Phase 2a Study of HPG1860 in Subjects With NASH

(RISE Trial)

Overseen By Nian Liang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hepagene (Shanghai) Co., Ltd.

Must not be taking: Statins, PCSK9 inhibitors

Disqualifiers: Alcohol, Renal dysfunction, Cardiac issues, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

89 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any safety data available for the treatment known as HPG1860, Placebo, Control, or Dummy Treatment?

In studies involving healthy volunteers, 19% reported side effects when given a placebo, with common issues being headaches, drowsiness, and weakness. This suggests that even inactive treatments can lead to reported side effects, highlighting the importance of understanding the context of safety data. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new drug called HPG1860 on patients with a liver disease known as NASH. The drug aims to reduce liver damage and improve liver function. Different doses of the drug will be compared over a few months.

Research Team

Naim Alkhouri

Principal Investigator

Arizona Liver Health - Tucson

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) of ≥25 kg/m2 at Screening.

You are male and you agree to use a highly effective method of contraception.

You have hepatic fat assessed by a central reader.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Baseline hepatic imaging during screening

Treatment

Participants receive HPG1860 or placebo for 12 weeks

12 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HPG1860
• Placebo

Participant Groups

Group I: HPG1860 8 mg Experimental Treatment 1 Intervention

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

Group II: HPG1860 5 mg Experimental Treatment 1 Intervention

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

Group III: HPG1860 3 mg Experimental Treatment 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Hepagene (Shanghai) Co., Ltd.

Lead Sponsor

Trials

2

Recruited

150+

Findings from Research

Adverse events (AEs) are reported in 49.1% of trial participants in placebo groups, indicating that these events are quite common and not solely due to the natural progression of conditions.

The prevalence of AEs in placebo groups (6.51%) is higher than in untreated groups (4.25%), suggesting that the nocebo effect may play a significant role in the experience of AEs during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Howick, J., Webster, R., Kirby, N., et al.[2022]

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

SPH3127 demonstrated a dose-dependent increase in exposure and effectively suppressed plasma renin activity by up to 90% for 24 hours, indicating its potential efficacy in managing conditions related to renin activity.

The drug was well tolerated among healthy individuals, with only mild adverse events reported in 29.2% of single-dose and 33.3% of multiple-dose participants, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. Jing, S., Xu, R., Yang, K., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Can Historical Control Group Data Be Used to Replace Concurrent Controls in Animal Studies? [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. [2021]