NASHPhase 1/2NCT05784779
Phase Ib/II Study to Evaluate the Efficacy and Safety of GH509 Versus Placebo in Patients With NASH/NAFLD
A Phase 1/2 study testing GH509 in people with NASH and NAFLD, run by 1Globe Biomedical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase Ib/II, randomized, double-blind, placebo-controlled, international multi-center clinical study to investigate the efficacy and safety of GH509 in subjects with NASH/NAFLD Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- GH509
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to 28 Jun 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- ≥ 18 years of age and < 75 years old.
- BMI ≥ 18 kg/m2.
- Histologically confirmed NASH (defined as the presence of steatosis, inflammation, and ballooning) within 6 months prior to randomization with stage 2-3 fibrosis according to the NASH Clinical Research Network (CRN) classification OR NAFLD diagnosed by imaging assessment (MRI-PDFF ≥10% within 2 months prior to randomization).
- ≤ 5% weight change within 6 months prior to randomization.
- Diagnosed with T2DM.
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- For male or female patient of childbearing potential: Must agree to use contraception or take measures to avoid pregnancy during the study, and for 30 days (female) or 90 days (male) after the last dose of GH509/placebo.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG.
- Serum alanine transaminase (ALT) and serum aspartate transaminase (AST) ≤ 10×ULN within 14 days prior to randomization.
- Serum creatinine <1.5×ULN within 14 days prior to randomization.
- Platelets count ≥ 100,000/mm3 within 14 days prior to randomization.
Who cannot join
- Subjects with a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening.
- Use of injected or oral antidiabetic agents within 3 months including: Thiazolidinediones; Subcutaneously administered agents; Sodium-glucose co-transporter 2 inhibitors
- Patients with a history of hypoglycemia within 3 months before study enrollment.
- Subject uses drugs historically associated with NASH/NAFLD for more than 2 weeks in the year prior to randomization.
- Treatment with a non-stable dose of statins, fibrates, or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in 3 months prior to randomization.
- LDL ≥190 mg/dL.
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- Treatment with a non-stable dose of drugs with potential anti-NASH/NAFLD effect in the 6 months prior to randomization.
- Participated in a clinical research study with any investigational product being evaluated for the treatment of diabetes, weight loss, or NASH/NAFLD in the 6 months prior to randomization.
- Subject is listed for orthotopic liver transplant (OLT) or has medical history of: biliary diversion, organ transplant/bone marrow transplant or undergoing immunosuppressive therapy, hepatocellular, pancreatic, thyroid carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN 2) or other malignant disease.
- Subject has prior or has planned bariatric surgery.
- Subject had major surgery within 8 weeks prior to randomization, significant traumatic injury, or anticipation of need for major surgical procedure during the course of the study.
- Presence of cirrhosis on liver biopsy.
- Model for End-stage Liver Disease (MELD) score greater than 12.
- Subject with clinical evidence of hepatic decompensation.
- Subject has evidence of other forms of chronic liver disease:.
- Acute cholecystitis or known biliary obstruction.
- Acute or chronic pancreatitis or administration of total parenteral nutrition within 6 months prior to randomization.
- Subject has gastrointestinal disorder(s) which would significantly impede the absorption of an oral agent.
- Subject has concurrent severe infection including diagnoses of fever of unknown origin.
- Clinically significant and uncontrolled cardiovascular disease within 12 months prior to randomization; cerebrovascular disease, grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or grade II or greater peripheral vascular disease.
- Subject with history of human immunodeficiency virus (HIV) infection.
- Subject with known allergies to the study drug or any of its excipients.
- Subject with an active, serious medical disease with likely life expectancy of less than 5 years.
- Subject with active substance abuse, including alcohol and/or inhaled or injection drugs, in the year prior to randomization.
- Subject has participated in an investigational new drug (IND) trial in the 30 days before randomization.
- Subject has been previously exposed to GH509.
- Unable or unwilling to swallow GH509/placebo daily.
- Ineligibility for MRI.
- Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
- Subject has any other condition which would impede compliance or hinder completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310015
Baiyun Zhao, 0571-88358070, 2026609969@qq.com
About this study
Official title: Phase Ib/II Study to Evaluate the Efficacy and Safety of GH509 Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)/Non-alcoholic Fatty Liver Disease (NAFLD)
This is a Phase Ib/II, randomized, double-blind, placebo-controlled, international multi-center clinical study to investigate the efficacy and safety of GH509 in subjects with NASH/NAFLD
- Being tested
- GH509, 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.
GH509Drug
Orally, once daily before bedtime (qhs)
PlaceboDrug
Orally, once daily before bedtime (qhs)
| Study group | Role | What they receive |
|---|---|---|
| GH509 | Experimental | Not described Receives: Drug: GH509 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine recommended Phase II dose (RP2D)
Determine the recommended Phase II dose (RP2D) of GH509, which is defined as the dose level that is well tolerated by patients
Measured: 12 weeks
Change in liver fat content as assessed by MRI-PDFF
Proportion of patients achieving ≥30% hepatic fat reduction (assessed by MRI-PDFF) from baseline after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (7)
Change in liver fat as assessed by MRI-PDFF
Change in percent of hepatic fat fraction assessed by MRI-PDFF from baseline after 12 weeks of treatment.
Measured: 12 weeks
Proportion of MRI-PDFF responders
Proportion of patients achieving ≥30% hepatic fat reduction assessed by MRI-PDFF from baseline after 12 weeks of treatment
Measured: 12 weeks
Change in liver enzymes as assessed by serum alanine aminotransferase (ALT)
Change in concentration of serum alanine aminotransferase (ALT) from baseline after 12 weeks of treatment.
Measured: 12 weeks
Change in glycemic control as assessed by HbA1c
Change in percent of hemoglobin A1c (HbA1c) from baseline after 12 weeks of treatment.
Measured: 12 weeks
Change in glycemic control as assessed by fasting blood glucose (FBG)
Change in concentration of fasting blood glucose (FBG) from baseline after 12 weeks of treatment.
Measured: 12 weeks
Change in weight control as assessed by weight loss
Change in body weight from baseline after 12 weeks of treatment.
Measured: 12 weeks
Tolerability and safety as assessed by incidence of adverse events
Number and percentage of adverse events and serious adverse events.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start28 Feb 2023
- Primary completion28 May 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1Globe Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784779
- Sponsor's protocol ID
- NASH-GH509-2
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 28 Mar 2023
- 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study to Evaluate the Efficacy and Safety of GH509 Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)/Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT05784779
- Acronym / sponsor ID
- NASH-GH509-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- 1Globe Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 28 May 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 27 Mar 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.
This is a Phase Ib/II, randomized, double-blind, placebo-controlled, international multi-center clinical study to investigate the efficacy and safety of GH509 in subjects with NASH/NAFLD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH509 | Experimental | Drug: GH509 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent.
- ≥ 18 years of age and < 75 years old.
- BMI ≥ 18 kg/m2.
- Histologically confirmed NASH (defined as the presence of steatosis, inflammation, and ballooning) within 6 months prior to randomization with stage 2-3 fibrosis according to the NASH Clinical Research Network (CRN) classification OR NAFLD diagnosed by imaging assessment (MRI-PDFF ≥10% within 2 months prior to randomization).
- ≤ 5% weight change within 6 months prior to randomization.
Key exclusion criteria (30 listed)
- Subjects with a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening.
- Use of injected or oral antidiabetic agents within 3 months including: Thiazolidinediones; Subcutaneously administered agents; Sodium-glucose co-transporter 2 inhibitors
- Patients with a history of hypoglycemia within 3 months before study enrollment.
- Subject uses drugs historically associated with NASH/NAFLD for more than 2 weeks in the year prior to randomization.
- Treatment with a non-stable dose of statins, fibrates, or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in 3 months prior to randomization.
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 |
|---|---|---|
| GH509Orally, once daily before bedtime (qhs) | Drug | GH509 |
| PlaceboOrally, once daily before bedtime (qhs) | Drug | Placebo |
Primary outcome
Determine recommended Phase II dose (RP2D)
Time frame: 12 weeks
Determine the recommended Phase II dose (RP2D) of GH509, which is defined as the dose level that is well tolerated by patients
Change in liver fat content as assessed by MRI-PDFF
Time frame: 12 weeks
Proportion of patients achieving ≥30% hepatic fat reduction (assessed by MRI-PDFF) from baseline after 12 weeks of treatment
7 secondary outcomes
Change in liver fat as assessed by MRI-PDFF
Time frame: 12 weeks
Proportion of MRI-PDFF responders
Time frame: 12 weeks
Change in liver enzymes as assessed by serum alanine aminotransferase (ALT)
Time frame: 12 weeks
Change in glycemic control as assessed by HbA1c
Time frame: 12 weeks
Change in glycemic control as assessed by fasting blood glucose (FBG)
Time frame: 12 weeks
Change in weight control as assessed by weight loss
Time frame: 12 weeks
Tolerability and safety as assessed by incidence of adverse events
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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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.
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 GH509 in people with NASH and NAFLD, run by 1Globe Biomedical 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 11 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 28 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine recommended Phase II dose (RP2D) (time frame: 12 weeks). 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 28 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.