Phase 2
N=87
Phase 2a Study of HPG1860 in Subjects With NASH
NASH - Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT05338034 ↗Enrolled (actual)
87
Serious AEs
4.6%
Results posted
May 2026
Primary outcome: Primary: Safety and Tolerability of Treatment — 12; 13; 13; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HPG1860 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hepagene (Shanghai) Co., Ltd.
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Treatment |
12; 13; 13; 18 | — |
| SECONDARY Liver Fat Content |
-20.147; -7.078; -38.637; 0.682 | — |
| SECONDARY Percentage of Subjects With ≥30% Reduction in LFC From Baseline |
3; 2; 7; 0; 5; 1 | — |
| SECONDARY Change From Baseline (CFB) in Liver Fat Content (LFC) at 4 Week |
-13.915; -10.295; -24.793; -3.174 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent prior to any study-specific procedure.
- Males and females between 18 and 75 years of age
- Nonpregnant, nonlactating women.
- Male subjects must agree to utilize a highly effective method of contraception.
- Body mass index (BMI) of ≥25 kg/m2 at Screening.
- Non-cirrhotic NASH subjects.
- NASH subjects with hepatic fat assessed by a central reader
- Willing and able to adhere to study restrictions and agree to comply with study protocol.
Exclusion Criteria
- Pregnant or lactating females
- Current significant alcohol consumption
- Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor
- Renal dysfunction or nephritic syndrome or a history of nephritis
- Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes or uncontrolled T2DM
- Uncontrolled hypothyroidism
- Liver transplant and/or other significant liver disease or dysfunction
- HIV antibody positive
- Known hypersensitivity or formulation excipient
- Gastrointestinal conditions or procedures that may affect drug absorption
- Hematologic or coagulation disorders
- Unstable weight within the last 3 months
- Active malignancy
- Unexplained creatine kinase (CK) >3 × ULN
- Blood donation, blood transfusion
- Unable to undergo or contraindication to MRI procedure
- A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.
Data sourced from ClinicalTrials.gov (NCT05338034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.