Non-Alcoholic SteatohepatitisPhase 2NCT05397379
A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
A Phase 2 study testing HEC96719 in people with Non-Alcoholic Steatohepatitis, run by Sunshine Lake Pharma Co., Ltd. at 9 sites in China.
Trial summary
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Steatohepatitis
- What is being tested?
- HEC96719
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 9 sitesChina
- Study dates
- 15 Nov 2021to 5 Sep 2023
- Phase
- Phase 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
- An informed consent document must be signed and dated by the subject
- Male or female, 18 to 65 years of age
- Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
- Presumed NASH based on clinical characteristics or prior liver biopsy
- MRI PDFF liver fat content ≥ 10 %
Who cannot join
- previous diagnosis of other forms of chronic liver disease
- Laboratory Screening Results:
- AST > 5 x ULN
- ALP > 3 x ULN
- Total bilirubin > 1.5 x ULN
- Albumin < 3.2 g/dL
Show all 13Show fewer
- INR > 1.3
- Platelet count < 100,000 /mm3
- creatinine clearance <60 ml/min (based on Cockroft Gault method)
- previous exposure to OCA
- uncontrolled diabetes mellitus
- presence of cirrhosis
- patients with contraindications to MRI imaging
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking University People's Hospital
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
Hunan Provincial People's Hospital
Changsha, Hunan
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Affiliated Hospitol of Guangdong Medical University
Guangzhou, Guangdong
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospitol of Wenzhou Medical University
Wenzhou, Zhejiang
Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology
Wuhan, Hubei
The First Affiliated Hospitol of Xi'an Jiaotong University
Xi’an, Shanxi
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered HEC96719 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.
- Conditions
- Non-Alcoholic Steatohepatitis
- Being tested
- HEC96719, 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.
HEC96719Drug
Oral tablets
PlaceboDrug
Comparator
| Study group | Role | What they receive |
|---|---|---|
| HEC96719 0.25 mg | Experimental | Oral dose once daily for 12 weeks Receives: Drug: HEC96719 |
| HEC96719 0.35 mg | Experimental | Oral dose once daily for 12 weeks Receives: Drug: HEC96719 |
| HEC96719 0.5 mg | Experimental | Oral dose once daily for 12 weeks Receives: Drug: HEC96719 |
| HEC96719 0.25 mg bid | Experimental | Oral dose twice daily for 12 weeks Receives: Drug: HEC96719 |
| Placebo | Placebo comparator | Oral dose once or twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 12 weeks
Secondary outcomes (5)
Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12
Measured: Baseline and Week 12
Plasma concentration of HEC96719 - AUC
Area under the curve
Measured: 4 weeks
Plasma concentration of HEC96719 - Cmax
Maximum observed concentration
Measured: 4 weeks
Plasma concentration of HEC96719 - Tmax
Time to reach maximum measured plasma concentration
Measured: 4 weeks
Plasma concentration of HEC96719 - t1/2
Determination of half-life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Nov 2021
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinlin Hou, Doctor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397379
- Sponsor's protocol ID
- HEC96719-NASH-201
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered HEC96719 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT05397379
- Acronym / sponsor ID
- HEC96719-NASH-201
- Conditions
- Non-Alcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 31 May 2022 (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 is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HEC96719 0.25 mg | Experimental | Drug: HEC96719Oral dose once daily for 12 weeks |
| HEC96719 0.35 mg | Experimental | Drug: HEC96719Oral dose once daily for 12 weeks |
| HEC96719 0.5 mg | Experimental | Drug: HEC96719Oral dose once daily for 12 weeks |
| HEC96719 0.25 mg bid | Experimental | Drug: HEC96719Oral dose twice daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral dose once or twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An informed consent document must be signed and dated by the subject
- Male or female, 18 to 65 years of age
- Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
- Presumed NASH based on clinical characteristics or prior liver biopsy
- MRI PDFF liver fat content ≥ 10 %
Key exclusion criteria (13 listed)
- previous diagnosis of other forms of chronic liver disease
- Laboratory Screening Results:
- previous exposure to OCA
- uncontrolled diabetes mellitus
- presence of cirrhosis
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 |
|---|---|---|
| HEC96719Oral tablets | Drug | HEC96719 0.25 mg, HEC96719 0.25 mg bid, HEC96719 0.35 mg, HEC96719 0.5 mg |
| PlaceboComparator | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 12 weeks
5 secondary outcomes
Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12
Time frame: Baseline and Week 12
Plasma concentration of HEC96719 - AUC
Time frame: 4 weeks
Plasma concentration of HEC96719 - Cmax
Time frame: 4 weeks
Plasma concentration of HEC96719 - Tmax
Time frame: 4 weeks
Plasma concentration of HEC96719 - t1/2
Time frame: 4 weeks
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 21 Feb 2024.
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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.
Jinlin Hou, Doctor study chair
Nanfang Hospital, Southern Medical University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HEC96719 in people with Non-Alcoholic Steatohepatitis, run by Sunshine Lake Pharma Co., Ltd. at 9 sites 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 13 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 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?
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 of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 12 weeks). 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 21 Feb 2024.