Phase 2a Study of HPG1860 in Subjects With NASH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

NCT05692492

Nonalcoholic Steatohepatitis (NASH)

ACTIVE_NOT_RECRUITING PHASE2

HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes

NCT05623189

Nonalcoholic Steatohepatitis (NASH) Type 2 Diabetes

COMPLETED PHASE2

A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

NCT03656744

Fatty Liver, Nonalcoholic NAFLD Nonalcoholic Fatty Liver Disease +3 more

COMPLETED PHASE2

Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

NCT03248882

Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

COMPLETED PHASE2

A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

NCT00492700

Non Alcoholic Steatohepatitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH. Screening will occur up to 5 weeks prior to randomization; all eligible subjects will have baseline hepatic imaging during Screening, prior to randomization. Approximately 80 eligible subjects will be randomized 1:1:1:1 on Day 1/Week 0 (T1) to receive either HPG1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks. Following a preplanned interim analysis, a dose cohort may be dropped and/or added.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NASH - Nonalcoholic Steatohepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

During this study, subjects, investigators, the Sponsor, and the clinical research organization (CRO) (except specific vendors whose role in study conduct requires their unblinding, eg, personnel operationally associated with the interactive response technology \[IRT\]) will be blinded to the study intervention assignment. Study team personnel will remain blinded throughout the study with the exception of a Sponsor Committee who will review interim analysis results and make decisions regarding dropping and/or adding a treatment cohort and an unblinded study team member assigned to monitor that at least 6 subjects in each dose cohort had serial PK measurements taken.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HPG1860 3 mg

20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.

Group Type EXPERIMENTAL

HPG1860

Intervention Type DRUG

The dosage form for clinical research is a dry-filled capsule for oral administration manufactured as strengths of 3 mg, 5 mg, and 8 mg.

HPG1860 5 mg

20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.

Group Type EXPERIMENTAL

HPG1860

Intervention Type DRUG

The dosage form for clinical research is a dry-filled capsule for oral administration manufactured as strengths of 3 mg, 5 mg, and 8 mg.

HPG1860 8 mg

20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.

Group Type EXPERIMENTAL

HPG1860

Intervention Type DRUG

The dosage form for clinical research is a dry-filled capsule for oral administration manufactured as strengths of 3 mg, 5 mg, and 8 mg.

Placebo

20 subjects will be treated with Placebo once daily at a similar time with or without food.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HPG1860

The dosage form for clinical research is a dry-filled capsule for oral administration manufactured as strengths of 3 mg, 5 mg, and 8 mg.

Intervention Type DRUG

Placebo

Capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provision of written informed consent prior to any study-specific procedure.
2. Males and females between 18 and 75 years of age
3. Nonpregnant, nonlactating women.
4. Male subjects must agree to utilize a highly effective method of contraception.
5. Body mass index (BMI) of ≥25 kg/m2 at Screening.
6. Non-cirrhotic NASH subjects.
7. NASH subjects with hepatic fat assessed by a central reader
8. Willing and able to adhere to study restrictions and agree to comply with study protocol.

Exclusion Criteria

1. Pregnant or lactating females
2. Current significant alcohol consumption
3. Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor
4. Renal dysfunction or nephritic syndrome or a history of nephritis
5. Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia
6. Uncontrolled hypertension
7. Type 1 diabetes or uncontrolled T2DM
8. Uncontrolled hypothyroidism
9. Liver transplant and/or other significant liver disease or dysfunction
10. HIV antibody positive
11. Known hypersensitivity or formulation excipient
12. Gastrointestinal conditions or procedures that may affect drug absorption
13. Hematologic or coagulation disorders
14. Unstable weight within the last 3 months
15. Active malignancy
16. Unexplained creatine kinase (CK) \>3 × ULN
17. Blood donation, blood transfusion
18. Unable to undergo or contraindication to MRI procedure
19. A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No