the Alcohol Use Disorders Identification Test (AUDIT, Thompson 2018 [Appendix A]), and history of regular alcohol consumption exceeding approximately 14 drinks/week for men and 7 drinks/week for women [1 drink = 4 ounces (120 mL) of wine or 12 ounces (360 mL) of beer or 1 ounce (30 mL) of hard liquor] within 6 months of Screening, as determined by the Investigator.
- Positive urine drug screen for drugs of abuse or positive phosphatidylethanol (PEth) blood test result >25 ng/mL at Screening.
- Current regular vaping or more than 5 cigarettes or the equivalent per week. Use of nicotine patches for smoking cessation is permitted.
- Positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV1/2) antibody.
- Neutropenia, defined as absolute neutrophil count ≤1000/μL.
- Serum AST or ALT >5 x upper limit of normal (ULN) at screening. (One repeat test may be allowed within 7 days at the discretion of the Investigator).
- Total bilirubin > ULN, unless due to Gilbert's syndrome or if considered normal variability in the absence of other clinically relevant liver impairment as approved by Medical Monitor.
- International normalized ratio (INR) ≥1.3 at screening if there is other evidence of potential significant liver impairment.
- Participation in another clinical trial at the time of screening or exposure to any investigational agent, including topical, within 30 days of screening or 5 half-lives, if half-life known.
- No tattoo or body piercings during the course of the study. Any underlying physical or psychological medical condition that, in the opinion of the Investigator or sponsor, would make it unlikely that the subject is able comply with the study requirements or would be unable to complete the study.
- Any condition that the investigator believes would interfere with his/her ability to provide written informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
- Known or potential hypersensitivity to HU6 or its excipients.
- Prohibited Medications (Current Use):
- Any herbal supplement, over the counter drug, mail order or prescription drug for weight loss.
- Prescription or over the counter stimulants including: dextroamphetamine/Dexedrine, dextroamphetamine/amphetamine combination product/Adderall, or methylphenidate (Ritalin®, Concerta®).
- Thiazolidinediones (TZD): pioglitazone/Actos, rosiglitazone/Avandia.
- Glucagon-like peptide 1 (GLP1) agonists: exenatide/Byetta/Bydureon, lixisenatide/Adlyxin, liraglutide/Victoza, dulaglutide/Trulicity, semaglutide/Ozempic.
- Sodium-glucose cotransporter-2 (SGLT2) inhibitors: canagliflozin/Invokana, dapagliflozin/Farxiga, empagliflozin/Jardiance, ertugliflozin/Steglatro.
- Vitamin E: use of ursodiol or high dose vitamin E >400 IU/day for at least one month within in the last 6 months or started high dose vitamin E within last 3 months of screening.
- Recent (within 3 months of screening) or current use of obeticholic acid/Ocaliva, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines.
- Warfarin, heparin, factor Xa inhibitors (dabigatran betrixaban edoxaban, apixaban, and rivaroxaban).
- Concomitant medications that prolong the QT/QTc interval and are known to be associated with increased risk of Torsade des pointes as identified in the https://crediblemeds.org/ website list category of 'Known Risk' (Appendix B).
- Products with cannabidiol (CBD).
Trial locations and contacts
1 site in 1 country.
United States1 site
Prism Clinical Research
Minneapolis, Minnesota, 55114
About this study
Official title: A 61-day Randomized, Double Blind, Placebo-controlled Trial to Assess the Safety and Efficacy of Three Doses of HU6 in Subjects With Elevated Liver Fat and High Body Mass Index (28 to 45 kg/m2)
This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat.
Read the detailed description
This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat.
Subjects will be screened over a 45 day period to determine their eligibility based on specific history, physical, laboratory and imaging evaluations as per the Schedule of Assessments. Due to scheduling of the procedures, multiple visits will likely be necessary to complete the screening process. However, if all screening assessments and procedures, including the MRI, can be completed within 30 days of the first dose, then a single screening visit is permissible.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- HU6, Placebo
- 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.
HU6Drug
HU6 is active study drug
PlaceboDrug
Non-active study drug N = 20
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment: HU6 150 mg; N = 20 | Active comparator | HU6 is Active Study Drug Receives: Drug: HU6 |
| Active Treatment: HU6 300 mg; N = 20 | Active comparator | HU6 is Active Study Drug Receives: Drug: HU6 |
| Active Treatment: HU6 450 mg; N = 20 | Active comparator | HU6 is Active Study Drug Receives: Drug: HU6 |
| Placebo Comparator Non-active study drug N = 20 | Placebo comparator | Non-active Study Drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Change From Baseline in Liver Fat Content as Assessed by MRI-PDFF
Percentage of Change from Baseline in Liver Fat Content as Assessed by MRI-PDFF at Day 61
Measured: Baseline and 61 days;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start19 Apr 2021
- Primary completion30 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rivus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Eastenson, Principal investigator, Prism Clinic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874233
- Sponsor's protocol ID
- RIV-HU6-203
- Status last verified
- Apr 2023
- First submitted
- 2 May 2021
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noureddin M, Khan S, Portell F, Jorkasky D, Dennis J, Khan O, Johansson L, Johansson E, Sanyal AJ. Safety and efficacy of once-daily HU6 versus placebo in people with non-alcoholic fatty liver disease and high BMI: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Gastroenterol Hepatol. 2023 Dec;8(12):1094-1105. doi: 10.1016/S2468-1253(23)00198-X. Epub 2023 Oct 5.
PubMed 37806314
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 61-day Randomized, Double Blind, Placebo-controlled Trial to Assess the Safety and Efficacy of Three Doses of HU6 in Subjects With Elevated Liver Fat and High Body Mass Index (28 to 45 kg/m2)
- ClinicalTrials.gov ID
- NCT04874233
- Acronym / sponsor ID
- RIV-HU6-203
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rivus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat.
Detailed description
This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat.
Subjects will be screened over a 45 day period to determine their eligibility based on specific history, physical, laboratory and imaging evaluations as per the Schedule of Assessments. Due to scheduling of the procedures, multiple visits will likely be necessary to complete the screening process. However, if all screening assessments and procedures, including the MRI, can be completed within 30 days of the first dose, then a single screening visit is permissible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Treatment: HU6 150 mg; N = 20 | Active comparator | Drug: HU6HU6 is Active Study Drug |
| Active Treatment: HU6 300 mg; N = 20 | Active comparator | Drug: HU6HU6 is Active Study Drug |
| Active Treatment: HU6 450 mg; N = 20 | Active comparator | Drug: HU6HU6 is Active Study Drug |
| Placebo Comparator Non-active study drug N = 20 | Placebo comparator | Drug: PlaceboNon-active Study Drug |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Adult male or females, 28 to 65 years of age (inclusive) at the time of informed consent with BMI between 28.0 and 45.0 kg/m2 (inclusive).
- 2. Inclusion as per investigator assessment of general medical status and as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations.
- <!-- -->
- 3. Fibroscan® CAP score>300 dB/m. 4. ≥8% liver fat by MRI-PDFF. 5. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
- 6. Willing and able to comply with the requirements of the study protocol.
Key exclusion criteria (58 listed)
- Insulin-controlled diabetes.
- Pregnant or breastfeeding or plans to become pregnant.
- Intolerance to Magnetic Resonance Imaging (MRI) or with conditions contraindicated for MRI procedures including but not limited to inability to fit into MRI scanner or surgical clips/metallic implants/shrapnel. Subjects must not be claustrophobic, have a history of claustrophobia, or intolerance of closed or small spaces.
- Weight gain or loss >5% in 3 months prior to study or >10% in 6 months prior to screening.
- History of lap banding, intragastric balloon, duodenal-jejunal sleeve, or bariatric surgery within 5 years of screening, plans for bariatric surgery prior to conclusion of study participation, or plans to lose weight during this study either through a special diet, exercise program or both.
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 |
|---|---|---|
| HU6HU6 is active study drug | Drug | Active Treatment: HU6 150 mg; N = 20, Active Treatment: HU6 300 mg; N = 20, Active Treatment: HU6 450 mg; N = 20 |
| PlaceboNon-active study drug N = 20 | Drug | Placebo Comparator Non-active study drug N = 20 |
Primary outcome
Percentage of Change From Baseline in Liver Fat Content as Assessed by MRI-PDFF
Time frame: Baseline and 61 days;
Percentage of Change from Baseline in Liver Fat Content as Assessed by MRI-PDFF at Day 61
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37806314Noureddin M, Khan S, Portell F, Jorkasky D, Dennis J, Khan O, Johansson L, Johansson E, Sanyal AJ. Safety and efficacy of once-daily HU6 versus placebo in people with non-alcoholic fatty liver disease and high BMI: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Gastroenterol Hepatol. 2023 Dec;8(12):1094-1105. doi: 10.1016/S2468-1253(23)00198-X. Epub 2023 Oct 5.
- Individual participant dataSharing planned: No
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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.
Amy Eastenson principal investigator
Prism Clinic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HU6 in people with NASH - Nonalcoholic Steatohepatitis, run by Rivus Pharmaceuticals, Inc. at 1 site 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 15 inclusion and 58 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 1 Mar 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Change From Baseline in Liver Fat Content as Assessed by MRI-PDFF (time frame: Baseline and 61 days;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04874233, which also lists 1 linked publication.
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 1 Mar 2024.