Non-Alcoholic Steatohepatitis (NASH)Phase 1/2NCT04140123
Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)
A Phase 1/2 study testing ZSP1601 in people with Non-Alcoholic Steatohepatitis (NASH), run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Steatohepatitis (NASH)
- What is being tested?
- ZSP1601
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2020to 3 Aug 2021
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are required to meet the following criteria in order to be included in the trial:
- Signature signed informed consent before the trial, and fully understood the content, process and possible adverse reactions.
- Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects(including partners)have no gestation plans and must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- Male and female subjects aged 18-65 (including 18 and 65).
- B ultrasound confirmed fatty liver.
- NASH diagnosis or NASH phenotypic diagnosis.
- Liver fat ≥10% at baseline (MRI-PDFF)
Who cannot join
- Eligible subjects must not meet any of the following exclusion criteria:
- Excessive drinking for 3 consecutive months within 1 year before screening.
- Allergic constitution.
- Subjects who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
- Subjects having a history of bariatric surgery or preparing for bariatric surgery recently.
- Subjects having a history of liver transplantation or plans for liver transplantation
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- Any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers.
- Liver biopsy indicates cirrhosis or previous clinical diagnosis of cirrhosis.
- Type 1 diabetes mellitus.
- Uncontrolled type 2 diabetes mellitus (HbA1c≥8.0%)。
- Any clinically significant abnormality upon physical examination or in the clinical laboratory tests, history or presence of other causes of liver disease,but not limited to above disorders: hepatitis b or hepatitis c virus (HCV) infection and chronic alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson 's disease, alpha 1 - antitrypsin deficiency, liver, obvious abnormal liver function (ALT and AST acuity 5 x ULN or TBIL acuity 1.5 x ULN), etc.
- Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
- History of having any special food(including dragon fruit,mango,grapefruit,etc.),strenuous exercises,or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 2 weeks prior to screening.
- Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
- Presence of clinically significant abnormalities in ECG or QTcB>450ms in males,or QTcB>470ms in females.
- HIV positive.
- Clinically significant nephropathy or renal dysfunction, blood creatinine >1.5×ULN, eGFR< 60 mL/min/1.73m2 [calculation formula: Ccr:(140-age)× weight (kg) /0.818×Scr(mumol /L), female ×0.85].
- Platelet count <100×109/L.
- Antinuclear antibody (ANA) confirmed positive and clinically significant.
- Abnormal TSH with clinical significance.
- Female during pregnancy and lactation or positive serum pregnancy test.
- Patients with contraindication of MRI scan.
- Take any product contains alcohol within 24 hours prior to dosing.
- Have chocolate, any food or beverage that contains caffeine or xanthine within 24 hours prior to dosing.
- Positive for urine drug screening or history of substance abuse for a period of 5 consecutive years before screening.
- Any acute illness or concomitant medication from screening to first dosing.
- As judged by the researcher, it is not suitable to join the clinical researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Dose-increasing, Placebo-controlled，Multi-dose, 28-day Continuous Administration Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, Efficacy, and PK of ZSP1601 in Patients With Nonalcoholic Steatohepatitis
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Being tested
- ZSP1601, ZSP1601 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.
ZSP1601Drug
ZSP1601 tablets be taken orally for 28 days.
ZSP1601 PlaceboDrug
Subjects will receive matching placebo of ZSP1601
| Study group | Role | What they receive |
|---|---|---|
| ZSP1601-Dose 1 | Experimental | ZSP1601-50mg once daily Receives: Drug: ZSP1601; Drug: ZSP1601 Placebo |
| ZSP1601-Dose 2 | Experimental | ZSP1601-50mg twice daily Receives: Drug: ZSP1601; Drug: ZSP1601 Placebo |
| ZSP1601-Dose 3 | Experimental | ZSP1601-100mg once daily Receives: Drug: ZSP1601; Drug: ZSP1601 Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: ZSP1601 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo.
severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)
Measured: Initiation of study treatment (Day 1) up to 2 weeks post-treatment.
Secondary outcomes (11)
MRI-PDFF
liver fat content with Magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured: Baseline and Day 28.
TNF-α
Tumor necrosis factor alpha level in serum
Measured: Baseline and Day 28.
ALT
serum Alanine Aminotransferase
Measured: Baseline and Day 28.
AST
serum Aspartate Aminotransferase
Measured: Baseline and Day 28.
Tmax
The time after dosing when Cmax occurs (Tmax)
Measured: Day1 and day 14
Cmax
Maximum Contentration
Measured: Day1 and day 14
t1/2z
t1/2z is defined as the time to decline half of the drug concentration in plasma.
Measured: Day1 and day 14
Rac of Cmax
Rac of ZSP1601 Peak Plasma Concentration at steady state
Measured: Day1 and day 14
DF of ZSP1601 at steady status
Multiple-dose plasma PK parameter: DF of ZSP1601 at steady status
Measured: Day1 and day 14
AUClast（AUC0-t）
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Measured: Baseline (0h) and day 14
Rac of AUC
RAC of ZSP1601 Area under the plasma concentration versus time curve at steady state
Measured: Day1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start23 Jun 2020
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Steatohepatitis (NASH)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140123
- Sponsor's protocol ID
- ZSP1601-18-02
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2019
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu Y, Li H, Zhang H, Chen X, Chen J, Xu Z, You H, Dong R, Peng Y, Li J, Li X, Wu D, Zhang L, Cao D, Jin H, Qiu D, Yang A, Lou J, Zhu X, Niu J, Ding Y. ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial. Nat Commun. 2023 Oct 12;14(1):6409. doi: 10.1038/s41467-023-42162-0.
PubMed 37828034
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Dose-increasing, Placebo-controlled，Multi-dose, 28-day Continuous Administration Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, Efficacy, and PK of ZSP1601 in Patients With Nonalcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT04140123
- Acronym / sponsor ID
- ZSP1601-18-02
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 25 Oct 2019 (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.
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZSP1601-Dose 1 | Experimental | Drug: ZSP1601, Drug: ZSP1601 PlaceboZSP1601-50mg once daily |
| ZSP1601-Dose 2 | Experimental | Drug: ZSP1601, Drug: ZSP1601 PlaceboZSP1601-50mg twice daily |
| ZSP1601-Dose 3 | Experimental | Drug: ZSP1601, Drug: ZSP1601 PlaceboZSP1601-100mg once daily |
| Placebo | Placebo comparator | Drug: ZSP1601 PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects are required to meet the following criteria in order to be included in the trial:
Key exclusion criteria (27 listed)
- Eligible subjects must not meet any of the following exclusion criteria:
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 |
|---|---|---|
| ZSP1601ZSP1601 tablets be taken orally for 28 days. | Drug | ZSP1601-Dose 1, ZSP1601-Dose 2, ZSP1601-Dose 3 |
| ZSP1601 PlaceboSubjects will receive matching placebo of ZSP1601 | Drug | Placebo, ZSP1601-Dose 1, ZSP1601-Dose 2, ZSP1601-Dose 3 |
Primary outcome
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo.
Time frame: Initiation of study treatment (Day 1) up to 2 weeks post-treatment.
severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)
11 secondary outcomes
MRI-PDFF
Time frame: Baseline and Day 28.
TNF-α
Time frame: Baseline and Day 28.
ALT
Time frame: Baseline and Day 28.
AST
Time frame: Baseline and Day 28.
Tmax
Time frame: Day1 and day 14
Cmax
Time frame: Day1 and day 14
t1/2z
Time frame: Day1 and day 14
Rac of Cmax
Time frame: Day1 and day 14
DF of ZSP1601 at steady status
Time frame: Day1 and day 14
AUClast（AUC0-t）
Time frame: Baseline (0h) and day 14
Rac of AUC
Time frame: Day1 and day 14
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 Oct 2021.
- Derived from this study: PubMed 37828034Hu Y, Li H, Zhang H, Chen X, Chen J, Xu Z, You H, Dong R, Peng Y, Li J, Li X, Wu D, Zhang L, Cao D, Jin H, Qiu D, Yang A, Lou J, Zhu X, Niu J, Ding Y. ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial. Nat Commun. 2023 Oct 12;14(1):6409. doi: 10.1038/s41467-023-42162-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZSP1601 in people with Non-Alcoholic Steatohepatitis (NASH), run by Guangdong Raynovent Biotech Co., Ltd 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 8 inclusion and 27 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 Oct 2021. 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. 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 combined 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.
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?
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?
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo. (time frame: Initiation of study treatment (Day 1) up to 2 weeks post-treatment.). 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 NCT04140123, 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 11 Oct 2021.