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

NCT05784779 | Unknown Phase 1

• 1 other identifier: NASH-GH509-2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

NASH; NAFLD

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 weeks

Secondary Outcomes (7)

• Change in liver fat as assessed by MRI-PDFF

  12 weeks

• Proportion of MRI-PDFF responders

  12 weeks

• Change in liver enzymes as assessed by serum alanine aminotransferase (ALT)

  12 weeks

• Change in glycemic control as assessed by HbA1c

  12 weeks

• Change in glycemic control as assessed by fasting blood glucose (FBG)

  12 weeks

Study Arms (2)

GH509

EXPERIMENTAL

Drug: GH509

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GH509 DRUG

Orally, once daily before bedtime (qhs)

GH509

Placebo DRUG

Orally, once daily before bedtime (qhs)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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:.

Sponsors & Collaborators

• 1Globe Biomedical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 310015, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 27, 2023
• Study Start: February 28, 2023
• Primary Completion: May 28, 2024
• Study Completion: June 28, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CN (1)