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UNKNOWNPHASE1/PHASE2

Phase Ib/II Study to Evaluate the Efficacy and Safety of GH509 Versus Placebo in Patients With NASH/NAFLD

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)

NCT05784779•1Globe Biomedical Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed written informed consent.
•2. ≥ 18 years of age and \< 75 years old.
•3. BMI ≥ 18 kg/m2.
•4. 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. ≤ 5% weight change within 6 months prior to randomization.
•6. Diagnosed with T2DM.
•7. 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.
•8. 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.
•9. Serum alanine transaminase (ALT) and serum aspartate transaminase (AST) ≤ 10×ULN within 14 days prior to randomization.
•10. Serum creatinine \<1.5×ULN within 14 days prior to randomization.
+1 more criteria

Exclusion Criteria

•1. 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.
•2. Use of injected or oral antidiabetic agents within 3 months including: Thiazolidinediones; Subcutaneously administered agents; Sodium-glucose co-transporter 2 inhibitors
•3. Patients with a history of hypoglycemia within 3 months before study enrollment.
•4. Subject uses drugs historically associated with NASH/NAFLD for more than 2 weeks in the year prior to randomization.
•5. Treatment with a non-stable dose of statins, fibrates, or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in 3 months prior to randomization.
•6. LDL ≥190 mg/dL.
•7. Treatment with a non-stable dose of drugs with potential anti-NASH/NAFLD effect in the 6 months prior to randomization.
•8. 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.
•9. 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.
•10. Subject has prior or has planned bariatric surgery.
+20 more criteria

Locations (1)

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Key Dates

Start Date

February 28, 2023

Primary Completion Date

May 28, 2024

Completion Date

June 28, 2024

Last Updated

March 28, 2023

Enrollment

180

ESTIMATED participants

Conditions

NASHNAFLD

Interventions

GH509

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase Ib/II Study to Evaluate the Efficacy and Safety of GH509 Versus Placebo in Patients With NASH/NAFLD

Inclusion Criteria

Exclusion Criteria

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

Evaluation of Non-Invasive Tests for Metabolic Liver Disease

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis